Contract - MSAT/CMC Biologics Drug Product Lead
Position Summary:
This role is responsible for managing all aspects of the Phase III drug product development and production of a monoclonal antibody program. This role will have ownership of Manufacturing, and validation activities of a biologic product at the CDMOs; serving as a technical subject matter and site manager. This position collaborates closely with colleagues in Technical Operations, Quality, and Regulatory, supporting the corporate objectives through BLA approval and commercial launch.
Essential Duties and Responsibilities:
- Oversee GMP production, material assessment and GMP release of Parenteral Drug Product material at external Contract Manufacturing organization.
- Design and execute Stage 1-2 validation at Contract Manufacturing Facility, providing input and owning Validation Master Plan and other relevant internal documents.
- Review and approve manufacturing related documents including change notifications, batch records, process development, tech transfer, and validation protocols/reports
- Provide technical support for quality systems governing GMP manufacturing including deviations, investigations, CAPAs, change controls, regulatory submissions, and facility inspections.
- Prepare CMC sections of regulatory submissions.
- Expert knowledge in filling development and validation for parenteral, technology transfer procedures, and cleanroom requirements.
Qualifications:
- Local or remote position with domestic travel as applicable (up to 25%) for right candidate.
- B.S. degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or other related discipline. M.S. degree preferred. Equivalent combination of education and applicable job experience may be considered.
- 8 years of relevant experience including biologics drug product manufacturing, scale-up, and late-stage drug development.
- Demonstrated hands on experience with parenteral DP manufacturing at external CMO including technical transfers and process validation deliverables
- Technical, MSAT, engineering background a plus
- Self-motivated with strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
- Strong communication skills and emotional intelligence to communicate and interact internally and with external contractors to drive program deliverables
- Knowledge of cGMP with a detailed understanding of all stages of Process Validation lifecycle in biologics with Process Design, PPQ, and Continued Process Verification (CPV)