3D Bioprocessing Associate II

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 3D Bioprocessing Associate II participates in the hands-on production of Humacyte’s regenerative vessels.

ESSENTIAL FUNCTIONS:

• Performs daily activities required of vessel production
• Partners with other Bioprocessing Team Members during launches
• Recognizes and solves typical problems that occur in own work area without supervisory approval
• Supports projects of moderate scope (e.g. operational excellence, safety)
• Supports the collection and tracking of area metrics and process control data
• Performs cleaning and preparation of production equipment, and cleaning/disinfecting of production rooms
• Supports the assembly, set-up, and disassembly of production equipment
• Ensures process steps are executed 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 the revisions of SOPs and BPRs
• Supports 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
• Trains other team members on minor tasks and equipment
• Other duties, as assigned

EXPERIENCE & QUALIFICATIONS:

• High School Diploma or GED, required. Associate or Bachelor’s degree, preferred.
• 2 years of previous experience in pharmaceutical, biotechnology, and/or sterile production environments, required
• Basic knowledge of cGMP requirements, required
• Experience executing SOPs and documenting work, required
• Basic 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
• Will be required to regularly to sit; stand for prolonged periods of time. Also may occasionally be required to pull, lift and/or move up to 20 pounds
• Position may require working holidays, weekends and over-time

COMPENSATION & BENEFITS HIGHLIGHTS:

• 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
• 23 Days Paid Time Off (PTO)
• 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.