2 Manufacturing jobs

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