MSAT Engineer II

DEPARTMENT: MSAT

LOCATION: Durham, NC; Onsite/Not Remote COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass graft, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation. For more information, visit www.Humacyte.com.

JOB SUMMARY:

The MSAT Engineer II is responsible for providing engineering expertise and technical support for Humacyte’s commercial and clinical manufacturing processes. This role serves as a general process engineer for all bioprocessing operations, but specifically this position will focus on manufacturing process support and product lifecycle management activities. With limited supervision, this position will perform support of routine operations, execute engineering studies, troubleshoot technical issues, and lead product life cycle activities such as deviation investigations, CAPA development and implementation, material, process, and product risk assessments, and continuous improvement through change control. This position will collaborate with Manufacturing, Facilities & Engineering, Metrology, Validation, Supply Chain, Quality Assurance, and Product Quality to maintain robust, compliant, and reliable commercial processes.

Responsibilities

• Serves as a process engineer for Acellular Tissue Engineered Vessel (ATEV) production, providing engineering support for GMP manufacturing operations through process monitoring, equipment troubleshooting, and investigation activities
• Leads evaluation and implementation of continuous improvement projects to enhance quality, reliability, and efficiency of the Luna200 manufacturing process
• Develops user requirements, design requirements, risk assessments, extractables and leachables assessments, and technical specifications for equipment and single-use system changes
• Supports selection, qualification, and lifecycle management of product contact materials and suppliers
• Participates in technology transfer, process characterization, process validation, and continued process verification activities
• Partners with Manufacturing and Quality to establish robust procedures and controls for cGMP bioprocessing

Special Competencies

• Demonstrated ability to interpret and apply cGMP requirements, regulatory guidance, and pharmaceutical quality-system principles to technical decision-making, and manufacturing support
• Possesses advanced knowledge of cell- and tissue- based biological processes
• Able to independently troubleshoot commercial scale biological processes, bioprocessing equipment, and execute structured engineering studies
• Familiarity with single-use and reusable bioprocess containers, including bags, bottles, tubing assemblies, connectors, and ports
• Strong ability to work in a fast-paced team environment with fluctuating priorities and demonstrated ability to collaborate within cross functional teams
• Excellent organizational and time management skills with a keen ability to set own priorities in a timely manner
• High degree of flexibility and adaptability

Qualifications

• Bachelor’s Degree in Engineering, Life Sciences or other related technical field, required, or equivalent military training
• 2-5 years working in a GMP regulated environment
• Experience working cross functionally within a Bioprocessing organization
• Experience with single use bioprocessing containers and extractables and leachables considerations in GMP manufacturing
• Experience with current commercial scale bioprocessing technologies and industry practices
• Experience with projects related to process optimization, technical troubleshooting, and bioprocessing equipment changes

COMPENSATION & BENEFITS HIGHLIGHTS:

• Competitive base compensation and bonus
• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• Assortment of other voluntary benefits, including pet insurance; hospital indemnity; accident & critical illness plans; voluntary life insurance; legal protection plans and more
• 23 Days Paid Time Off (PTO) to start
• 10 Company Designated Holidays + 2 Floating Holidays
• Paid Parental Leave Policies

** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters. ** The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.

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