Operations Process Leader
$83.3k - $125kThermo Fisher Scientific
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.
Responsibilities
- 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
Requirements
- 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
Compensation: $83,300–$125,000 base
Vacancy posted 15 days ago
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