What are the responsibilities and job description for the 2D Bioprocessing Associate II position at HUMACYTE GLOBAL INC?
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 2D Bioprocessing Associate II participates in the hands-on production of Humacyte’s regenerative vessels.
ESSENTIAL FUNCTIONS :
Performs basic / moderate scope processes and serves as a hands-on resource in manufacturing Humacyte’s regenerative vessels by :
- Performing daily activities required of vessel production
- Partnering with other Bioprocessing Team Members during launches
- Recognizing and solving typical problems that occur in own work area without supervisory approval
- Supporting projects of moderate scope (e.g. operational excellence, safety)
- Supporting the collection and tracking of area metrics and process control data
- Performing cleaning and preparation of production equipment, and cleaning / disinfecting of production rooms
- Supporting the assembly, set-up, and disassembly of production equipment
- Ensuring process steps are executed according to defined SOPs and BPRs
- Ensuring proper documentation of activities in accordance with cGMPs
- Adhering to the proper handling of chemically hazardous goods
- Interfacing with process automation and electronic business systems
- Supporting the revisions of SOPs and BPRs
- Supporting qualifications and validation activities, as assigned
- In collaboration with Bioprocessing leadership, recognizing, troubleshooting, and initiating deviations for process issues of moderate scope
- Supporting team effort in the effective and timely completion of root cause investigations and CAPA implementation
- Training other team members on minor tasks and equipment
- Other duties, as assigned
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.
