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Associate Director, Quality Control Microbiology

Regulatory | 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:

  • Manage all EM investigations, deviations, out of alert/action limits, out of trends, and Corrective and Preventive Actions

  • Manage, monitor, track and trending of EM trend reports • Generate monthly, quarterly reports

  • Manage, monitor, review and track all reviews of test documentations, batch report summary

  • Schedule, coordinate and oversee all activities related to the EM Program

  • As necessary and as assigned schedule, coordinate and oversee activities related to the EM Program including utilities ensuring compliance with regulatory requirements and Intarcia standard operation procedures

  • Oversee Intarcia's gowning program including periodic gown qualifications

  • Review and approve SOPs, Specifications, PST protocols and reports associated with microbiology and EM as necessary

  • Train the manufacturing personnel in environmental monitoring sampling and other aseptic processing techniques (as required).

  • Prepare and review documents related to microbiology and EM in support of regulatory filings (IND, IMPD, BLA, NDA

  • Represent QC operations during regulatory inspections (PAI, General) including ISO notified body inspection, internal and partner audits

  • Manage other QA/QC responsibilities as assigned by the supervisor

Requirements:

  • Minimum BS degree in Microbiology, biology, biochemistry, or related science
  • Minimum 10 years of experience in the biotechnology field performing and managing Environmental Monitoring and Microbiology

  • Minimum 5 years of direct personnel management experience

  • Prior experience supporting supplier audits and regulatory inspections required

  • Thorough understanding of nature and application of U.S. FDA and European regulations with respect to aseptic processing, biologics manufacturing, and human cell and tissue-based products, including but not limited to:21 CFR Parts 11, 210, 211, 600, 820, and 1271; and relevant European Directives (2004/23/EC, 2006/17/EC, 2006/86/EC and 2012/39/EU)

  • Demonstrated experience leading EM/Microbiology staff at all levels in a GMP environment

  • Thorough understanding of root cause analysis, change control requirements, and other fundamental elements of Quality Systems

Bonus Points:

  • Functional understanding of microbiological testing requirements for biological products and application for in-house and outsourced laboratories
     
  • Manage other QA/QC responsibilities as assigned

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