Scientist - Analytical Development

Merck KGaA Darmstadt Germany - Madison, WI

Full-time

Madison, WI

Chemical Manufacturing

About the position

The Scientist - Analytical Development at MilliporeSigma plays a crucial role in coordinating the analytical aspects of projects, utilizing advanced instrumentation to develop methodologies and analyze pharmaceutical ingredients. This position involves collaboration with customers to achieve project goals, documentation for cGMP manufacturing, troubleshooting instrumentation, and generating results to address problems.

Responsibilities

• 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 independently and in a group setting within the project scope
• Test using HPLC, GC, LCMS, DSC, TGA, KF, FTIR, NMR, and XRPD among other tests and instruments
• Troubleshoot HPLC, GC, LCMS, DSC, TGA, KF, FTIR, NMR, and XRPD instrumentation and wet chemical assays
• Document and review lab work of group members
• 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, SOPs, and other documentation
• Work with clients (internal and external) to achieve project goals
• Interpret analytical data (including NMR, MS, FTIR)
• Maintain and calibrate/verify analytical and related equipment
• Consider quality, regulatory, manufacturing, and safety requirements when planning activities
• Maintain a safe and clean work environment
• Comply with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines

Requirements

• Bachelor's Degree in Chemistry, Chemical Engineering, or other Life Science discipline with 5+ years of experience in a cGMP or GLP analytical laboratory environment
• OR Master's Degree in Chemistry, Chemical Engineering, or other Life Science discipline with 2+ years of experience in a cGMP or GLP analytical laboratory environment
• OR PhD in Chemistry, Chemical Engineering, or other Life Science discipline

Nice-to-haves

• Excellent written and verbal communication skills
• Excellent documentation practices and attention to detail
• Ability to excel in a team environment
• Experience working in an analytical testing lab with hazardous and toxic chemicals
• Superior technical writing skills to generate development reports