Scientist - Analytical Development

The Scientist Analytical Development plays a pivotal role in coordinating the analytical aspect of incoming and ongoing projects for Millipore Sigma-Madison.

This role involves utilizing state-of-the-art instrumentation to develop methodologies and analyze active pharmaceutical ingredients and synthetic intermediates.

The Scientist contributes to discussions and communications with customers to achieve a desired project endpoint. Additionally, they are responsible for documenting methodologies needed to support the project in cGMP manufacturing, troubleshooting instrumentation, and generating compiling results to solve or diagnose a problem.

The Scientist is task with developing or overseeing the development analytical methods to support Process and Analytical Development (PAD), ultimately for 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 the subject matter expert (SME) 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.

Specific responsibilities include : Independently lead project teams, provide guidance, and assist in the development of other group membersDevelop test methods for Process Development (PD) products, intermediates, and raw materialsInitiate documentation and methodologies needed to support cGMP manufacturingWork in the scope of the project independently and in a group setting Testing will involve the use of HPLC, GC, LCMS, DSC, TGA, KF, FTIR, NMR, and XRPD among other tests and instrumentsTroubleshoot HPLC, GC, LCMS, DSC, TGA, KF, FTIR, NMR and XRPD, among other instrumentation, and wet chemical assays is essentialProperly document and review group members lab workManage and prioritize daily and project activitiesSuggest specifications for final products, intermediates, and raw materialsTransfer analytical test methods to Quality ControlTrain Analytical and Quality Control personnel in operation of analytical equipment and methodsWrite and evaluate reports, protocols, SOP’s, and other documentationWork with clients (internal and external) to achieve project goalsInterpretation of analytical data (including NMR, MS, FTIR)Maintain and calibrate / verify analytical and related equipmentProactively consider impact of quality, regulatory, manufacturing, and safety requirements when planning activitiesWork in a safe manner and maintain the cleanliness of the work environmentWork in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelinesRegular use of phones, computers, computer monitors, and all office / laboratory equipmentThe employee will also utilize computer keyboard and can read CRTS / computer monitors Physical Attributes : Regularly sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch, or crawl for long periods of time Use all human senses (speak, hear, smell) Lift or push up to 50 pounds unassistedJob involves use of close vision, distance vision, color vision, peripheral vision, depth visionWear appropriate (PPE) while working around mechanical parts and hazardous material(hard hats, glasses / goggles, chemical resistant suites, gloves, safety shoes, respirator) Who You Are : Minimum Qualifications : Bachelor’s Degree in Chemistry, Chemical Engineering, or other Life Science discipline5+ years of experience in an cGMP or GLP analytical laboratory environmentORMaster’s Degree in Chemistry, Chemical Engineering, or other Life Science discipline2+ years of experience in an cGMP or GLP analytical laboratory environmentORPhD in Chemistry, Chemical Engineering, or other Life Science discipline Preferred Qualifications : Excellent written and verbal communication skills Excellent documentation practices and attention to detail Ability to excel in a team environmentExperience working in an analytical testing lab with hazardous and toxic chemicalsSuperior technical writing skills to generate development reports