Senior Manager, Microbiological Quality and Sterility Assurance PLCM
1 week ago
We are seeking a highly skilled Senior Manager, Microbiological Quality and Sterility Assurance PLCM to join our team. This role will be responsible for supporting the R&D, Pilot Plant, MQSA-NPI/NPD and QHS teams in the development and transfer of scaled-up microbiologically controlled processes.
Key Responsibilities- Lead the characterization efforts of large-scale manufacturing processes to ensure successful scale-up and transfer from lab-scale/pilot plant to commercial manufacturing facilities.
- Champion proactive quality through process design in alignment with design for microbiological controlled manufacturing principles.
- Approve transfers from pilot stages to scale-up, approval of MQSA technical documents, lead root cause analysis and CAPA investigations associated with manufacturing design.
- Maintain suppliers through MRAs and qualification of direct material suppliers.
- Lead MRAS as part of production life cycle, approval of change controls prior to adoption of new suppliers in commercial manufacturing environment and material source changes.
- Define microbiological critical process parameters and cleaning and sanitization (C&S) development and validation.
- Approve technical reports generated from compliance programs (e.g. regulatory inspections, regulatory commitments, and global non-conformances and CAPAs among others).
- Bachelor's Degree in Microbiology, Biochemistry, Biotechnology or related scientific field.
- Minimum of 8-10 years of experience with evidence of progressive increase in responsibility in product development, quality, manufacturing, technical operations, or technical quality functions for regulated consumer products.
- Demonstrated ability to lead global programs with positive impact on product reliability, compliance, and/or performance through creation of resilient programs for microbiological controlled products and processes.
We offer a competitive salary range of $119,000 - $205,850 and a comprehensive benefits package.
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Skillman, New Jersey, United States Johnson & Johnson Consumer Inc Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Manager to lead our Microbiological Quality and Sterility Assurance (MQSA) team. As a key member of our Quality and Sterility Assurance organization, you will be responsible for ensuring the development and transfer of scaled-up microbiologically controlled processes.Key...
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