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Scientist, Analytical Development - First Shift 1
Posted 02 Feb 2023
Madison, Wisconsin - United States
Req Id 260916
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
A Scientist in the Analytical Development group is responsible for the coordination of the analytical aspect of incoming and existing projects for MilliporeSigma. This includes but is not limited to use of state-of-the-art instrumentation to develop methodologies and analyze active pharmaceutical ingredients as well as the synthetic intermediates, contributing to discussions and communications with customers to achieve a desired endpoint, initiating documentation and methodologies needed to support the project in cGMP manufacturing, troubleshooting instrumentation, and generating and compiling results to solve or diagnose a problem. This position will be using and troubleshooting HPLC, GC, LCMS, DSC, TGA, KF, FTIR, NMR and XRPD, among other instrumentation, and wet chemical assays. The Scientist is responsible for development, or directing the development, of analytical methods to support Process and Analytical Development (PAD) for eventual validation and or use in cGMP. This position is responsible for reviewing and evaluating analytical data for identification of products, intermediates, and raw materials while maintaining project timing and interacting with clients to assure project goals are met in an efficient and well documented manner. While working with colleagues in PAD, the Scientist is part of a team of professionals advancing pharmaceutical candidates to cGMP manufacturing. The Scientist is considered an expert in analytical chemistry and the requirements for cGMP manufacturing while demonstrating a documented ability to execute and troubleshoot experiments as well as provides sound judgement in scientific and technical situations. The Scientist is recognized as a significant individual contributor in the scientific and technical areas within PAD. Additional responsibilities include:
- Independently lead project teams, provide guidance, and assist in the development of other group members
- Develop test methods for Process Development (PD) products, intermediates, and raw materials
- Initiate documentation and methodologies needed to support cGMP manufacturing
- Work on and be able to both: independently and in a group, solve problems of significant scope
- Analytically test PD final products, intermediates, and raw materials. Testing will involve the use of HPLC, GC, LCMS, DSC, TGA, KF, FTIR, NMR and XRPD among other tests and instruments
- Properly document and review group members lab work
- Ability to manage and prioritize daily and project activities
- Suggest specifications for final products, intermediates, and raw materials
- Transfer analytical test methods to Quality Control
- Train Analytical and Quality Control personnel in operation of analytical equipment and methods
- Write and evaluate reports, protocols, SOP’s and other documentation
- Work with clients (internal and external) to achieve project goals
- Interpretation of analytical data (including NMR, MS, FTIR)
- Maintain and calibrate/verify analytical and related equipment.
- Proactively consider impact of quality, regulatory, manufacturing, and safety requirements when planning activities.
- Work in a safe manner and maintain the cleanliness of the work environment
- Work in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines
Who You Are:
- Bachelor’s Degree in Chemistry, Biochemistry, or other Life Science
- 5+ years in an GLP or cGMP analytical laboratory
- Master’s Degree in Chemistry, Biochemistry, or other Life Science
- 2+ years in an GLP or cGMP analytical laboratory
- Ph.D. in Chemistry, Biochemistry, or other Life Science
- Excellent communication skills
- Ability to work in a team environment
- Ability to work in an Analytical testing lab with hazardous and toxic chemicals
- Adequate technical writing skills to generate development reports.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html