Senior Scientist, Process Development

The businesses of Merck KGaA, Darmstadt, Germany•Madison, WI

2d•Onsite

About The Position

MilliporeSigma in Madison, WI, is looking for a Senior Scientist in Process Development. This role is a laboratory-based position within a business-oriented process development and manufacturing setting. The department primarily focuses on developing synthetic and analytical platforms for the production of Active Pharmaceutical Ingredients (APIs). Scientists in this role will be expected to contribute to the innovative development and implementation of technical projects within the collaborative MilliporeSigma team environment.

Requirements

PhD in Organic Chemistry, Chemistry or other Scientific discipline
Master’s degree in Organic Chemistry, Chemistry or other Scientific discipline with 3+ years of experience in process chemistry
Bachelor’s degree in Organic Chemistry, Chemistry or other Scientific discipline with 5+ years of experience in process chemistry

Nice To Haves

PhD in Organic Chemistry with 1-2 years of experience in industry, including process chemistry and regulatory experience
Experience supporting a commercial program
Experience in handling High-Potency APIs
Knowledge of experimental design techniques and thermal hazard evaluation techniques in the process development field
Superior organizational skills and the ability to multi-task proficiently
Excellent communication skills, including the ability to give presentations and to speak to large groups. The ability to establish rapport with non-technical parts of the company as well.
Proficient in use of standard office computers as well as software for laboratory work (data capture, data analysis, etc.) and statistical analysis. Specifically, MS Office 365, MS Project, ChemOffice, etc.

Responsibilities

Design and lead the development of robust processes for manufacturing pharmaceutical intermediates and APIs, ensuring compliance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines.
Develop successful processes through hands-on lab work while overseeing the efforts of junior scientists, mentoring them in the Process and Analytical Development (PAD) organization.
Act as the technical team leader, participating in all project team activities and simultaneously managing 2-3 projects at various stages of maturity.
Demonstrate a thorough understanding of modern analytical techniques to interpret spectra and data, providing innovative solutions to technical and analytical challenges during process development and cGMP manufacturing.
Oversee process transfer to production labs, providing technical support for troubleshooting activities, process validation, and post-validation efforts.
Prepare comprehensive process development reports for clients and internal use, ensuring effective documentation of process development activities.
Display strong customer-facing communication skills to instill client confidence and demonstrate effective written communication skills.
Act as a consultant for process and analytical development issues, completing projects with minimal guidance and proactively considering quality, regulatory, manufacturing, and safety requirements in project planning.
Author, utilize, and train employees on written procedures, including batch records and operating procedures, while adequately documenting experimental data in electronic formats.
Actively participate in or lead initiatives within PAD and the organization, showcasing scientific problem-solving skills and the ability to identify critical issues in experimental work.