The Senior MSAT/Process Engineer will support the GMP manufacturing of Humacyte’s unique HAV and related products with limited supervision and guidance. This role will collaborate effectively with personnel in Manufacturing, Engineering, Process Development, Quality Assurance, and Quality Control utilizing strong communication, technical expertise and influencing skills to maintain and improve manufacturing operations.
Remote Work Designation : Not Remote
Major Accountabilities:
Serves as a process expert in HAV production systems; able to fully understand the manufacturing process
Primary responsible person to ensure bioprocessing equipment is ready for use when required
Identifies technical issues on bioprocessing equipment and initiates activities to resolve the issue quickly. Identifies and implements procedures and activities to prevent the same issue from occurring.
Lead efforts in troubleshooting out-of-trend manufacturing processes, providing the intellectual, scientific and engineering leadership to identify and implement corrective actions
Provides guidance and is accountable for determining the root causes of equipment related deviations in a timely and conclusive manner.
Ensures deep understanding of standards of practice, process science and departmental policies through participation in training and development opportunities
Provides comprehensive training and guidance to operations staff
Partner with Process Development to ensure successful process transfer
Assist in equipment selection and design, qualification, and start up activities. Work with Bioprocessing to ensure robust procedures are utilized for operation of equipment
Develop and execute test protocols, vendor site visits, FAT/SAT, etc.
Work with the Validation team to develop and execute validation strategies
Identify continuous improvement opportunities in terms of cost savings, process robustness, and manufacturing efficiency gains
Special Competencies:
Possess a demonstrated proficiency working in a Process Engineering role with a clear understanding of GMP manufacturing
Possess a demonstrated technical foundation of cell- and tissue- based products
Strong Scientific and Engineering technical experience performing and supporting cell culture based bioprocessing activities, using adherent mammalian cells preferred
Experience supporting and troubleshooting single use bioprocessing technologies as well as fixed stainless steel bioprocessing equipment
Experience leading projects related to bioprocessing deviations, change control, process optimization, technical troubleshooting, and bioprocessing process changes
Works and leads well in a team environment
Strong experience working cross functionally within a BioPharma Bioprocessing organization
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Represents the organization in a positive and professional manner
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross functional team
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Always observe safety precautions and regulations in all areas where duties are performed
Responsible for reporting all safety hazards and potential unsafe working conditions
Reports to work on time and as scheduled
Qualifications:
BS degree in relevant discipline, required.
Master’s degree or above in related discipline, preferred.
Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, or process development required
10 years of relevant pharma or biotech industry experience, minimum 5 years GMP experience required
Apr 24, 2024
Full time
The Senior MSAT/Process Engineer will support the GMP manufacturing of Humacyte’s unique HAV and related products with limited supervision and guidance. This role will collaborate effectively with personnel in Manufacturing, Engineering, Process Development, Quality Assurance, and Quality Control utilizing strong communication, technical expertise and influencing skills to maintain and improve manufacturing operations.
Remote Work Designation : Not Remote
Major Accountabilities:
Serves as a process expert in HAV production systems; able to fully understand the manufacturing process
Primary responsible person to ensure bioprocessing equipment is ready for use when required
Identifies technical issues on bioprocessing equipment and initiates activities to resolve the issue quickly. Identifies and implements procedures and activities to prevent the same issue from occurring.
Lead efforts in troubleshooting out-of-trend manufacturing processes, providing the intellectual, scientific and engineering leadership to identify and implement corrective actions
Provides guidance and is accountable for determining the root causes of equipment related deviations in a timely and conclusive manner.
Ensures deep understanding of standards of practice, process science and departmental policies through participation in training and development opportunities
Provides comprehensive training and guidance to operations staff
Partner with Process Development to ensure successful process transfer
Assist in equipment selection and design, qualification, and start up activities. Work with Bioprocessing to ensure robust procedures are utilized for operation of equipment
Develop and execute test protocols, vendor site visits, FAT/SAT, etc.
Work with the Validation team to develop and execute validation strategies
Identify continuous improvement opportunities in terms of cost savings, process robustness, and manufacturing efficiency gains
Special Competencies:
Possess a demonstrated proficiency working in a Process Engineering role with a clear understanding of GMP manufacturing
Possess a demonstrated technical foundation of cell- and tissue- based products
Strong Scientific and Engineering technical experience performing and supporting cell culture based bioprocessing activities, using adherent mammalian cells preferred
Experience supporting and troubleshooting single use bioprocessing technologies as well as fixed stainless steel bioprocessing equipment
Experience leading projects related to bioprocessing deviations, change control, process optimization, technical troubleshooting, and bioprocessing process changes
Works and leads well in a team environment
Strong experience working cross functionally within a BioPharma Bioprocessing organization
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Represents the organization in a positive and professional manner
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross functional team
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Always observe safety precautions and regulations in all areas where duties are performed
Responsible for reporting all safety hazards and potential unsafe working conditions
Reports to work on time and as scheduled
Qualifications:
BS degree in relevant discipline, required.
Master’s degree or above in related discipline, preferred.
Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, or process development required
10 years of relevant pharma or biotech industry experience, minimum 5 years GMP experience required
The Manufacturing Technical Operations III provides basic to advanced technical support for the manufacturing process and is a key liaison between the manufacturing and Humacyte MSAT teams.
Remote Work Designation : Onsite/Not Remote
Major Accountabilities:
Performs moderate to advanced scope processes and serves as a hands-on resource in Manufacturing Humacyte’s regenerative vessels by:
Provides daily technical floor support for clinical or commercial manufacturing operations.
Utilizes advanced process knowledge to identify and provide primary response to manufacturing events and ensures troubleshooting support for challenges identified.
Interfaces and acts as liaison between Manufacturing Operations and Manufacturing Science and Technology teams.
Performs deviation management support, including initiation, impact assessment, and investigation ownership as needed.
Performs daily activities required of vessel production as needed to support peaks in production volume.
Leads change control or small to mid-scale projects.
Provides compliance review and/or approval for relevant GMP documents, deviations, CAPAs, change controls, SOPs as needed.
Recognizes and solves typical and atypical problems that occur in own work area without supervisory approval.
Supports projects of moderate to large scope (e.g. operational excellence, safety).
Supports the collection and tracking of area metrics and process control data.
Ensures process steps are executed according to defined SOPs and BPRs and partners with team members to ensure understanding and accuracy.
Ensures thorough and proper documentation of activities in accordance with cGMPs.
Adheres to the proper handling of chemically hazardous goods.
Interfaces with process automation and electronic business systems.
Supports, and may lead, the revisions of SOPs and BPRs.
Supports, and may lead, qualifications and validation activities, as assigned.
In collaboration with Bioprocessing leadership, recognizes, troubleshoots, and initiates deviations for process issues of moderate scope.
Supports team effort in the effective and timely completion of root cause investigations and CAPA implementation.
Provides continuous training of other team members on standard roles as needed.
Ensures Humacyte or other required trainings/certifications are up to date.
Other duties, as assigned.
Special Skills:
Works within clearly defined standard operating procedures (SOPs) and/or scientific methods.
Uses advanced knowledge of cGMP manufacturing, Humacyte’s manufacturing process, analytical skills, and application of scientific methods or operational processes to perform a variety of activities.
Provides recommended solutions and steps for resolution to problems of moderate complexity to leadership.
Identifies areas or situations with greater complexity and partners with the Humacyte MSAT team to ensure appropriate resolution.
Possesses deep and strong technical skills and the ability to translate those technical skills into problem solving and solutions.
Has ability to differentiate between important and less important tasks within own work and act accordingly.
Strong, proactive communicator that is able to interface effectively across multiple departments with support as needed.
Qualifications:
Requires a Bachelor’s Degree, or equivalent on the job experience. Master’s degree or above preferred.
5+ years of previous experience in pharmaceutical, biotechnology, and/or sterile production environments, required.
Strong knowledge of cGMP requirements, required.
Experience executing SOPs and demonstrated thorough and strong documenting work, required.
Moderate to advanced mechanical aptitude or knowledge of electrical / mechanical equipment, preferred.
Previous cell culture experience, highly preferred.
Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines.
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Excellent communication and interpersonal skills
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross-functional team environment
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Apr 24, 2024
Full time
The Manufacturing Technical Operations III provides basic to advanced technical support for the manufacturing process and is a key liaison between the manufacturing and Humacyte MSAT teams.
Remote Work Designation : Onsite/Not Remote
Major Accountabilities:
Performs moderate to advanced scope processes and serves as a hands-on resource in Manufacturing Humacyte’s regenerative vessels by:
Provides daily technical floor support for clinical or commercial manufacturing operations.
Utilizes advanced process knowledge to identify and provide primary response to manufacturing events and ensures troubleshooting support for challenges identified.
Interfaces and acts as liaison between Manufacturing Operations and Manufacturing Science and Technology teams.
Performs deviation management support, including initiation, impact assessment, and investigation ownership as needed.
Performs daily activities required of vessel production as needed to support peaks in production volume.
Leads change control or small to mid-scale projects.
Provides compliance review and/or approval for relevant GMP documents, deviations, CAPAs, change controls, SOPs as needed.
Recognizes and solves typical and atypical problems that occur in own work area without supervisory approval.
Supports projects of moderate to large scope (e.g. operational excellence, safety).
Supports the collection and tracking of area metrics and process control data.
Ensures process steps are executed according to defined SOPs and BPRs and partners with team members to ensure understanding and accuracy.
Ensures thorough and proper documentation of activities in accordance with cGMPs.
Adheres to the proper handling of chemically hazardous goods.
Interfaces with process automation and electronic business systems.
Supports, and may lead, the revisions of SOPs and BPRs.
Supports, and may lead, qualifications and validation activities, as assigned.
In collaboration with Bioprocessing leadership, recognizes, troubleshoots, and initiates deviations for process issues of moderate scope.
Supports team effort in the effective and timely completion of root cause investigations and CAPA implementation.
Provides continuous training of other team members on standard roles as needed.
Ensures Humacyte or other required trainings/certifications are up to date.
Other duties, as assigned.
Special Skills:
Works within clearly defined standard operating procedures (SOPs) and/or scientific methods.
Uses advanced knowledge of cGMP manufacturing, Humacyte’s manufacturing process, analytical skills, and application of scientific methods or operational processes to perform a variety of activities.
Provides recommended solutions and steps for resolution to problems of moderate complexity to leadership.
Identifies areas or situations with greater complexity and partners with the Humacyte MSAT team to ensure appropriate resolution.
Possesses deep and strong technical skills and the ability to translate those technical skills into problem solving and solutions.
Has ability to differentiate between important and less important tasks within own work and act accordingly.
Strong, proactive communicator that is able to interface effectively across multiple departments with support as needed.
Qualifications:
Requires a Bachelor’s Degree, or equivalent on the job experience. Master’s degree or above preferred.
5+ years of previous experience in pharmaceutical, biotechnology, and/or sterile production environments, required.
Strong knowledge of cGMP requirements, required.
Experience executing SOPs and demonstrated thorough and strong documenting work, required.
Moderate to advanced mechanical aptitude or knowledge of electrical / mechanical equipment, preferred.
Previous cell culture experience, highly preferred.
Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines.
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Excellent communication and interpersonal skills
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross-functional team environment
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
The MSAT Engineer - Analytics will support the development and execution of process analytics, process support, and control strategy activities with limited supervision and guidance. This role will be ~50% process analytics and 50% process engineering support. This role will collaborate effectively with personnel in Manufacturing, Engineering, Process Development, Quality Assurance, and Quality Control utilizing strong communication, and technical expertise to maintain and improve manufacturing operations.
Remote Work Designation : Not Remote
Major Accountabilities:
Provides advanced level support for execution and development of the manufacturing control strategy and Process Analytics program
Acquires, analyses, and reports data trends using graphical and statistical methods and utilizes expertise to make recommendations to next level management based on data analysis
Develops systems and processes for the acquisition and analysis of data trends from process, equipment, and raw materials.
Applies statistical process control techniques to independently develop and implement (following appropriate change control) process specifications, parameters, operating ranges, and action limits.
Supports the execution of commercial manufacturing campaigns
Provides guidance to others on advanced and/or moderately complex theory and concepts behind the process including an understanding of the impact of any process changes or improvements, as well as the impact of any process deviations or drift
Proactively identifies technical issues on bioprocessing equipment and recommends activities to resolve the issue. Implements procedures and activities to prevent the same issue from occurring.
Authors standard operating procedures, reports, and protocols and solicit next level manager approval for final documents
Special Competencies:
Advanced knowledge of statistical process control methods and data interpretation
Knowledge of multivariate modeling techniques
Familiarity with data engineering concept for collection, storage, and validation of data
Demonstrated technical foundation of cell- and tissue- based products and a strong familiarity with GMP manufacturing
Able to independently troubleshoot advanced or moderately complex bioprocess activities and perform typical and atypical bioprocess optimization studies
Possesses advanced knowledge of the cell biological aspects of the process, as well as the engineering and mass-transfer aspects of the process
Possesses understanding and demonstrated knowledge of equipment and procedures and identifies potential problem before they occur
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross functional team
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Always observe safety precautions and regulations in all areas where duties are performed
Responsible for reporting all safety hazards and potential unsafe working conditions
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Qualifications:
BS in Engineering or other relevant discipline required.
MS in related discipline preferred.
Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell therapy, tissue engineering, regenerative medicine, or process development required.
Minimum of 2 years of commercial manufacturing or Phase 3 CDMO or 6 years Phase 1-3 clinical manufacturing experience required.
Demonstrated experience with the Process Validation Lifecycle and Statistical Process Control methods
Experience with application of analytical systems and computational methods to biological systems in a GMP environment
Demonstrated experience leading basic troubleshooting and participating in complex troubleshooting/
Possess a demonstrated technical foundation of cell- and tissue- based products.
Experience with bioprocessing deviations, change control, process optimization, and technical troubleshooting.
Works well in a team environment.
Strong experience working cross functionally within a BioPharma Bioprocessing organization.
Apr 24, 2024
Full time
The MSAT Engineer - Analytics will support the development and execution of process analytics, process support, and control strategy activities with limited supervision and guidance. This role will be ~50% process analytics and 50% process engineering support. This role will collaborate effectively with personnel in Manufacturing, Engineering, Process Development, Quality Assurance, and Quality Control utilizing strong communication, and technical expertise to maintain and improve manufacturing operations.
Remote Work Designation : Not Remote
Major Accountabilities:
Provides advanced level support for execution and development of the manufacturing control strategy and Process Analytics program
Acquires, analyses, and reports data trends using graphical and statistical methods and utilizes expertise to make recommendations to next level management based on data analysis
Develops systems and processes for the acquisition and analysis of data trends from process, equipment, and raw materials.
Applies statistical process control techniques to independently develop and implement (following appropriate change control) process specifications, parameters, operating ranges, and action limits.
Supports the execution of commercial manufacturing campaigns
Provides guidance to others on advanced and/or moderately complex theory and concepts behind the process including an understanding of the impact of any process changes or improvements, as well as the impact of any process deviations or drift
Proactively identifies technical issues on bioprocessing equipment and recommends activities to resolve the issue. Implements procedures and activities to prevent the same issue from occurring.
Authors standard operating procedures, reports, and protocols and solicit next level manager approval for final documents
Special Competencies:
Advanced knowledge of statistical process control methods and data interpretation
Knowledge of multivariate modeling techniques
Familiarity with data engineering concept for collection, storage, and validation of data
Demonstrated technical foundation of cell- and tissue- based products and a strong familiarity with GMP manufacturing
Able to independently troubleshoot advanced or moderately complex bioprocess activities and perform typical and atypical bioprocess optimization studies
Possesses advanced knowledge of the cell biological aspects of the process, as well as the engineering and mass-transfer aspects of the process
Possesses understanding and demonstrated knowledge of equipment and procedures and identifies potential problem before they occur
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross functional team
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Always observe safety precautions and regulations in all areas where duties are performed
Responsible for reporting all safety hazards and potential unsafe working conditions
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Qualifications:
BS in Engineering or other relevant discipline required.
MS in related discipline preferred.
Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell therapy, tissue engineering, regenerative medicine, or process development required.
Minimum of 2 years of commercial manufacturing or Phase 3 CDMO or 6 years Phase 1-3 clinical manufacturing experience required.
Demonstrated experience with the Process Validation Lifecycle and Statistical Process Control methods
Experience with application of analytical systems and computational methods to biological systems in a GMP environment
Demonstrated experience leading basic troubleshooting and participating in complex troubleshooting/
Possess a demonstrated technical foundation of cell- and tissue- based products.
Experience with bioprocessing deviations, change control, process optimization, and technical troubleshooting.
Works well in a team environment.
Strong experience working cross functionally within a BioPharma Bioprocessing organization.
Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is also focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.
We are looking for additional colleagues to continue to build our expanding team. Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.
Position Background:
We are searching for a Manager, Regulatory Affairs Labeling and Operations with a solutions oriented, roll-up-your-sleeves, attitude to join the Regulatory Affairs team, collaborate cross-functionally and externally with vendors. The individual for this position will be responsible for the compilation of labeling documents for all submissions which include labeling information to market Humacyte’s Human Acellular Vessel (HAV) in the US and worldwide. This position will also be accountable for completing tasks in regulatory operations.
Remote Work Designation : Onsite/Not Remote
Major Accountabilities:
This individual will be responsible for working closely with the scientific, regulatory, medical, and commercial/marketing functions to generate, proof-read, and manage versions of labeling documents.
Liaison with Regulatory, CMC, Marketing, Operations and Sales to manage changing properties to support labeling change projects including launches, promotions and packaging updates.
Manage advertising and marketing material changes to ensure accuracy and regulatory compliance.
Prepare and support regulatory submissions for product development, approvals and renewals for FDA and EMA.
Support regulatory submission of promotional materials.
Work closely with external vendors for timely generation, and review of SPL label format for labeling submissions.
This position may also support efforts within the company to improve labeling processes e.g., drafting of relevant SOPs, work instructions, generating templates etc.
Qualifications:
Requires a Bachelor’s degree, or equivalent on the job experience.
Six years of Regulatory Affairs work experience is required.
Minimum of 4 years of direct hand-on experience with global labeling document required, with US focus. Global experience preferred.
Experience working with Regulatory Operations required.
Proficient in working with the Electronic Common Technical Document (eCTD) and regulatory document management systems.
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Excellent communication and interpersonal skills
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross-functional team environment
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Apr 24, 2024
Full time
Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is also focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.
We are looking for additional colleagues to continue to build our expanding team. Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.
Position Background:
We are searching for a Manager, Regulatory Affairs Labeling and Operations with a solutions oriented, roll-up-your-sleeves, attitude to join the Regulatory Affairs team, collaborate cross-functionally and externally with vendors. The individual for this position will be responsible for the compilation of labeling documents for all submissions which include labeling information to market Humacyte’s Human Acellular Vessel (HAV) in the US and worldwide. This position will also be accountable for completing tasks in regulatory operations.
Remote Work Designation : Onsite/Not Remote
Major Accountabilities:
This individual will be responsible for working closely with the scientific, regulatory, medical, and commercial/marketing functions to generate, proof-read, and manage versions of labeling documents.
Liaison with Regulatory, CMC, Marketing, Operations and Sales to manage changing properties to support labeling change projects including launches, promotions and packaging updates.
Manage advertising and marketing material changes to ensure accuracy and regulatory compliance.
Prepare and support regulatory submissions for product development, approvals and renewals for FDA and EMA.
Support regulatory submission of promotional materials.
Work closely with external vendors for timely generation, and review of SPL label format for labeling submissions.
This position may also support efforts within the company to improve labeling processes e.g., drafting of relevant SOPs, work instructions, generating templates etc.
Qualifications:
Requires a Bachelor’s degree, or equivalent on the job experience.
Six years of Regulatory Affairs work experience is required.
Minimum of 4 years of direct hand-on experience with global labeling document required, with US focus. Global experience preferred.
Experience working with Regulatory Operations required.
Proficient in working with the Electronic Common Technical Document (eCTD) and regulatory document management systems.
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Excellent communication and interpersonal skills
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross-functional team environment
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Position Background:
The Automation Engineer 2 is responsible for supporting any existing and new project automation systems at Humacyte, an FDA regulated site. This includes daily verifications required for data integrity requirements and modifications to the system configuration as required for process, building or historian automation requirements. There is an expectation that the employee will have a primary system responsibility, either DeltaV, PLC, BAS, or PI focused, but will be able to support all automation system as required .
Remote Work Designation : Not Remote
Major Accountabilities:
Utilizing current engineering skills and knowledge, provide routine automation expertise for the development of custom commercial manufacturing equipment for a human acellular vessel product with the guidance and direction of more senior team members and/or manager
Support and maintain existing PI data historian in existing manufacturing and R&D facilities
In collaboration with Senior Automation Engineer and/or Associate Director, Automation, support the installation and validation of a PI data historian for the commercial manufacturing facility
Support the installation and validation of a DeltaV system for the commercial manufacturing process
Support the installation and validation a building automation system for the commercial manufacturing facility
Support the installation and validation of OEM and custom PLCs for the commercial manufacturing process
Assist process development team in testing prototype equipment and by independently developing automation for custom research and development equipment
Promote transparency around process development activities through routine internal updates to direct manager and/or cross-functional colleagues
Support and troubleshooting automation during development, technology transfer, and commercial manufacturing
Perform thorough system tests to ensure robustness of custom automation
Assist in oversight in transition of automated equipment to comply with regulatory and quality control requirements
Assist in the development of automation documentation, including functional requirements, design documents, test protocols, SOPs and reports
Respond to automation-based alarms during standard office hours and as on-call support, as required
Support regulatory filings as required
Other duties, as assigned
Special Competencies:
Demonstrated knowledge and understanding of developing and supporting automation for commercial manufacturing processes
Familiarity with automation of bioprocess applications in GMP facility
Familiarity and understanding of basic and/or advanced cGMP compliance in the biotech/bioprocessing manufacturing environment
Knowledge of Code of Federal Regulations 21 CFR 1271 a plus
Detail-oriented, self-motivated and scientifically driven
Strong analytical and problem-solving skills
Strong knowledge of GMP quality systems
Excellent communication and interpersonal skills
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Excellent communication and interpersonal skills
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross functional team
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Always observe safety precautions and regulations in all areas where duties are performed
Responsible for reporting all safety hazards and potential unsafe working conditions
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Qualifications:
BS in Mechanical Engineering, Electrical Engineering, Chemical Engineering, or similar field, required
At least 3 years of industry experience in process and equipment automation
At least 3 years of relevant pharma or biotech industry experience
Experience with automation platforms including Allen-Bradley PLC, DeltaV DCS, Beckhoff TwinCAT PLC and/or Johnson Controls
Experience installing and/or supporting PI historian system
Background in Automation, Electrical Engineering or Mechanical Engineering
Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment
Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines
Apr 24, 2024
Full time
Position Background:
The Automation Engineer 2 is responsible for supporting any existing and new project automation systems at Humacyte, an FDA regulated site. This includes daily verifications required for data integrity requirements and modifications to the system configuration as required for process, building or historian automation requirements. There is an expectation that the employee will have a primary system responsibility, either DeltaV, PLC, BAS, or PI focused, but will be able to support all automation system as required .
Remote Work Designation : Not Remote
Major Accountabilities:
Utilizing current engineering skills and knowledge, provide routine automation expertise for the development of custom commercial manufacturing equipment for a human acellular vessel product with the guidance and direction of more senior team members and/or manager
Support and maintain existing PI data historian in existing manufacturing and R&D facilities
In collaboration with Senior Automation Engineer and/or Associate Director, Automation, support the installation and validation of a PI data historian for the commercial manufacturing facility
Support the installation and validation of a DeltaV system for the commercial manufacturing process
Support the installation and validation a building automation system for the commercial manufacturing facility
Support the installation and validation of OEM and custom PLCs for the commercial manufacturing process
Assist process development team in testing prototype equipment and by independently developing automation for custom research and development equipment
Promote transparency around process development activities through routine internal updates to direct manager and/or cross-functional colleagues
Support and troubleshooting automation during development, technology transfer, and commercial manufacturing
Perform thorough system tests to ensure robustness of custom automation
Assist in oversight in transition of automated equipment to comply with regulatory and quality control requirements
Assist in the development of automation documentation, including functional requirements, design documents, test protocols, SOPs and reports
Respond to automation-based alarms during standard office hours and as on-call support, as required
Support regulatory filings as required
Other duties, as assigned
Special Competencies:
Demonstrated knowledge and understanding of developing and supporting automation for commercial manufacturing processes
Familiarity with automation of bioprocess applications in GMP facility
Familiarity and understanding of basic and/or advanced cGMP compliance in the biotech/bioprocessing manufacturing environment
Knowledge of Code of Federal Regulations 21 CFR 1271 a plus
Detail-oriented, self-motivated and scientifically driven
Strong analytical and problem-solving skills
Strong knowledge of GMP quality systems
Excellent communication and interpersonal skills
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Excellent communication and interpersonal skills
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross functional team
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Always observe safety precautions and regulations in all areas where duties are performed
Responsible for reporting all safety hazards and potential unsafe working conditions
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Qualifications:
BS in Mechanical Engineering, Electrical Engineering, Chemical Engineering, or similar field, required
At least 3 years of industry experience in process and equipment automation
At least 3 years of relevant pharma or biotech industry experience
Experience with automation platforms including Allen-Bradley PLC, DeltaV DCS, Beckhoff TwinCAT PLC and/or Johnson Controls
Experience installing and/or supporting PI historian system
Background in Automation, Electrical Engineering or Mechanical Engineering
Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment
Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines
Developmental Therapy Associates
Raleigh (27615) and Durham (27707) NC
Definition of Front Desk Coordinator at DTA: This position is defined as the person at a particular clinic location that coordinates needed for that office and reports directly to the Front Desk Manager. This is a very busy position that involves coordination of several administrative duties including, but not limited to, scheduling, in-clinic collections, insurance verifications, continued insurance authorizations and is often the first face of DTA to our community!
Purpose: To oversee the Front Desk of the company, to assist with the production and viability of the whole group.
Product: High volume of kept patient appointments to an efficiently structured schedule with full patient billing information turned over to the Billing Department.
This post includes the following functions:
Ensuring the internal and external communications of the company flow smoothly and efficiently.
Keeping a good working relationship with all referral sources, both new and existing
Overseeing the setting of patient appointments efficiently and for maximum production.
Ensuring that appointments by patients are kept. This includes rescheduling within the same week when possible
Enforcing DTA Arrivals Policy (“No show” and 24-hour cancellation policies)
Ensuring referrals convert into evaluations with minimal delay.
Tracking referrals
Completing insurance authorizations and re-authorizations on time to prevent lapse in therapy services.
Ensuring all services provided have full billing information obtained before service is rendered.
Ensuring front desk collections are done fully and on time (same day of service).
Assisting with marketing and public relations duties as needed which may include:
Maintain the reception area, keeping it clean and free of clutter
Maintain an orderly & clean waiting area
Ensure it is clean, chairs put away, etc.
Quotas:
86% or better arrival rate
5+ initial evaluations per week
Five 5-star reviews each month from clients
Job Skills and Qualifications:
Required:
This is a very important position within our organization. Must have a high communication level, excellent control, and enjoy working with others with a ready smile and pleasantness. Prediction of schedules and promises is critical, so it is up to you to stay on top of everything. Must keep great PR with our public, in person or over the phone or via mail.
High school diploma or GED
At least two years of training or experience in customer service and office work
Computer (PC) proficiency
Strong verbal and written communication skills
Ability to work independently
Preferred:
College degree in business administration or equivalent
Schedule: This position is Full-time 8:30 AM - 5:30 PM or 9 AM - 6 PM with 1-hour lunch breaks
***Attendance is very crucial in this position, so all time-off and lateness must be worked out beforehand when possible.***
Benefits:
401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance
Salary: $30,000.00 - $40,000.00 per year
Apr 22, 2024
Full time
Definition of Front Desk Coordinator at DTA: This position is defined as the person at a particular clinic location that coordinates needed for that office and reports directly to the Front Desk Manager. This is a very busy position that involves coordination of several administrative duties including, but not limited to, scheduling, in-clinic collections, insurance verifications, continued insurance authorizations and is often the first face of DTA to our community!
Purpose: To oversee the Front Desk of the company, to assist with the production and viability of the whole group.
Product: High volume of kept patient appointments to an efficiently structured schedule with full patient billing information turned over to the Billing Department.
This post includes the following functions:
Ensuring the internal and external communications of the company flow smoothly and efficiently.
Keeping a good working relationship with all referral sources, both new and existing
Overseeing the setting of patient appointments efficiently and for maximum production.
Ensuring that appointments by patients are kept. This includes rescheduling within the same week when possible
Enforcing DTA Arrivals Policy (“No show” and 24-hour cancellation policies)
Ensuring referrals convert into evaluations with minimal delay.
Tracking referrals
Completing insurance authorizations and re-authorizations on time to prevent lapse in therapy services.
Ensuring all services provided have full billing information obtained before service is rendered.
Ensuring front desk collections are done fully and on time (same day of service).
Assisting with marketing and public relations duties as needed which may include:
Maintain the reception area, keeping it clean and free of clutter
Maintain an orderly & clean waiting area
Ensure it is clean, chairs put away, etc.
Quotas:
86% or better arrival rate
5+ initial evaluations per week
Five 5-star reviews each month from clients
Job Skills and Qualifications:
Required:
This is a very important position within our organization. Must have a high communication level, excellent control, and enjoy working with others with a ready smile and pleasantness. Prediction of schedules and promises is critical, so it is up to you to stay on top of everything. Must keep great PR with our public, in person or over the phone or via mail.
High school diploma or GED
At least two years of training or experience in customer service and office work
Computer (PC) proficiency
Strong verbal and written communication skills
Ability to work independently
Preferred:
College degree in business administration or equivalent
Schedule: This position is Full-time 8:30 AM - 5:30 PM or 9 AM - 6 PM with 1-hour lunch breaks
***Attendance is very crucial in this position, so all time-off and lateness must be worked out beforehand when possible.***
Benefits:
401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance
Salary: $30,000.00 - $40,000.00 per year
New York Life Insurance Company
Charlotte, NC 28277, USA
Partner with us and see your career grow with New York Life Charlotte General Office!
Are you ready to launch a career and not settle for just another job? Do you see yourself running your own business complete with all the challenges, financial rewards, and personal satisfaction that such an enterprise can bring? If so, you owe it to yourself to consider a career with New York Life Insurance Company as your partner.
We are looking for motivated self-starters who would like to:
Manage their own work schedule and establish an attractive work/life balance.
Build their career with significant income potential.
Grow their business supported by the financial strength and integrity of New York Life.
Make a difference in their community by helping others achieve financial peace of mind.
Customize their career path to match their personal financial goals.
Experience a lifetime of learning and professional development.
Enjoy recognition and rewards for their financial achievements.
Define their career path as a Financial Services agent and have the opportunity for management.
Qualifications:
Organized, detail-oriented, and excellent time management skills.
Strong sales, leadership, and communication skills.
Ability to work in a team-based environment.
College Degree preferred.
Sales experience preferred.
Highly self-motivated and self-disciplined.
Relationship building and networking abilities.
FINRA Series 6/63, Series 7 - not required.
Financial Industry background is a plus
Here's what you'll do:
Build relationships with clients beyond a financial/transactional basis.
Develop your professional skills and sales knowledge.
Develop and implement business and marketing plans.
Prospect for potential clients.
Schedule appointments and meet with clients.
Discuss financial concerns and needs of individuals.
Present potential solutions using our world class suite of products and services.
Provide ongoing support to existing clients.
Benefits:
Health/Dental/Life/Disability
401 (k) plan after one year of service and Pension Plan
Continuing education reimbursement
Reimbursement for industry designations
Training:
NYLIC University: One of the most comprehensive and well-respected training programs in the industry.
Company Description:
New York Life, a Fortune 100 company created in 1845, is one of the most respected and successful companies in America and internationally. Headquartered in New York City, New York Life's family of companies offers life insurance, retirement income products, and long-term care insurance. New York Life Investment Management LLC provides institutional asset management and retirement plan services. Other New York Life affiliates provide an array of securities products and services, as well as institutional and retail mutual funds.
EOE M/F/D/V 1611768
New York Life Charlotte General Office
Apr 22, 2024
Full time
Partner with us and see your career grow with New York Life Charlotte General Office!
Are you ready to launch a career and not settle for just another job? Do you see yourself running your own business complete with all the challenges, financial rewards, and personal satisfaction that such an enterprise can bring? If so, you owe it to yourself to consider a career with New York Life Insurance Company as your partner.
We are looking for motivated self-starters who would like to:
Manage their own work schedule and establish an attractive work/life balance.
Build their career with significant income potential.
Grow their business supported by the financial strength and integrity of New York Life.
Make a difference in their community by helping others achieve financial peace of mind.
Customize their career path to match their personal financial goals.
Experience a lifetime of learning and professional development.
Enjoy recognition and rewards for their financial achievements.
Define their career path as a Financial Services agent and have the opportunity for management.
Qualifications:
Organized, detail-oriented, and excellent time management skills.
Strong sales, leadership, and communication skills.
Ability to work in a team-based environment.
College Degree preferred.
Sales experience preferred.
Highly self-motivated and self-disciplined.
Relationship building and networking abilities.
FINRA Series 6/63, Series 7 - not required.
Financial Industry background is a plus
Here's what you'll do:
Build relationships with clients beyond a financial/transactional basis.
Develop your professional skills and sales knowledge.
Develop and implement business and marketing plans.
Prospect for potential clients.
Schedule appointments and meet with clients.
Discuss financial concerns and needs of individuals.
Present potential solutions using our world class suite of products and services.
Provide ongoing support to existing clients.
Benefits:
Health/Dental/Life/Disability
401 (k) plan after one year of service and Pension Plan
Continuing education reimbursement
Reimbursement for industry designations
Training:
NYLIC University: One of the most comprehensive and well-respected training programs in the industry.
Company Description:
New York Life, a Fortune 100 company created in 1845, is one of the most respected and successful companies in America and internationally. Headquartered in New York City, New York Life's family of companies offers life insurance, retirement income products, and long-term care insurance. New York Life Investment Management LLC provides institutional asset management and retirement plan services. Other New York Life affiliates provide an array of securities products and services, as well as institutional and retail mutual funds.
EOE M/F/D/V 1611768
New York Life Charlotte General Office
Essential duties and functions, pursuant to the Americans with Disabilities Act, may include the following. Other related duties may be assigned.
Operates and checks a variety of powered and non-powered equipment including, but not limited to, backhoe, bobcat, weed-eater, vacuum cleaner, buffer, lawn mower, rider mower, and front-end loader. Adjusts equipment, including chemical feed, as directed.
Cleans and maintains equipment and facilities.
Assists plant operation and maintenance technicians to perform mechanical maintenance tasks.
Assists, under direction of licensed operator, with process control tasks such as a basic flow control, sampling, basic laboratory testing, normal operations of pumps and blowers, and adjusting chemical feeds.
Handles a variety of hazardous and non-hazardous solvents and chemicals.
Reads and interprets simple drawings and diagrams.
Reads gauges and meters.
Maintains records, enters and retrieves data using CMMS software.
May act as member of confined space team and serve as entrant or assistant.
Apr 22, 2024
Full time
Essential duties and functions, pursuant to the Americans with Disabilities Act, may include the following. Other related duties may be assigned.
Operates and checks a variety of powered and non-powered equipment including, but not limited to, backhoe, bobcat, weed-eater, vacuum cleaner, buffer, lawn mower, rider mower, and front-end loader. Adjusts equipment, including chemical feed, as directed.
Cleans and maintains equipment and facilities.
Assists plant operation and maintenance technicians to perform mechanical maintenance tasks.
Assists, under direction of licensed operator, with process control tasks such as a basic flow control, sampling, basic laboratory testing, normal operations of pumps and blowers, and adjusting chemical feeds.
Handles a variety of hazardous and non-hazardous solvents and chemicals.
Reads and interprets simple drawings and diagrams.
Reads gauges and meters.
Maintains records, enters and retrieves data using CMMS software.
May act as member of confined space team and serve as entrant or assistant.
If you are looking for a dynamic work environment in a fast growing organization where you can make a difference, AnalytiChem might be the challenge you are seeking.We are looking for Inside Sales Manager that will be capable of handling multiple projects simultaneously and possess an adaptable personality. This candidate must have a high sense of urgency to give clients a positive experience and achieve individual and company goals. We are looking for 2 Inside Sales Managers!
Your main responsibilities:
Work on a sales team within the AnalytiChem North America group.
Understand the overall sales process, CRM system and procedures.
Establish, secure and grow relationships with assigned accounts in a specific geography.
Develop solutions to meet the needs of assigned accounts.
Develop & create new opportunities from assigned accounts.
Develop & execute business plans focused on specific account projects or industry segments.
Respond to specific RFPs or formal proposals as required. Monitor status and execute on won bids as needed.
Provide quotes, proposals and presentations to assigned accounts for specific opportunities as needed.
Travel to assigned account(s) locations as needed for client presentations and team sales meetings.
Support and assist with new business development activities as assigned to the sales team.
Other duties as assigned by the North America sales team.
Apr 22, 2024
Full time
If you are looking for a dynamic work environment in a fast growing organization where you can make a difference, AnalytiChem might be the challenge you are seeking.We are looking for Inside Sales Manager that will be capable of handling multiple projects simultaneously and possess an adaptable personality. This candidate must have a high sense of urgency to give clients a positive experience and achieve individual and company goals. We are looking for 2 Inside Sales Managers!
Your main responsibilities:
Work on a sales team within the AnalytiChem North America group.
Understand the overall sales process, CRM system and procedures.
Establish, secure and grow relationships with assigned accounts in a specific geography.
Develop solutions to meet the needs of assigned accounts.
Develop & create new opportunities from assigned accounts.
Develop & execute business plans focused on specific account projects or industry segments.
Respond to specific RFPs or formal proposals as required. Monitor status and execute on won bids as needed.
Provide quotes, proposals and presentations to assigned accounts for specific opportunities as needed.
Travel to assigned account(s) locations as needed for client presentations and team sales meetings.
Support and assist with new business development activities as assigned to the sales team.
Other duties as assigned by the North America sales team.
Matchbook Learning
Philadelphia (different areas of the city)
Special Education Assistant: Assists students with various needs including behavioral needs, severe medical and/or mobility needs, who are medically fragile, and/or students with disabilities receiving special education services. Provides support and assistance to help students access the instructional program in school and community settings. Maintains a safe educational environment for students with activities of daily living, monitoring health and behavior.
Bus Driver: Operates a school bus for the School District of Philadelphia. Provides transportation to students, on regularly scheduled route, to and from school, to alternate sites during the school day and after school hours, and on school-sponsored field trips. Provides transportation to School District employees from and to selected work sites. Performs minor daily preventative maintenance to the vehicle as needed.
Building Engineer: Under the general supervision of the Facilities Area Coordinator is responsible for the operation, maintenance and security of the school plant to which assigned, both buildings and grounds. Supports the coordinated requirements of the principal, staff and cafeteria personnel. Performs services generally in an elementary school, (with some exceptions) with a buildings area greater than 100,000 square feet.
School Nurses: Performs general duty nursing work. Provides comprehensive health assessments and problem management services to students in public, private and parochial schools for one or for a cluster of schools. Manages the school health program and maintains comprehensive health records for each student. Provides health counseling to students, parents and school personnel on issues designed to promote good health habits in students. Collaborates with school personnel and service providers in the community to meet individual student ’ s needs.
Custodial Assistants: Performs manual work of ordinary difficulty in cleaning and maintaining School District buildings and immediate grounds. Performs minor repairs on furniture and equipment, as well as uses power equipment to care for the grounds.
Bus Attendants: Monitors the activities of special education students while on buses in route to and from school. Maintains order and discipline on the bus to provide for the safe and secure transportation of students as well as ensuring that students board and leave buses in a safe and orderly fashion. Renders necessary basic first aid or other assistance to ensure the student’s well-being and safety. Provides routine assistance with receiving, logging, storing and issuing supplies and materials.
Supportive Service Assistant: Assists teaching and non-teaching staff in schools within the Title I program. Participates in a cooperative effort to support basic skills achievement of students who are economically or educationally disadvantage. Provides instructional assistance in the classrooms in major subject areas which include reading and mathematics and/or facilitative services to non-instructional staff in support of the program's overall objectives. Assists teachers in the preparation of and during instructional activities, and addresses the tutorial needs of students as identified. Assists staff in the development of parent workshops.
Apr 22, 2024
Full time
Special Education Assistant: Assists students with various needs including behavioral needs, severe medical and/or mobility needs, who are medically fragile, and/or students with disabilities receiving special education services. Provides support and assistance to help students access the instructional program in school and community settings. Maintains a safe educational environment for students with activities of daily living, monitoring health and behavior.
Bus Driver: Operates a school bus for the School District of Philadelphia. Provides transportation to students, on regularly scheduled route, to and from school, to alternate sites during the school day and after school hours, and on school-sponsored field trips. Provides transportation to School District employees from and to selected work sites. Performs minor daily preventative maintenance to the vehicle as needed.
Building Engineer: Under the general supervision of the Facilities Area Coordinator is responsible for the operation, maintenance and security of the school plant to which assigned, both buildings and grounds. Supports the coordinated requirements of the principal, staff and cafeteria personnel. Performs services generally in an elementary school, (with some exceptions) with a buildings area greater than 100,000 square feet.
School Nurses: Performs general duty nursing work. Provides comprehensive health assessments and problem management services to students in public, private and parochial schools for one or for a cluster of schools. Manages the school health program and maintains comprehensive health records for each student. Provides health counseling to students, parents and school personnel on issues designed to promote good health habits in students. Collaborates with school personnel and service providers in the community to meet individual student ’ s needs.
Custodial Assistants: Performs manual work of ordinary difficulty in cleaning and maintaining School District buildings and immediate grounds. Performs minor repairs on furniture and equipment, as well as uses power equipment to care for the grounds.
Bus Attendants: Monitors the activities of special education students while on buses in route to and from school. Maintains order and discipline on the bus to provide for the safe and secure transportation of students as well as ensuring that students board and leave buses in a safe and orderly fashion. Renders necessary basic first aid or other assistance to ensure the student’s well-being and safety. Provides routine assistance with receiving, logging, storing and issuing supplies and materials.
Supportive Service Assistant: Assists teaching and non-teaching staff in schools within the Title I program. Participates in a cooperative effort to support basic skills achievement of students who are economically or educationally disadvantage. Provides instructional assistance in the classrooms in major subject areas which include reading and mathematics and/or facilitative services to non-instructional staff in support of the program's overall objectives. Assists teachers in the preparation of and during instructional activities, and addresses the tutorial needs of students as identified. Assists staff in the development of parent workshops.
As a Matchbook Learning teacher, you will be a teacher, a project advisor and a learning facilitator. Matchbook teachers provide targeted small-group instruction, lead whole group discussions, coach students as they work with individualized online learning tools, and collaborate with peers to ensure high levels of student achievement. Matchbook provides teachers with research based virtual platforms which we believe are a key to both student and teacher success. We believe that ordinary teachers can achieve extraordinary results when their development is personalized and empowered with the aid of technology.
Apr 22, 2024
Full time
As a Matchbook Learning teacher, you will be a teacher, a project advisor and a learning facilitator. Matchbook teachers provide targeted small-group instruction, lead whole group discussions, coach students as they work with individualized online learning tools, and collaborate with peers to ensure high levels of student achievement. Matchbook provides teachers with research based virtual platforms which we believe are a key to both student and teacher success. We believe that ordinary teachers can achieve extraordinary results when their development is personalized and empowered with the aid of technology.
M3 Engineering & Technology
Charlotte, NC 28226, USA
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
Apr 18, 2024
Full time
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
M3 Engineering & Technology
Charlotte, NC 28226, USA
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
Apr 18, 2024
Full time
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
M3 Engineering & Technology
Charlotte, NC 28226, USA
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
Apr 18, 2024
Full time
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
M3 Engineering & Technology
Charlotte, NC 28226, USA
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
Apr 18, 2024
Full time
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
M3 Engineering & Technology
Charlotte, NC 28226, USA
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
Apr 18, 2024
Full time
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
M3 Engineering & Technology
Charlotte, NC 28226, USA
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
Apr 18, 2024
Full time
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
M3 Engineering & Technology
Charlotte, NC 28226, USA
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
Apr 18, 2024
Full time
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
NEEDS Center
Roxbury, Boston, Roxbury, MA 02119, USA
COME GROW WITH US! The NEEDS Center has an opening for a BCBA who will ensure the quality of school based services by directing the clinical services and programs for children with developmental disabilities with a focus on Autism Spectrum Disorders in the Boston, MA area. This is a full-time opportunity!
Responsibilities include :
Develop and monitor individualized treatment plans and behavior support plans for assigned caseload
Conduct initial and ongoing assessments and write progress reports
Provide instruction, support, and feedback to Direct Support staff with regard to managing challenging behaviors and teaching replacement behaviors
Conduct Functional Assessments and Functional Analysis for all challenging behaviors
Review program effectiveness, make recommendations, monitor data collection, and chart progress
Qualifications :
A minimum of a Master's Degree in a related field
A current BCBA Certification/License preferred but will consider candidates who are BCBA eligible
A minimum of 3 years of experience working in a setting that utilizes programming based on the principles of applied behavior analysis
Experience with the following: completing functional behavior assessments, authoring behavior support plans, creating program materials, providing training and supervising direct services to individuals
Experience working with individuals diagnosed with Autism Spectrum Disorder required
Good communication skills, both written and verbal
Must have a valid driver’s license
Macintosh and PC literacy required as well as experience with program related software including, Excel, Word, etc.
The NEEDS Center specializes in providing services and support to individuals with developmental disabilities, including Autism Spectrum Disorder (ASD). There is a particular emphasis on providing services to individuals with interfering challenging behavior and/or dual diagnosis. The NEEDS Center’s philosophy is rooted in the tenets of Applied Behavior Analysis (ABA), and Positive Behavior Support (PSB). The services and supports provided by the NEEDS Center draw on the best of both disciplines in order to assist individuals to become as independent as they can be. Our primary coverage area is the northeast region of Massachusetts.
Benefits Include :
Health insurance
Dental, Vision, FSA, 403b
Generous PTO (time is fronted after 30 days ) and your birthday off
Tuition Reimbursement
Mileage Reimbursement
Company iPhone, iPad, and laptop all provided
Professional liability insurance
Financial support on professional license and certification renewal
Free access to our on-demand training library with opportunity to earn CEU’s
Clinically supportive environment with regular opportunities to meet and collaborate with NEEDS Center BCBA’s and supervisors
Job Type: Full-time
Salary: $100,000.00 per year
Apr 15, 2024
Full time
COME GROW WITH US! The NEEDS Center has an opening for a BCBA who will ensure the quality of school based services by directing the clinical services and programs for children with developmental disabilities with a focus on Autism Spectrum Disorders in the Boston, MA area. This is a full-time opportunity!
Responsibilities include :
Develop and monitor individualized treatment plans and behavior support plans for assigned caseload
Conduct initial and ongoing assessments and write progress reports
Provide instruction, support, and feedback to Direct Support staff with regard to managing challenging behaviors and teaching replacement behaviors
Conduct Functional Assessments and Functional Analysis for all challenging behaviors
Review program effectiveness, make recommendations, monitor data collection, and chart progress
Qualifications :
A minimum of a Master's Degree in a related field
A current BCBA Certification/License preferred but will consider candidates who are BCBA eligible
A minimum of 3 years of experience working in a setting that utilizes programming based on the principles of applied behavior analysis
Experience with the following: completing functional behavior assessments, authoring behavior support plans, creating program materials, providing training and supervising direct services to individuals
Experience working with individuals diagnosed with Autism Spectrum Disorder required
Good communication skills, both written and verbal
Must have a valid driver’s license
Macintosh and PC literacy required as well as experience with program related software including, Excel, Word, etc.
The NEEDS Center specializes in providing services and support to individuals with developmental disabilities, including Autism Spectrum Disorder (ASD). There is a particular emphasis on providing services to individuals with interfering challenging behavior and/or dual diagnosis. The NEEDS Center’s philosophy is rooted in the tenets of Applied Behavior Analysis (ABA), and Positive Behavior Support (PSB). The services and supports provided by the NEEDS Center draw on the best of both disciplines in order to assist individuals to become as independent as they can be. Our primary coverage area is the northeast region of Massachusetts.
Benefits Include :
Health insurance
Dental, Vision, FSA, 403b
Generous PTO (time is fronted after 30 days ) and your birthday off
Tuition Reimbursement
Mileage Reimbursement
Company iPhone, iPad, and laptop all provided
Professional liability insurance
Financial support on professional license and certification renewal
Free access to our on-demand training library with opportunity to earn CEU’s
Clinically supportive environment with regular opportunities to meet and collaborate with NEEDS Center BCBA’s and supervisors
Job Type: Full-time
Salary: $100,000.00 per year
Clear Channel Outdoor Dallas-Fort Worth
3700 E Randol Mill Rd, Arlington, TX 76011, USA
Meets and exceeds sales goals selling our outstanding inventory to qualified advertisers by developing new business through direct to customer outreach and high-level agency contacts. Develops long-term advertising relationships by presenting comprehensive proposals and competitive & profitable pricing structures.
Job Responsibilities
Drives for revenue goal attainment on a monthly, quarterly, and annual basis.
Prospects and develops new customer relationships, persuasively communicates strategies for meeting customer needs.
Ensures customer satisfaction by facilitating all aspects of the customer's account in cooperation with creative, operations, marketing, and finance staff.
Determines project pricing based on guidelines from management.
Negotiates fees or services with clients with management approval.
Oversees project from start to finish and ensures client satisfaction.
Delivers proof of performance (POP) to clients.
Accompanies clients on market tours to showcase outdoor inventory.
Communicates and coordinates with Ad Ops and other internal departments.
Completes other duties as assigned or requested.
Job title you are hiring for: Account Executive
Apr 15, 2024
Full time
Meets and exceeds sales goals selling our outstanding inventory to qualified advertisers by developing new business through direct to customer outreach and high-level agency contacts. Develops long-term advertising relationships by presenting comprehensive proposals and competitive & profitable pricing structures.
Job Responsibilities
Drives for revenue goal attainment on a monthly, quarterly, and annual basis.
Prospects and develops new customer relationships, persuasively communicates strategies for meeting customer needs.
Ensures customer satisfaction by facilitating all aspects of the customer's account in cooperation with creative, operations, marketing, and finance staff.
Determines project pricing based on guidelines from management.
Negotiates fees or services with clients with management approval.
Oversees project from start to finish and ensures client satisfaction.
Delivers proof of performance (POP) to clients.
Accompanies clients on market tours to showcase outdoor inventory.
Communicates and coordinates with Ad Ops and other internal departments.
Completes other duties as assigned or requested.
Job title you are hiring for: Account Executive