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Senior Process Engineer

Operations, Product 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 Senior Process Engineer will be a key contributor to troubleshooting of existing manufacturing processes, working with personnel in Process Development, Manufacturing, Quality Assurance and Quality Control.  The Senior Process Engineer will also participate in process improvement and design of controlled studies to document process stability and control.  The engineer will also be involved with technology transfer of the commercial manufacturing system components into the commercial manufacturing facility.  The successful candidate will:

  • Most importantly, this engineer will lead efforts in troubleshooting manufacturing processes that become out-of-trend or out-of-specification, providing the intellectual, scientific and engineering leadership to pinpoint process drift and/or failures, and to identify and implement scientific, engineering and technical solutions

  • Help implement robust biological processes for the production of tissue-engineered and tissue-based products in clinical and commercial production settings

  • Work closely with the internal Humacyte Process Development and Engineering team

  • Work with others in Manufacturing and Quality Assurance to develop and execute validation strategies to assure that production processes meet regulatory quality requirement

  • With Humacyte Quality Control and Quality Assurance, help implement monitoring assays and sampling protocols

  • Identify areas where new SOPs are needed to enhance process control and robustness

  • Assist in installation qualification, operational qualification and performance qualification validation protocols

  • Interface at different levels of bioprocessing and is hands-on to help in the transitioning of new technology into the manufacturing facility.  Cross-functional communication and training staff on all operations are critical aspects of this position.  Flexibility is key to being a successful applicant for this position.

Requirements:

  • PhD or MS and substantial industry experience (minimum 10 years) – or –
  • PhD in relevant Biological field and experience in scaled cell culture processes, mass transfer and automation considerations, and 2-5 years industry experience
  • Candidate will possess a demonstrated technical foundation of cell- and tissue-based products and bioprocess manufacturing
  • Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, process development, and/or cell biology
  • Highly motivated and organized
  • Works and leads well in a team environment

Qualifications:

Process Knowledge:

  • Possesses firm knowledge of the cell biological aspects of the process, as well as the engineering and mass-transfer aspects of the process
  • Possesses firm understanding of equipment and procedures, and identifies potential problems before they occur
  • Able to train others on theory and concepts behind the process including an understanding of the impact of any process changes or improvements, as well as the impact of any process deviations or drift
  • Able to assist in development and implementation of process specs, process parameters, operating ranges, alert/action limits
  • Skilled in advanced biotechnology processing – integration of major unit operations and microbial control concepts
  • Identify areas where process development is needed, and communicate those needs to the Process Development team

Problem Solving:

  • Critical thinker and problem-solver absolute requirements
  • Able to develop solutions and implement process improvements to manufacturing problems, and can confidently deal with corrective actions
  • Acts as a resource for both process development and manufacturing, and participates in strategic process development
  • Can design, execute and interpret data from targeted experiments with little to no supervision

Communication:

  • Effectively communicates within and across teams
  • Strong oral and written communication skills.  Capable of writing management level reports and summaries.  Clearly communicates scientific and process issues with co-workers and supervisors, and communicates in a timely manner

Bonus Points:

  • Experience with engineering operation of scaled industrial processes for growth of adherent mammalian cells

    • Familiar with technical and engineering operations of scaled cell culture systems

    • Familiar with feedback control and monitoring of relevant process gasses, nutrients, biological waste products in mammalian cell systems

  • Understanding and technical competence with

    • Mass transfer and gas transfer characteristics

    • Fluid handling/mechanics

    • Aseptic manufacturing

  • Demonstrated skills in a broad spectrum of bioprocess applications, leadership, and mentoring of staff

  • Able to troubleshoot bioprocess activities and perform typical bioprocess optimization studies

  • Familiar with application of statistics to in process measures of biological systems in a controlled production environment

  • Cell biology competence/background and tissue culture development 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