Job Id
291018
Madison, Wisconsin, United States
Job Type
Full-time
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
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.
Your Role:
The Sr Associate Scientist – Cleaning Method Development in the Analytical Development group is primarily responsible for developing and helping to develop test methods (primarily HPLC-UV but also HPLC-MS) to be able to detect and quantify low levels of API that may be left in manufacturing equipment after production. This work will also involve spiking coupons with product and determining recovery of the API from them both via rinsate and swab sampling. Once suitable methods are developed, the work will include transfer of the methods to the Quality Control group for use in plant changeover testing and method validation.
Further, depending on work load for cleaning development, this position will also shift to other analytical project support that will include the 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.
You will use and troubleshoot HPLC, GC, LCMS, GCMS, DSC, TGA, KF, FTIR, NMR and XRPD, among other instrumentation, and wet chemical assays is essential. The Sr Associate Scientist will support the development of analytical methods to support Process and Analytical Development (PAD) for eventual validation and or use in cGMP manufacturing. The Sr Associate Scientist will review and evaluate analytical data for identification of products, intermediates and raw materials as well as troubleshooting and guiding development. The Sr Associate Scientist will maintain project timing and interacting with clients to assure project goals are met in an efficient and well documented manner.

Working with colleagues in PAD, the Sr Associate Scientist is part of a team of professionals advancing pharmaceutical candidates to cGMP manufacturing. The Sr Associate Scientist is considered proficient in analytical chemistry and the requirements for cGMP manufacturing. Demonstrates a documented ability to execute and troubleshoot experiments as well as provides sound judgement in scientific and technical situations.

• Assist in the development of methods to test for low level API carryover in manufacturing equipment and to find suitable means for recovery of the API from the surfaces of the manufacturing equipment. Assist in the development of 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 help solve analytical testing 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 lab work
• Manage and prioritize daily and project activities. Properly document lab work. Transfer analytical test methods to Quality Control. Write and evaluate reports, protocols, SOP’s and other documentation
• Work with clients (internal and external) to achieve project goals
• 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:

Minimum Qualifications:

• Bachelor’s Degree in Biology, Chemistry or related Life Science discipline.
• 5+ years in an analytical laboratory environment operating under GLP or cGMP conditions.

Preferred Qualifications:

• 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.

Please refer the Job description for details