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Raw Materials Manager

Quality Assurance | 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.


  • Responsible for ensuring that the Raw Material program is properly developed and managed, inclusive of contract testing lab qualification and oversight

  • Ensure interdepartmental training is supported including technical writing necessary to support specification development, SOP implementation and trending. Ensure raw material documents remain current and in Compliance with GxP requirements
  • Manage raw material testing following Humacyte internal procedures, United States Pharmacopoeia (USP), European Pharmacopoeia (EP), American Chemical Society (ACS) and/ or Internal Validated Methods
  • Ensure proper support and utilization of enterprise systems as applicable to support activities within the RM function (e.g. Deviation Management, Change Control)
  • Collaborate with Manufacturing, Supply Chain and Logistics to ensure an uninterrupted supply of materials for use in Manufacturing
  • Ensure programs for trending are in place including assessment for CAPAs based on trend conclusions
  • Drive the implementation and sustained Compliance
  • Support and help ensure the overall state of Compliance for the Raw Material Program including support for Data Integrity initiatives
  • Collaborate and provide support, as needed, to ensure the supplier qualification program is properly implemented and maintained
  • Participate in audits (internal / external) where necessary (prep, support, interactions) internal/external audit program
  • Ensure health & safety procedures are followed


  • Bachelors or Master’s Degree in: Pharmaceutical Technology, Biomedical Engineering, Biology or Chemistry
  • Candidate will possess a demonstrated manufacturing and quality foundation in a pharmaceutical environment
  • 6-10 years of pharmaceutical work experience, preferably in medical devices or biologics with 3-5 years of supervisory or management experience
  • Demonstrated background in support of pharmaceutical manufacturing and quality systems.
  • Excellent written and oral communication skills
  • Experience leading investigations, writing change controls and managing non- conformances
  • Background in one or more specialties of Pharmaceutical Technologies, Biology, Biomedical Engineering or Chemistry
  • Understanding of Quality Systems, Quality Operations and Manufacturing processes

Bonus Points:

  • Process Knowledge:
    • Strong problem solving and analytical skills
    • Experience managing and developing a Quality Operations team.
    • Detailed oriented, self-motivated and scientifically driven
    • Demonstrated ability to work in a cross functional team
    • Excellent communication and interpersonal skills
    • Firm understanding of Quality Operations and Quality System in a Pharmaceutical Manufacturing environment
    • Proactively investigate and resolve discrepancies
    • Ability to resolve issues quality system issues, related to deviations, non- conformances change controls etc.
    • Proficient with Microsoft Word, Excel, PowerPoint and Visio
  • Communication:

    • Documentation of non-conforming events (NCEs), write-ups, root cause analysis and CAPAs
    • Cross-functional communication and training staff on all operations are critical aspects of this position
    • Good written communication skills. Clearly communicates issues with co-workers and supervision and communicates in a timely manner.
    • Strong oral and written and skills. Capable of writing management level reports and summaries.
    • Effectively communicates issues to management related to quality operations.


  • 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