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:

• High School Diploma or GED required
• Associate or Bachelor’s degree, preferred
• 0-1 years of previous experience in pharmaceutical, biotechnology, and/or sterile production environments preferred
• 0-1 years of cGMP knowledge and requirements, executing SOPs, and documenting work, preferred
• Basic mechanical aptitude or knowledge of electrical/mechanical equipment, preferred
• Previous cell culture experience, highly preferred
• Prior training in or knowledge of gowning in a clean room setting including proper use of PPE preferred
• Excellent communication and interpersonal skills.
• Possess a positive roll-up-the-sleeves attitude and optimistic outlook.
• Strong ability to work in a fast-paced team environment with fluctuating priorities and demonstrated ability to collaborate within cross functional teams.
• Excellent organizational and time management skills with ability to set own priorities in a timely manner.
• High degree of flexibility and adaptability.
• Self-motivated and organized critical thinker with solid interpersonal and business communication skills.
• Represents the organization in a positive and highly professional manner.

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 3^rd 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.