Msat Engineer III

JOB TITLE: MSAT Engineer III

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 HAVs, is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte's 6mm HAV 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 HAV for urgent arterial repair following extremity vascular trauma also has received an RMAT designation. The HAV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.

JOB SUMMARY:

The MSAT Engineer III 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.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Serves as a process expert in HAV production systems and processes

• Lead efforts in troubleshooting out-of-trend manufacturing processes, providing the intellectual, scientific and engineering leadership to identify and implement corrective actions

• Identifies technical issues during bioprocessing and initiates activities to resolve the issue quickly. Identifies and implements procedures to prevent the same issue from occurring.

• Designs and develops continuous improvement opportunities for process robustness and equipment functionality

• Ensures deep understanding of standards of practice, process science and departmental policies through participation in training and development opportunities

• Aids in raw material/single-use material selection, characterization, and implementation.

• Provides comprehensive training and guidance to operations staff

• Partners with Process Development to lead successful process transfers

• Develops and execute test protocols, vendor site visits, FAT/SAT, etc.

• Works with the Validation team to develop and execute validation strategies

EXPERIENCE & 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

• 5 - 8 years of relevant pharma or biotech industry experience, cGMP experience required

• Possess a demonstrated proficiency working in a Process Engineering role with a clear understanding of cGMP manufacturing

• Experience leading projects related to bioprocessing deviations, change control, process optimization, technical troubleshooting, and bioprocessing process changes

• 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

• Strong operating knowledge of feedback control and monitoring of relevant process gasses, nutrients, biological waste products in mammalian cell systems

• Works and leads well in a fast-paced team environment

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.