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

Thermo Fisher Scientific; Monza; Remoto; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A global leader in scientific solutions is hiring for a remote Director specializing in Isolator Technology. The role requires extensive knowledge in aseptic pharmaceutical processes and a minimum of 10 years in GMP manufacturing. Candidates should have strong leadership skills, technical expertise, and the ability to collaborate across functions. This position involves supporting processes and ensuring compliance with regulatory standards, along with monthly travel requirements.

Competenze

• 10 years of professional experience in GMP manufacturing relevant to the specialist area of expertise.
• Proven process understanding of Pharma GMP Regulatory aspects.
• Confident communicator both verbally and in writing.
• Demonstrated leadership and technical experience.

Mansioni

• Provide SME expertise in Isolator Technology for pharmaceutical processes.
• Help establish division strategy, develop global standards, and drive harmonization within the DPD sterile sites.
• Support troubleshooting and root cause investigations.
• Collaborate with teams to implement new technologies and ensure product launches.

Conoscenze

Fundraising

Management Experience

Coaching

Analysis Skills

Strategic Planning

Team Management

Budgeting

Leadership Experience

Mentoring

Public Speaking

Negotiation

Supervising Experience

Formazione

MSc or equivalent experience in Pharmacy or related field

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

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 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 successfully implement new technologies and ensure timely product launches.
• Continuously monitor GMP, EU, and FDA regulatory changes and requirements.
• Provide 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 collaboration with local and global MSAT networks to define and implement new technical standards.
• Ensure internal and external benchmarking to stimulate and extend knowledge 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.

Required Experience : Director

Key Skills

Fundraising, Management Experience, Coaching, Analysis Skills, Strategic Planning, Team Management, Budgeting, Leadership Experience, Mentoring, Public Speaking, Negotiation, Supervising Experience

Employment Type : Full-Time

Experience : years

Vacancy : 1