2D Bioprocessing Associate II
HUMACYTE GLOBAL INC
Summary
The 2D Bioprocessing Associate II participates in the hands-on production of Humacyte's regenerative vessels.
Job description
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
Requirements
- 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
- Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
- 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 sit; stand for prolonged periods of time; may occasionally be required to pull, lift and/or move up to 20 pounds
- Position may require working holidays, weekends and overtime
Benefits
- Stock Options
- 401(k) Matching
- Medical, Dental & Vision
- Company Paid Disability
- Company Paid Life Insurance
- 23 Days PTO
- 10 Holidays + 2 Floating
- Paid Parental Leave
Company overview
Humacyte Global Inc. (Nasdaq: HUMA) is a pioneering biotechnology company specializing in regenerative medicine and tissue engineering. Founded in 2004 and headquartered in Durham, North Carolina, the company has developed a groundbreaking bioengineering platform that creates universally implantable, acellular tissue engineered vessels (ATEV™). In December 2024, Humacyte achieved a significant milestone when the FDA granted full approval for its first product, Symvess™, an acellular tissue engineered vessel for extremity arterial trauma repair. This represents the first FDA-approved, human-derived biologic vessel for vascular injury treatment. The company's innovative platform transforms human cells into off-the-shelf regenerative tissues designed to be universally implantable and capable of remodeling with the patient's own cells over time. Humacyte's technology is being investigated for multiple clinical applications including arteriovenous access for hemodialysis, peripheral arterial disease, coronary artery bypass grafts, and treatment of type 1 diabetes. With over 215 employees, the company continues to advance its mission of engineering regenerative medicine products to save and improve patient lives through bioengineered human tissues and organs.