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Process Development Lead (2D)

All Openings | Research Triangle Park, NC | Full Time

Job Description

**Please note, Humacyte does not provide sponsorship at this time.**

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.  We are looking for additional biomedical research and development colleagues to continue to build our expanding team.

Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.

Position Background:

The Process Development 2D lead will be a hands-on position, organizing batch activities and performing experimental protocols within the Process Development lab. This R&D position is critical to the support of the company’s development effort.

Position reports to Associate Director, Process Development

Primary Responsibilities:

  • 2D Process Development monthly, weekly, and daily activities scheduling
  • Coordination with Inventory Management to ensure timely delivery and appropriate storage of batch components
  • Training new personnel on 2D process activities
  • Creation and revision of 2D processing records
  • 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
  • Other duties, as assigned

General Competencies:

  • Possess a positive attitude and optimistic outlook
  • Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
  • Excellent organizational and time management skills with ability to set own priorities in a timely manner
  • High degree of flexibility and adaptability
  • Strong communication (verbal and written) and organizational skills
  • Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook

Special Competencies:

  • Familiarity and understanding of foundational and advanced cGMP compliance in the biotech/bioprocessing manufacturing environment
  • Knowledge of Code of Federal Regulations 21 CFR 1271 a plus
  • Strong analytical and problem solving skills
  • Detail-oriented, self-motivated and scientifically driven 

  • Excellent communication and interpersonal skills

  • Demonstrated ability to work in a cross functional team

QUALIFICATIONS:

  • Bachelor’s degree in biology, chemistry, or other related field
  • >5 years of experience with bioprocessing, cell therapy, tissue engineering, or regenerative medicine
  • Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment
  • Strong background/technique in aseptic processing
  • Knowledge of GMP quality systems
  • Experience in Process Development and Biomanufacturing
  • Bioreactor experience a plus

Perks:

  • Stock Options
  • 401k Plan with Matching
  • Medical, Vision and Dental Plans
  • Long Term/Short Term Disability
  • Life Insurance
  • 23 Days Paid Time Off (PTO)
  • 11 Paid Holidays
  • Paid Parental Leave Policies