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

Thermo Fisher Scientific Inc.; Oregon (IL); Remote; USD 100,000 - 140,000; Full time

Job summary

A leading company seeks an expert in Isolator Technology to join their remote technical team. This role involves key responsibilities in the pharmaceutical sector, focusing on GMP, new technologies, and improving aseptic manufacturing processes, requiring extensive experience and proven leadership skills.

Qualifications

• Over 10 years of experience in GMP manufacturing.
• Proven understanding of regulatory aspects in Pharma.

Responsibilities

• Provide SME expertise in Isolator Technology for pharmaceutical processes.
• Collaborate with teams to implement new technologies.
• Monitor GMP and regulatory changes.

Skills

Expertise in Isolator Technology

Facility with GMP regulations

Leadership

Technical communication

Education

MSc or equivalent in Pharmacy, Pharmaceutical Technology, Chemistry

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.