Senior Manager, Microbiological Quality and Sterility Assurance PLCM

1 week ago


Skillman, New Jersey, United States Johnson & Johnson Consumer Inc Full time
Job Summary

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).
Requirements
  • 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.
What We Offer

We offer a competitive salary range of $119,000 - $205,850 and a comprehensive benefits package.



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