NKMax America is seeking an experienced leader responsible for managing NK cell therapy manufacturing in a pharmaceutical environment. Also responsible for phase appropriate validation and maintenance of manufacturing equipment in GMP compliance, work with other NKMax sites for method transfers and be accountable for managing manufacturing projects and timelines. This is a hands-on role responsible for developing, implementing and maintaining GMP systems for a clinical stage cell therapy company.
- Provides functional leadership including hiring and managing a professional, high performing cell therapy manufacturing staff designed to meet the technical and compliance requirements of a growing company.
- Develop, implement and maintain manufacturing systems.
- Generate SOPs, batch records, and other manufacturing related documents
- Manage, investigate, review and/or approve deviations, non-conformances, change controls and CAPAs as required.
- Partner with Quality to support all quality activities related to the manufacturing and release of clinical product including resolution of investigations and quality issues.
- Responsible for ensuring that all drug substance and drug product are manufactured in accordance with NKMax’s specifications, in compliance with cGMP and consistent with applicable regulatory filings.
- Responsible for timely review and release/disposition of cell therapy product and clinical trial supplies.
- Review and approve IQ/OQ/PQ and validation protocols, tech transfers and reports, as applicable.
- Monitor the GMP systems currently in place to ensure compliance with documented policies.
- Develop and implement annual manufacturing plans, departmental goals, action plans, and budgets.
- Independently report metrics to executive management.
- Drive continuous improvement utilizing quality tools such as lean, six sigma, and risk management.
- Internally collaborates with research, clinical, process development, and quality groups.
- Externally collaborates with contract service providers and corporate partners in support of supply chain objectives.
- Other duties as assigned.
Job Qualifications and Skills
- At least 15 years in a technical role manufacturing, QA or product development and at least 10 years in a related management role, leading technical staff.
- Bachelor’s degree in biological sciences required. Advanced science or engineering degree highly preferred.
- Education, training, or experience in cell therapy a plus.
- Lean or Six Sigma certification preferred but not required.
- Working knowledge of GMP quality systems, regulatory requirements, relevant pharmacopeia and guidance documents.
- Demonstrated ability to successfully interact with regulatory health authorities at inspections (prior experiencing leading inspections is preferred).
- Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity.
- Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to work independently and as part of a team.
- Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
- Candidates must be authorized to work in the U.S.