MS&T Director - Sterile Technical SME (Isolators - VHP)

Thermo Fisher Scientific; United Kingdom; Remote; GBP 60,000 - 80,000; Full time

Job summary

Join a leading company in pharmaceutical technology as a Specialist in Isolator Technology. This remote position requires extensive experience in aseptic processes, regulatory knowledge, and the ability to collaborate and lead cross-functional teams to enhance product launches and technical standards.

Qualifications

• 10+ years of professional experience in GMP manufacturing.
• Proven understanding of Pharma, GMP, and Regulatory aspects.
• Up to 30-40% travel required.

Responsibilities

• Provide SME expertise in Isolator Technology for pharmaceutical processes.
• Collaborate with sterile manufacturing site teams for technology implementation.
• Continuously monitor GMP, EU, and FDA regulatory changes.

Skills

Communication

Leadership

Technical Expertise

Problem Solving

Education

MSc in Pharmacy, Pharmaceutical Technology, Chemistry, or related field

Job description

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

Position Summary

Join our distributed technical team specializing in Isolator Technology on a full-time remote basis. Provide expertise in Isolator Technology, aseptic pharmaceutical processes, and process technologies.

Location: Remote (EU/US)

Preferred Locations:

• Italy: Monza & Ferentino
• UK: Swindon
• North Carolina (US): Greenville
• France, Bourgoin

These locations are key sites for our operations.

Key Responsibilities

Manufacturing Support

• Provide SME expertise in Isolator Technology for pharmaceutical processes – help establish division strategy, develop global standards, and drive harmonization within the DPD sterile sites.
• Offer significant expertise on common topics related to Isolator Technology, including Decontamination Cycles, Environmental Monitoring, and Cycle Development.
• Support sites in troubleshooting/root cause investigations by providing second-level specialist expertise and harmonizing related technical processes across units.
• Review sterile site aseptic practices and set plans for improvements.
• Collaborate with sterile manufacturing site Teams to successfully implement new technologies and ensure timely product launches.
• Continuously monitor GMP, EU, and FDA regulatory changes and requirements.
• Provide expert technical support in aseptic manufacturing, validation, new technologies, and sterilization; facilitate IQ, OQ, and PQ equipment and process qualifications upon request.

Stewardship for Aseptic Network & New Product Launch

• Act as the Network SME for collaborating with Local and global MSAT networks to define and implement new technical standards.
• Ensure internal and external benchmarking to stimulate and extend knowledge, growing know-how among associates.
• 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 (Pharma, GMP, Regulatory aspects).
• Up to 30-40% travel, as needed.
• Confident communicator both verbally and in writing.
• Ability to influence others and build cross-functional teams while setting clear business objectives.
• Demonstrated leadership and technical experience.