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Process Development Engineer, Biomaterials

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 Engineer will be a hands-on position, performing experimental protocols within the Process Development lab, also making supplies for Phase III clinical trial. This R&D position is critical to the support of the company’s development effort and Phase III clinical trial.

Position reports to Executive Director, Process Development

Primary Responsibilities:

  • Support projects by conceptualizing and executing process development studies. Projects will include, but not limited to:
    • Extending shelf life of single use bioreactor bags
    • Improving cell inoculation efficiency by changing the properties of biodegradable scaffold
  • Support various aspects of the projects including design of experiments, set up, execution and process improvements
  • Data acquisition for continuous process monitoring
  • Reporting of unexpected findings and observation
  • Troubleshooting of processes and equipment
  • Regular maintenance of prototype equipment to support ongoing experiments
  • Draft work instructions for processes under development as needed
  • Serve as subject matter expert when comes to outsourcing process to CMOs
  • Participate in weekly team meetings
  • Cross training on any process within the team as needed
  • Conducts all assigned activities in a safe and cGMP manner. Tasks will include, but are not limited to:
    • Execute process steps according to defined SOPs and BPRs
    • Aseptic compounding and aliquoting of IHPR for Phase III clinical trial
    • Construction of single use bioreactor bag components for Phase III clinical trial
    • Work with Quality Assurance team to update SOPs or BRPs as needed
    • Routine communication with inventory management team. Manage inventory for IHPR and Biotextiles production through WOW or IRF
    • Work with equipment management team to ensure all equipment is calibrated
    • Inspection, analysis and summarization of data from vessel imaging for quality control
  • Construction of small-scale bioreactor bags to support cell donor screening
  • Inspection of biodegradable scaffolds to support stability runs
  • 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:

  • Must be able to strictly follow SOP procedures and report any problem as it comes up.
  • 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
  • Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment
  • Demonstrated ability to work effectively within a team environment to set goals, execute project plans, monitor progress, and report observations scientifically

QUALIFICATIONS:

  • B.S., M.S. or PhD degree in bioengineering, materials science, or other related field
  • 2+ years of working experience in bio/pharma industry. Higher degree may require less working experience
  • Experience with IHPR compounding and handling mesh scaffold is a plus
  • Strong background/technique in aseptic processing
  • Experience in Process Development is a plus
  • Bioreactor experience is a plus
  • Experience modifying or designing own parts/machines/equipment is 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

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