Operations Process Leader

Thermo Fisher Scientific · Plainville, MA

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Manufacturing OperationsFull timeCompany career page

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Role summary

Scientist III position in formulation at a biopharmaceutical manufacturing facility. Manage technical projects, develop and optimize formulation processes, ensure GMP compliance, and collaborate with cross-functional teams to deliver high-quality biopharmaceutical products.

What they're looking for

Advanced degree plus 3 years experience, or bachelor's degree plus 5 years in biopharmaceutical manufacturing
Background in chemistry, biochemistry, biology, biotechnology, or chemical engineering
Strong understanding of GMP regulations and quality systems
Expertise in process validation, risk assessments, and process control strategies
Proficiency in manufacturing documentation systems, batch record review, and technology transfer
Experience with SAP, LIMS, or related software systems
Project management, analytical problem-solving, and cross-functional collaboration skills

What you'll be doing

Develop, optimize, and conduct validation studies for biopharmaceutical formulation processes
Manage technical projects and provide manufacturing support while ensuring GMP compliance
Resolve complex process challenges and perform risk assessments and scale-up activities
Work with clients and internal teams on batch record review and documentation
Lead process improvements using Lean Manufacturing and Six Sigma methodologies

Compensation$83,300–$125,000 base

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