Tech Transfer Scientist - Technical Ops

1w1 week ago

Merck KGaA, Darmstadt, Germany

Madison, US · Full-time · $74,500 – $121,700

About this role

Ready to explore, break barriers, and discover more? At MilliporeSigma, the Tech Transfer Scientist provides objective oversight of process transfer and scale-up activities to ensure safe and effective technology transfer from process development to manufacturing. Review procedures provided by customers and develop plans for chemical process execution at desired scale.

Ensure materials, equipment, and methods are suitable for cGMP manufacture and CFR compliance. Provide necessary information to the technical writing team for master batch records and review them for accuracy. Train employees on equipment, procedures, and techniques to support successful process transfer.

Lead project teams and manage 2-3 concurrent production projects as the technical point of contact for Technical Operations. Collaborate with management on development and implementation of innovative technologies. Participate in client meetings and deliver comprehensive technical transfer reports for internal and external use.

Provide production support for first-time GMP and commercial API processes while ensuring compliance with FDA, OSHA, EPA, DOT, DNR, and other regulatory requirements. Contribute to regulatory filings and responses as part of the technical regulatory support team. Represent the Technical Operations group in leadership functions in the absence of the manager.

Requirements

Bachelors Degree in Chemistry, Biochemistry, Chemical Engineering, or other Life Science discipline
4+ years experience in chemical manufacturing
Experience in API manufacturing
Experience in production in fixed equipment of 200 L or larger
Experience in handling High-Potency APIs
Experience with multiple step chemical syntheses and thorough understanding of organic chemistry
Experience with scaling process from gram quantities to multi-kilogram quantities
Knowledge and understanding of the overall goals, implementation and application of cGMP and other relevant quality systems

Responsibilities

Lead project teams and manage 2-3 concurrent production projects, serving as the technical point of contact for Technical Operations
Collaborate with management on development and implementation of innovative technologies
Independently complete projects or engage subject matter experts to resolve technical challenges
Participate in client meetings and deliver comprehensive technical transfer reports for both internal and external use
Provide production support for first-time GMP and commercial API processes
Develop and execute procedures for continuous process monitoring in production
Lead technology and documentation transfer, author and train staff on batch records, SOPs, and operating procedures
Ensure compliance with FDA, OSHA, EPA, DOT, DNR, and other regulatory requirements while maintaining accurate cGMP documentation