Provides strategic, technical, and operational leadership for the Manufacturing Science & Technology (MSAT) documentation function, ensuring the consistent application of cGMP requirements and documentation standards across technology transfers, new product introductions (NPI), process changes, and commercial manufacturing operations.
The base salary hiring range for this position is $133,920 - $150,660 plus eligibility for annual performance bonus.
- Establish and govern site and segment-wide MSAT documentation strategies, standards, and processes to support technology transfer, new product introduction (NPI), process validation, commercial manufacturing, and regulatory compliance.
- Provide strategic, technical, and operational leadership for the Technical Documentation function, ensuring consistent application of cGMP requirements and documentation best practices across the organization.
- Lead the development, review, approval, implementation, and lifecycle management of Master Batch Records (MBRs), manufacturing procedures, specifications, technical reports, and other controlled GMP documentation.
- Serve as the segment subject matter expert and technical authority for manufacturing documentation, providing guidance to MSAT, Manufacturing, Quality, Engineering, Validation, Regulatory Affairs, and Project Management teams.
- Direct documentation activities supporting technology transfers, process scale-up, process validation, new product introductions, and commercial manufacturing readiness.
- Bachelor’s degree in Life Sciences discipline
- paid time off
- health insurance
- dental
- vision
- flexible spending account
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