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Process Development Associate I

All Openings | Research Triangle Park, NC | Full Time

Job Description

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 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.

 Position reports to Process Development Operations Manager

Primary Responsibilities:

  • 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
  • Response and troubleshooting process alarms
  • 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
  • Detail-oriented, self-motivated and scientifically driven
  • Motivated and organized critical thinker with solid interpersonal and communication skills
  • Strong analytical and problem-solving skills
  • Demonstrated ability to work in a cross functional team
  • Routinely communicate findings and information to other team members; transparency and knowledge sharing is expected and practiced
  • Must be able to work as needed to meet tight deadlines and at peak periods

Special Competencies:

  • Knowledge and experience with standard and advanced bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment
  • 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

QUALIFICATIONS:

  • Bachelor’s degree in biology, chemistry, or other related field
  • Previous experience with cell culture, required
  • At least 1 year of experience with bioprocessing, cell therapy, tissue engineering, or regenerative medicine, preferred
  • At least 1 year of relevant pharma or biotech industry experience or training, preferred
  • Experience in Process Development a plus
  • Strong background/technique in aseptic processing
  • Knowledge of GMP quality systems
  • Bioreactor experience a plus
  • Knowledge and experience with standard and advanced bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment

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

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