Tech Transfer Scientist, Technical Ops

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Merck Group, onsite in Madison, WI, is seeking a Tech Transfer Scientist in Technical Ops to oversee process transfer and scale up from development to GMP manufacturing, ensuring cGMP and CFR compliance. You will review customer procedures, develop execution plans for the desired scale, generate master batch records, train staff, and may represent Technical Operations in leadership settings. Expect to lead two to three concurrent projects, collaborate on innovative technologies, and deliver transfer reports for internal and external use while supporting first-time GMP and commercial API production. Requirements include a bachelor’s degree in chemistry or a related field and four or more years of chemical manufacturing; preferred API manufacturing, 200 L plus equipment, HPAPI, and strong communication. Salary $74,500-$121,700; no visa sponsorship; applicants must be eligible to work in the US. Apply with a resume that highlights API tech transfer, scale-up successes, multi-project leadership, regulatory experience, and training accomplishments; demonstrate fluency with data tools like MS Office and ChemOffice.

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

Your Role:

At MilliporeSigma, the Tech Transfer Scientist is responsible for providing objective oversight of process transfer and scale up activities to ensure safe and effective technology transfer from process development to manufacturing. This individual will review and provide feedback on procedures provided by customers (both internal and external) and develop a plan for the execution of a chemical process at the desired scale, ensuring that materials, equipment and methods are suitable and appropriate for cGMP manufacture and CFR compliance. This individual will provide all necessary information to the technical writing team for generation of master batch records and will review these master batch records for accuracy to ensure successful process transfer. The Tech Transfer Scientist will also be responsible for training employees on equipment, procedures and techniques and may also be asked to represent the Technical Operations group in leadership functions in the absence of the manager. The Tech Transfer Scientist must be competent in cGMP manufacture of APIs, project leadership, project planning and resource allocation.

• 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.
• Contribute to regulatory filings and responses as part of the technical regulatory support team.

Who You Are

Minimum Qualifications:

• Bachelors Degree in Chemistry, Biochemistry, Chemical Engineering, or other Life Science discipline.
• 4+ years experience in chemical manufacturing.

Preferred Qualifications:

• Experience in API manufacturing.
• Experience in production in fixed equipment of 200 L or larger.
• Experience in handling High-Potency APIs is a plus.
• Experience with multiple step chemical syntheses and thorough understanding of organic chemistry.
• Experience with scaling process from gram quantities to multi-kilogram quantities.
• Scientific problem-solving skills, including the ability to identify critical issues in experimental work and to suggest possible solutions.
• Knowledge and understanding of the overall goals, implementation and application of cGMP and other relevant quality systems.
• Superior organizational skills and the ability to multi-task proficiently.
• Excellent communication skills, including the ability to give presentations and to speak to large groups. The ability to establish rapport with non-technical parts of the company as well.
• Proficient in use of standard office computers as well as software for laboratory work (data capture, data analysis, etc.) and statistical analysis. Specifically, MS Office 365, MS Project, ChemOffice, etc. 

Pay Range for this position: $74,500-$121,700 per year.

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

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