MSAT Project Manager

• Oversee activities across multiple client products.
• For drug product clinical trial supply and technology transfers:
  Perform facility fit assessments, support the quotation process in collaboration with business development, establish project timelines with internal stakeholders
• Act as the primary customer contact for deliverables, timelines, risks, and technical matters.
• Partner with subject matter experts across functions (MSAT, Analytical Development, Manufacturing, QC, etc.) to execute project plans.
• Contribute to product-specific equipment qualification, process validation strategies, and testing/control strategies aligned with regulatory and customer expectations.
• Author or contribute to source documentation supporting regulatory submissions (IND, IMPD, MAA, Variations).
• Review regulatory CMC documentation as required.

Education & Experience Requirements:

• Master’s or Ph.D. in Biology, Bioengineering, Biotechnology, or a related discipline.
• 5+ years of experience in pharmaceutical project management and/or progressively responsible roles within process development.
• Hands-on experience in aseptic processing and/or process transfers is strongly preferred.
• Fluency in French and English.

If interested in this posting please feel free to contact Seán McCarthy on +353 (0) or sean.mccarthy for further information.