|Date Posted||May 13, 2021|
|Address||645 Science Drive|
A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
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 will be competent in cGMP manufacture of APIs, project leadership, project planning and resource allocation.
- Work within a team environment and serve as a Project Team Leader
- Provide input to Management regarding the development and implementation of newly innovative technologies
- Simultaneous management of 2-3 production projects at various states of maturity
- Ability to complete projects independently or to engage the appropriate subject matter experts to resolve concerns
- Participation in project team meetings with clients
- Provide innovative solutions to address current technical challenges for the commercial manufacture of APIs
- Take a leading role in production support for both first time GMP and commercial processes
- Development and execution of procedures to support continuous process monitoring in production
- Lead technology and documentation transfer and implementation of the process and serve as the technical point of contact for the Technical Operations function
- Deliver comprehensive technical transfer reports to clients and for internal use
- Author, utilize, and train employees on a wide variety of written procedures, including batch records and operating procedures
- Work in accordance with FDA, OSHA, EPA, DNR, DOT and other regulatory agency guidelines
- Maintain accurate and concise cGMP records
- Support regulatory filings and justifications as a member of the technical regulatory response team
Who you are:
- Bachelors Degree in Chemistry, Bio Chemistry, Biology or other Life Science.
- 2+ years experience in chemical manufacturing.
- Masters Degree in Chemistry or other related Scientific discipline
- 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.