2D Bioprocessing Associate II

Humacyte•Durham, NC

2d•Onsite

About The Position

The 2D Bioprocessing Associate II is part of Site Operations and participates in the hands-on production of Humacyte’s regenerative vessels. The role performs basic-to-moderate-scope manufacturing processes and serves as a hands-on resource for vessel production. Work is performed onsite in Durham, North Carolina, including time in a clean-room environment while following applicable gowning and personal protective equipment guidelines. The associate supports vessel production, equipment and room preparation, process execution, documentation, process control, and quality activities. The role works with other Bioprocessing Team Members and leadership, handles chemically hazardous goods appropriately, and may train team members on minor tasks and equipment. The position may require work on holidays and weekends, as well as overtime.

Requirements

High school diploma or GED.
At least 2 years of previous experience in pharmaceutical, biotechnology, and/or sterile production environments.
Basic knowledge of cGMP requirements.
Experience executing SOPs and documenting work.
Basic computer skills, including knowledge of MS Word, Excel, PowerPoint, and Outlook.
Ability to work in a clean-room environment and meet applicable gowning and personal protective equipment guidelines.
Ability to regularly sit and stand for prolonged periods; may occasionally need to pull, lift, and/or move up to 20 pounds.
May be required to work holidays, weekends, and overtime.

Nice To Haves

Associate or bachelor’s degree.
Basic mechanical aptitude or knowledge of electrical/mechanical equipment.
Previous cell culture experience (highly preferred).

Responsibilities

Perform daily activities required for vessel production.
Partner with other Bioprocessing Team Members during launches.
Recognize and solve typical problems in the work area without supervisory approval.
Support projects of moderate scope, such as operational excellence and safety initiatives.
Support collection and tracking of area metrics and process control data.
Clean and prepare production equipment, and clean and disinfect production rooms.
Support assembly, setup, and disassembly of production equipment.
Execute process steps according to defined SOPs and BPRs.
Document activities properly in accordance with cGMPs.
Handle chemically hazardous goods appropriately.
Interface with process automation and electronic business systems.
Support revisions of SOPs and BPRs.
Support qualification and validation activities as assigned.
In collaboration with Bioprocessing leadership, recognize and troubleshoot moderate-scope process issues and initiate deviations.
Support timely completion of root-cause investigations and implementation of CAPAs.
Train other team members on minor tasks and equipment.
Perform other duties as assigned.