2D Bioprocessing Associate I

Humacyte•Durham, NC

2d•Onsite

About The Position

The Bioprocessing Associate I participates in hands-on production of Humacyte’s regenerative vessels. Under close supervision of Bioprocessing leadership, this role performs basic manufacturing processes, supports daily vessel production, prepares and cleans production equipment and rooms, and carries out routine production steps according to established procedures. The associate also documents work in accordance with cGMP requirements, handles chemically hazardous goods appropriately, works with process automation and electronic business systems, and supports qualification, validation, investigations, and CAPA activities as assigned. The position is onsite in Durham, North Carolina.

Requirements

High school diploma or GED required.
Excellent communication and interpersonal skills.
Positive, roll-up-the-sleeves attitude and optimistic outlook.
Ability to work in a fast-paced team environment with fluctuating priorities and collaborate across functional teams.
Excellent organizational and time-management skills, including the ability to set priorities in a timely manner.
Flexibility and adaptability.
Self-motivated, organized critical thinker with solid interpersonal and business communication skills.
Represent the organization in a positive and highly professional manner.

Nice To Haves

Associate or bachelor’s degree.
0–1 years of experience in pharmaceutical, biotechnology, and/or sterile production environments.
0–1 years of cGMP knowledge and experience executing SOPs and documenting work.
Basic mechanical aptitude or knowledge of electrical/mechanical equipment.
Previous cell culture experience (highly preferred).
Training in or knowledge of cleanroom gowning and proper use of PPE.

Responsibilities

Support the daily activities of vessel production.
Assist with routine cleaning and preparation of production equipment and cleaning and disinfecting production rooms.
Assist with assembly, set-up, and disassembly of production equipment.
Execute routine production process steps according to defined SOPs and BPRs.
Document activities in accordance with cGMPs.
Handle chemically hazardous goods appropriately.
Interface with process automation and electronic business systems.
Support qualification and validation activities as assigned.
Identify process issues and communicate them to Bioprocessing leadership and the team.
Assist with root cause investigations and CAPA implementations, supporting their effective and timely completion.
Assist other Bioprocessing team members.