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.), Warehouse

Job 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