Thermo Fisher Scientific

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

Italy

Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical ManufacturingIndustries

Position Overview

  • Location Type: Remote (EU/US)
  • Job Type: Full time
  • Work Schedule: Standard Office Hours (40/wk)
  • Environmental Conditions: Office

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.

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.

Skills

Isolator Technology
Aseptic Pharmaceutical Processes
Decontamination Cycles
Environmental Monitoring
Cycle Development
Troubleshooting
Root Cause Analysis
GMP
EU Regulations
FDA Regulations
Validation
Sterilization
IQ/OQ/PQ Equipment Qualification
Technical Standards Development

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.
Sale of anatomical pathology business could create a temporary product gap.
Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.
Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.
They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.
Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.
Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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