Drug Product CMC/MSAT Consultant

Walker Cole International is currently partnered with a global biopharmaceutical company who are searching for an experienced Drug Product CMC / MSAT Consultant with expertise in sterile biologics, aseptic fill-finish and commercial manufacturing, supporting late-stage development through to GMP commercialisation.

The ideal Drug Product CMC/MSAT Consultant would have:

• Led late-stage Drug Product CMC/MSAT activities for sterile biologics, supporting process development from clinical through to commercial manufacture in GMP regulated aseptic manufacturing environments.
• Managed technology transfer, process validation, and commercial manufacturing readiness for biologic drug products, ensuring robust process performance, GMP compliance, and successful site implementation.
• Provided technical expertise across aseptic fill-finish operations for sterile biologics, with experience supporting complex injectable products and lifecycle management within commercial manufacturing facilities.
• Collaborated with cross-functional Process Development, Manufacturing, Quality, and Regulatory teams to optimise sterile biologics manufacturing processes, drive continuous improvement, and resolve technical challenges during scale-up and commercialisation.
• Demonstrated strong experience in biologics, vaccines, and other sterile injectable products, with a focus on drug product manufacturing, MSAT support, and CMC strategy.

Details:

• Part-time or full-time
• Hybrid
• 3-6 months
• Daily rate: £600-800 - Outside IR35

Drug Product | CMC | Manufacturing Science & Technology | MSAT | Sterile | Biologics | Aseptic Manufacturing | Commercial Manufacturing  | Fill-Finish |Process Development | GMP | Good Manufacturing Practice