Scientist - Analytical Development

Merck•Madison, WI

2d•Onsite

About The Position

A Scientist in the Analytical Development group will coordinate the analytical aspect of incoming and existing projects for MilliporeSigma-Madison. 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. The Analytical Scientist will develop, or direct the development, of analytical methods to support Process and Analytical Development (PAD) for eventual validation and or use in cGMP. The Analytical Scientist will review and evaluate analytical data for identification of products, intermediates, and raw materials as well as troubleshooting and guiding development. The Analytical Scientist will maintain project timing and interact with clients to assure project goals are met in an efficient and well documented manor. Working with colleagues in PAD, the Analytical Scientist is part of a team of professionals advancing pharmaceutical candidates to cGMP manufacturing. The Analytical Scientist is considered an expert 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. The Scientist is recognized as a significant individual contributor in the scientific and technical areas within PAD. Independently lead project teams, provide guidance, and mentor group members.

Requirements

Bachelor’s degree in Chemistry, Biology or other Life Science discipline.
5+ years in an analytical laboratory environment operating under GLP or cGMP conditions.
OR Master’s degree in Chemistry, Biology or other Life Science discipline.
2+ years in an analytical laboratory environment operating under GLP or cGMP conditions.
OR PhD in Chemistry, Biology or other Life Science discipline.

Nice To Haves

Excellent written and verbal communication skills, as well as, excellent documentation practices and attention to detail.
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.

Responsibilities

Develop test methods for PD products, intermediates, and raw materials.
Initiate documentation and methodologies to support cGMP manufacturing.
Solve problems of significant scope both independently and in teams.
Analytically test PD final products, intermediates, and raw materials using methods like HPLC, GC, LCMS, ICPMS, DSC, TGA, KF, FTIR, NMR, and XRPD.
Properly document and review lab work; transfer analytical methods to Quality Control.
Train Analytical and Quality Control personnel in equipment and method operation; manage daily/project priorities.
Ensure compliance with quality, regulatory, manufacturing, and safety requirements; maintain a safe, clean work environment.