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Process Development Engineer

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:

  • Provide engineering support for scale-up of the manufacturing process for a human acellular vessel product
  • Design and perform experiments with small scale bioproduction systems to demonstrate feasibility and robustness of process scale-up and proposed process changes
  • Evaluate and optimize design of custom bioreactors and fluid management systems
  • Design novel equipment, components, subassemblies, and/or procedures that can be implemented as improvements to the manufacturing process
  • Assist process development team in testing prototype equipment for the production of tissue engineered products in bioreactors
  • Sample culture media from bioreactors and measure metabolites to collect in-process data
  • Analyze data using graphical and statistical methods
  • Identify potential changes to the manufacturing process that minimize risk, increase process efficiency or operability, or otherwise improve the process
  • Identify and implement equipment upgrades associated with process improvement
  • Promote transparency around process engineering activities through routine internal updates
  • Oversee transition of newly developed methods to comply with regulatory and quality control requirements
  • Scale-up and technology transfer for commercial manufacturing
  • Responsible for troubleshooting during development, technology transfer, and product manufacture
  • Manage data during process development studies (batch records, images, reports)
  • Maintain laboratory notebooks, prepare and review written protocols, reports and SOPs, and present results at company meetings
  • Support regulatory filings

Requirements:

  • PhD in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or similar field
  • Prefer 2 years of industry experience in bioprocessing and engineering
  • Strong analytical and problem solving skills
  • Strong knowledge of GMP quality systems
  • Strong background in aseptic processes
  • Detail-oriented, self-motivated and scientifically driven 

  • Excellent communication and interpersonal skills

  • Demonstrated ability to work in a cross functional team

Bonus Points:

  • Background in one or more specialties of mechanical engineering, biomedical engineering, and/or chemical engineering
  • Expertise in the areas of bioprocess development, bioprocess engineering, prototype equipment design, mechanics, experimental design, and data acquisition and analysis

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