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

Thermo Fisher Scientific Inc.; Milano; Ibrido; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

A leading company in the pharmaceutical sector is seeking an expert in Isolator Technology to join their remote team. This role involves providing technical expertise in aseptic processes, developing global standards, and collaborating with manufacturing sites for product launches. Candidates should have a strong background in GMP manufacturing and relevant scientific qualifications.

Competenze

• 10+ years of experience in GMP manufacturing.
• Proven process understanding in Pharma and Regulatory aspects.
• Ability to influence and build cross-functional teams.

Mansioni

• Provide SME expertise in Isolator Technology for pharmaceutical processes.
• Support troubleshooting and root cause investigations.
• Collaborate with manufacturing teams to implement new technologies.

Conoscenze

Leadership

Technical Expertise

Communication

Process Understanding

Formazione

MSc in Pharmacy, Pharmaceutical Technology, Chemistry

Descrizione del lavoro

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

• 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 topics related to Isolator Technology, including Decontamination Cycles, Environmental Monitoring, and Cycle Development.
• Support sites in troubleshooting and root cause investigations by providing second-level specialist expertise and harmonizing related technical processes across units.
• Review sterile site aseptic practices and develop plans for improvements.
• Collaborate with sterile manufacturing site teams to implement new technologies and ensure timely product launches.
• Monitor GMP, EU, and FDA regulatory changes and requirements continuously.
• 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 extend knowledge and grow expertise among team members.
• 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.
• 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 expertise.