Raw Materials Manager
Quality Assurance | Research Triangle Park, NC | Full Time
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
- 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
- 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