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Director Manufacturing, Science and Technology
- Posted 19 June 2024
- LocationSt Louis MO63131
- Job type Permanent
- Discipline Manufacturing & Operations
- Reference198566
- Contact NameGreg Hammond
Job description
BioTalent have partnered with a Global CDMO to search for a Director of MSAT to join their site leadership team in Missouri. As the Director of MSAT, you will be responsible for a large team focused on Tech Transfer into manufacturing, Continued Process Verification, and Process Validation.
BioTalent Ltd are acting as an employment agency in relation to this opportunity.
This role will offer you:
- Opportunity to lead a high performing MSAT department within one of the most known CDMOs in the world.
You will be responsible for:
- Plan and execute the MSAT departments strategy for technology transfer from process development through to commercial manufacturing.
- Facility fit assessment, tech transfer activities, coordination of process start-up activities including Engineering Runs, GMP/clinical, PPQ and routine commercial runs, and resulting 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.
You will bring the following:
- BS, MS, or PhD in Biotechnology, Chemical or Pharmaceutical Engineering, or related field alongside significant leadership experience across Bioprocessing leadership.
- 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 are acting as an employment agency in relation to this opportunity.