|Date Posted||May 13, 2021|
|Address||645 Science Drive|
A Scientist in the Analytical Development group is responsible for the coordination of the analytical aspect of incoming and existing projects for the MilliporeSigma Madison. This includes but is not limited to use of state-of-the-art instrumentation to develop methodologies for the analysis of 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 cGMP manufacturing, troubleshooting instrumentation, and generating and compiling results to solve or diagnose a problem.
Use and troubleshoot HPLC, GC, DSC, TGA, KF, IR, MS, 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. The Scientist is responsible for reviewing and evaluating analytical data for identification of products, intermediates and raw materials as well as troubleshooting and guiding development. The Scientist is responsible for maintaining project timing and interacting with clients to assure project goals are met in an efficient and well documented manor.
Working with colleagues in PAD, the Scientist is part of a team of professionals advancing pharmaceutical candidates to cGMP manufacturing. The Scientist is an expert in analytical chemistry and the requirements for cGMP manufacturing. Executes and troubleshoots 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.
Essential Job Functions:
- Independently lead project teams, provide guidance and oversee other group members.
- Develop test methods for Process and Analytical Development (PAD) 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 PAD final products, intermediates and raw materials. Testing will involve the use of HPLC, GC, DSC, TGA, KF, IR, MS, 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 FT-IR, NMR, MS).
- 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:
- Bachelors degree in Chemistry, Biochemistry or related biological sciences AND 5+ years of experience in an analytical laboratory environment operating under GLP or cGMP conditions.
- Masters degree in Chemistry, Biochemistry or related biological sciences AND 2+ years of experience
- PhD in Chemistry, Biochemistry or related biological sciences AND 0+ years of experience in an analytical laboratory environment operating under GLP or cGMP conditions.
- 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.