Position:

Reports To: DPD Division MSAT Head

Location: Remote US / EU

Preferred Locations:

• France, Bourgoin
• UK: Swindon

These locations are key sites for our operations.

Position Summary

Your outstanding skills will help our sterile sites introduce new products, improve capabilities, and reduce compliance risks.

Key Responsibilities

• Provide SME expertise in APS and Smoke Studies for sterile pharmaceutical processes.
• Establish division strategy and update global standards in collaboration with global Sterility Assurance.
• Ensure APS and Smoke Studies approaches are consistently applied across the DPD sterile sites.
• Provide complete support on APS topics such as design and operational considerations, reducing compliance risk, and following execution protocols.
• Provide expertise in process characterization to increase robustness and sustainability.
• Assist in troubleshooting and root cause investigation by harmonizing technical processes.
• Review and improve sterile site aseptic practices and technologies.
• Collaborate with sterile manufacturing teams to successfully implement new technologies and ensure timely product launches.
• Monitor GMP, EU, and FDA regulatory changes and review industry journals.
• Support aseptic manufacturing projects, including equipment and process integration.
• Provide expert technical support in aseptic manufacturing, validation, new technologies, and sterilization.
• Identify and drive opportunities for improvement in process efficiency and product quality.
• Develop and align training curriculum for site SMEs, ensuring standard methodologies across sites.

Stewardship for Aseptic Network & New Product Launch

• Serve as the Network SME collaborating with local and global MSAT networks and technical development organizations.
• Define and implement new technical standards for existing and new technologies and equipment.
• Benchmark internally within DPD and externally in scientific and academic environments to extend knowledge and stimulate innovation.
• Author and implement GOPs for assigned technologies.

Qualifications and Requirements

• MSc or equivalent experience in Pharmacy, Pharmaceutical Technology, Chemistry, or a related scientific field.
• 10+ years of professional experience in GMP manufacturing relevant to the specialist area of expertise.
• Proven process understanding in Pharma, GMP, and Regulatory aspects.
• Up to 30-40% travel as needed.
• Confident communicator both verbally and in writing.
• Able to influence others, build cross-functional teams, and set clear business objectives.
• Demonstrated leadership and technical experience.