Director of MSAT Leadership
2 weeks ago
BioTalent has partnered with a leading Global CDMO to seek a seasoned Bioprocessing Director to lead their MSAT department in Missouri. As the Director of MSAT, you will oversee a team focused on Tech Transfer into manufacturing, Continued Process Verification, and Process Validation.
This role offers:
- Opportunity to lead a high-performing MSAT department within a renowned CDMO.
Responsibilities:
- Develop and execute the MSAT department's strategy for technology transfer from process development to commercial manufacturing.
- Facilitate facility fit assessments, tech transfer activities, and process start-up activities, including Engineering Runs, GMP/clinical, PPQ, and routine commercial runs, with risk mitigation activities.
- Support manufacturing activities with active process monitoring and data trending, process deviation resolution, process improvements, and scientific expertise in the Drug Substance field.
- Provide strong technical leadership to process engineers, scientists, and associates for clinical and commercial production.
- Represent the site as a domain expert during external and internal regulatory compliance inspections.
Requirements:
- BS, MS, or PhD in Biotechnology, Chemical, or Pharmaceutical Engineering, or a related field, with significant leadership experience in Bioprocessing.
- Broad experience in all process areas (Upstream cell culture, downstream processing, buffer and media preparation) and ancillary processes (CIP, SIP).
- Experience leading GMP manufacturing, process validation, and tech transfer teams and projects.
BioTalent Ltd acts as an employment agency for this opportunity.
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Director of MSAT Leadership
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