Humacyte Global, Inc.

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

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

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