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Bioprocessing Associate III

Manufacturing | Research Triangle Park, NC | Full Time

Job Description

About Us:

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.

Responsibilities:

  • 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

Requirements:

  • 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

Bonus Points:

  • 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.

Perks:

  • 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