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Process Development Associate

Development | 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:

The Process Development Associate will be a hands-on position, performing experimental protocols within the Process Development lab.  This R&D position is critical to the support of the company’s development effort. Key responsibilities include:

  • Perform and document process development experiments

  • Aseptic sample collection and analysis using cell counters, dissolved gas analyzers, and metabolite analyzers.

  • Data acquisition for continuous process monitoring

  • Reporting of unexpected findings and observations during bioprocessing

  • Troubleshooting of processes and equipment

  • Participate in weekly team meetings

  • Setup, daily monitoring, and breakdown, of bioreactor experiments

  • Aseptic compounding and aliquoting of cellular growth medium and buffers

  • Construction and packaging of bioprocessing tubing manifolds

Requirements:

  • Education – Bachelor’s degree in biology, chemistry, or other related field.
  • Experience – 2-5 years of experience with bioprocessing, cell therapy, tissue engineering, or regenerative medicine
  • Strong analytical and problem solving skills
  • Strong background/technique in aseptic processing
  • Knowledge of GMP quality systems
  • Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment
  • Familiarity and understanding of basic and/or advanced cGMP compliance in the biotech/bioprocessing manufacturing environment
    • Knowledge of Code of Federal Regulations 21 CFR 1271 a plus
  • Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook

Bonus Points:

  • Experience in Process Development a plus
  • Bioreactor experience a plus
  • Detail-oriented, self-motivated and scientifically driven 

  • Excellent communication and interpersonal skills

  • Demonstrated ability to work in a cross functional team
  • At least 3 years of relevant pharma or biotech industry experience

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