Scientist - Analytical Development (HPLC, GC, LCMS, DSC, TGA, KF, FTIR, NMR)

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Scientist - Analytical Development

Your Role:

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 members

• Develop test methods for Process Development (PD) products, intermediates, and raw materials

• Initiate documentation and methodologies needed to support cGMP manufacturing

• Work 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 instruments

• Troubleshoot HPLC, GC, LCMS, DSC, TGA, KF, FTIR, NMR and XRPD, among other instrumentation, and wet chemical assays is essential

• Properly document and review group members lab work

• 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 NMR, MS, FTIR)

• 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

• Regular use of phones, computers, computer monitors, and all office / laboratory equipment

• The 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 unassisted

• Job involves use of close vision, distance vision, color vision, peripheral vision, depth vision

• Wear 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 discipline

• 5+ years of experience in an cGMP or GLP analytical laboratory environment

OR

• Master’s Degree in Chemistry, Chemical Engineering, or other Life Science discipline

• 2+ years of experience in an cGMP or GLP analytical laboratory environment

OR

• PhD 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 environment

• Experience working in an analytical testing lab with hazardous and toxic chemicals

• Superior technical writing skills to generate development reports