Director Manufacturing, Science and Technology

Posted 19 June 2024
Location
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.
 

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.