Bioprocessing Associate III
Operations: Bioprocessing/CTS | Research Triangle Park, NC | Full Time
Humacyte's mission is to become the leading company in novel, off-the-shelf extracellular matrix tissue products, and especially those that could provide lifesaving improvements in treatments for vascular conditions.
Humacyte, Inc., a biotechnology pioneer, discovers, develops and delivers innovative, award winning human biotherapies. We are currently developing multiple vascular tissue engineered therapies and expanding our business model. With a broad pipeline of potential new therapy applications, we continue to build our organization and scientific teams.
- Becomes expert on processes and equipment and serves as a hands-on resource in Manufacturing.
- Conducts all assigned activities in a safe and cGMP manner. Tasks will include, but are not limited to:
- Cleaning and preparing production equipment
- Cleaning and disinfecting production rooms
- Assembly, set-up, and disassembly of production equipment
- Executing process steps according to defined SOPs and BPRs
- Documenting activities in accordance with cGMPs
- Handling chemically hazardous goods
- Advanced understanding of process automation and electronic business systems
- Leading projects of medium scope (e.g. operational excellence, safety)
- Authoring SOPs and BPRs
- Supporting qualification and validation activities
- Qualified trainer on major tasks and equipment
- Support coordination of equipment and personnel resources on a daily basis
- Recognizing issues and effectively solving atypical process issues
- Leads the collection and tracking of area metrics and process control data
- Leads team effort in the effective and timely completion of root cause investigations and CAPA implementation
- Bachelor’s degree in science preferred
- Demonstrated leader with high school diploma / GED or associate’s degree with 4+ years industry related experience (pharmaceutical, biotechnology, and/or sterile production environments) preferred OR bachelor’s degree with 3+ years’ industry experience preferred OR equivalent.
- Demonstrated knowledge of cGMP requirements required.
- Experience executing SOPs and documenting work required.
- Basic mechanical aptitude or knowledge of electronic / mechanical equipment preferred.
- Demonstrated competence in clean room environment practices with ability to train others
Has developed proficiency in a range of analytical/scientific methods or operational processes through job-related training.
Able to troubleshoot mechanical and/or process issues.
Completes a variety of atypical assignments, as needed.
Has a good understanding of how related teams coordinate their efforts and resources to achieve objectives.
Works as a team player, participating in activities that involve cooperating with others.
Applies functional and technical knowledge across a range of processes or operational procedures to deliver high quality work.
- Stock Options
- 401k Plan with Matching
- Medical, Vision and Dental Plans
- Long Term/Short Term Disability
- Life Insurance
- 3 Weeks’ Vacation
- 5 Personal Floating Days
- 8 Sick Days
- 6 Company Holidays
- Career Development and Training