2D Bioprocessing Associate I

Job Description

Job Description

DEPARTMENT : Site Operations

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 grafts, 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 Bioprocessing Associate I participates in the hands-on production of Humacyte’s regenerative vessels.

ESSENTIAL FUNCTIONS :

Under close supervision of Bioprocessing leadership, performs basic processes and serves as a hands-on resource in Manufacturing Humacyte’s regenerative vessels by :

• Supports the daily activities of vessel production
• Assists with basic / routine cleaning and preparation of production equipment and cleaning / disinfecting of production rooms
• Assists with assembly, set-up, and disassembly of production equipment
• Ensures the proper execution of routine production process steps according to defined SOPs and BPRs
• Ensures 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 Qualification and Validation activities, as assigned
• Ensures that process issues are identified and communicated to Bioprocessing leadership and team
• Assists team effort in the effective and timely completion of root cause investigations and CAPA implementations
• Assists other Bioprocessing

EXPERIENCE & QUALIFICATIONS :

COMPENSATION & BENEFITS HIGHLIGHTS :

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.