Head of MSAT - Drug Product

Head of MSAT (Drug Product) - Germany

QP Group has partnered with a well-backed biopharmaceutical company establishing a new, state-of-the-art sterile drug product manufacturing site close to Berlin. They're actively looking to hire a Head of MSAT to lead their drug product manufacturing, leading the Drug Product MSAT function from the ground up as part of the facility start-up.

• Serve as the primary technical interface with CDMO clients on all DP process matters.
• Own the technical transfer of client drug product processes into the site, from formulation through fill/finish.
• Provide MSAT technical support to drug product manufacturing operations including compounding, filtration, filling, and lyophilisation
• Lead process characterisation, scale-up, and optimisation for drug product unit operations
• Author and review the drug product sections of process validation strategies, PPQ protocols, and reports

• Degree in Chemical Engineering, Pharmaceutical Sciences, Biotechnology, or a related discipline; advanced degree preferred.
• 10+ years' experience in drug product process development, MSAT, or manufacturing science within biologics
• Deep knowledge of sterile fill/finish operations for biologics including liquid and lyophilised presentations.
• Proven track record leading technical transfers into a GMP manufacturing environment