Tech Transfer Scientist, Technical Ops

The businesses of Merck KGaA, Darmstadt, Germany•Madison, WI

About The Position

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.

Requirements

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

Nice To Haves

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.

Responsibilities

Provide objective oversight of process transfer and scale up activities.
Review and provide feedback on procedures provided by customers.
Develop a plan for the execution of a chemical process at the desired scale.
Provide information to the technical writing team for generation of master batch records.
Review master batch records for accuracy.
Train employees on equipment, procedures and techniques.
Represent the Technical Operations group in leadership functions in the absence of the manager.
Lead project teams and manage 2–3 concurrent production projects.
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.