Job Description

Responsibilities

  • Lead process development, scale-up, and validation activities from development through commercial GMP manufacturing
  • Establish and implement MSAT processes, tools, templates, and SOPs
  • Support technology transfer activities to ensure smooth handoff into manufacturing
  • Author and review technical documentation including protocols, reports, batch records, deviations, and change controls
  • Develop and execute process and cleaning validation strategies
  • Conduct process risk assessments, gap analyses, and fit-to-plant evaluations
  • Partner with Engineering and Operations on equipment selection, process design, and facility readiness
  • Support media fill planning, execution, and reporting
  • Provide MSAT support during regulatory inspections and audits
  • Act as a technical bridge between development, quality, engineering, and manufacturing teams
  • Promote a strong GMP culture an...

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