Role at a glance
- Salary
- Not Disclosed
- Location
- Warrington (KG), United Kingdom
- Work arrangement
- On-site
- Employment
- Full-time
- Experience
- Senior Level Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in biopharmaceutical/diagnostic manufacturing, process development, or related technical operations
- Education
- Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience
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Role Summary
This senior role focuses on product development and commercialization in manufacturing sciences, with responsibility for manufacturing quality, process validation, and regulatory compliance. The position involves working with diverse teams on CMC strategies and process improvements for therapies and diagnostic solutions.
What You'll Do
- Develop and implement CMC strategies
- Ensure manufacturing quality, process validation, and regulatory compliance
- Standardize procedures and guide process improvements
- Influence technical operations and mentor colleagues
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Requires an advanced degree with 6 years or a bachelor's degree with 8 years of manufacturing or technical operations experience, plus GMP, validation, and regulatory expertise.
Required
- Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in biopharmaceutical/diagnostic...
- Expertise in CMC strategy, process validation, and regulatory compliance (FDA/EMA)
- Strong understanding of GMP, GLP, and quality systems
- Experience in project management and cross-functional team leadership
- Experience with process optimization and troubleshooting in regulated environments
- Advanced knowledge of industry standards and regulatory requirements
- Excellent analytical and problem-solving capabilities
- Strong technical writing and presentation skills
Preferred
- Preferred Fields of Study: Engineering, Life Sciences, Chemistry, Biochemistry, or related scientific field
- Additional relevant certifications in GMP, regulatory compliance, or project management valued
Original job description
Content provided by the employer
Original job description
Content provided by the employer
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), WarehouseJob Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.DESCRIPTION:
Join our team as a Senior Staff Scientist in Manufacturing Sciences, where you'll contribute to innovation and excellence in product development and commercialization. You'll play an important role in ensuring manufacturing quality, process validation, and regulatory compliance. Working with diverse teams, you'll develop and implement CMC strategies, standardize procedures, and guide process improvements that directly impact the production of life-changing therapies and diagnostic solutions. This position offers the opportunity to influence technical operations, mentor colleagues, and contribute to our mission of enabling customers to make the world healthier, cleaner, and safer.
REQUIREMENTS:
• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in biopharmaceutical/diagnostic manufacturing, process development, or related technical operations
• Preferred Fields of Study: Engineering, Life Sciences, Chemistry, Biochemistry, or related scientific field
• Additional relevant certifications in GMP, regulatory compliance, or project management valued
• Expertise in CMC strategy, process validation, and regulatory compliance (FDA/EMA)
• Strong understanding of GMP, GLP, and quality systems
• Experience in project management and cross-functional team leadership
• Experience with process optimization and troubleshooting in regulated environments
• Advanced knowledge of industry standards and regulatory requirements
• Excellent analytical and problem-solving capabilities
• Strong technical writing and presentation skills
• Demonstrated ability to influence and collaborate in a matrix organization
• Proficiency in statistical analysis and experimental design
• Ability to manage multiple projects simultaneously
• Strong interpersonal and communication skills
• Travel up to 25-30% as required
• Experience with risk assessment and mitigation strategies
• Ability to train and mentor technical staff
• Ability to adapt to changes in manufacturing environment
About the company
Thermo Fisher Scientific
Large Enterprise
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.