Senior Scientist - Technical Project Manager - HPLC & CE

Thermo Fisher Scientific - Middleton, WI

Full-time - Senior

Middleton, WI

Computer and Electronic Product Manufacturing

About the position

The Senior Scientist - Technical Project Manager at Thermo Fisher Scientific is responsible for leading complex laboratory analyses of pharmaceutical products, utilizing analytical instrumentation, and ensuring compliance with industry standards. This role involves project leadership, client interaction, data evaluation, and the preparation of technical documents, all aimed at improving patient health outcomes through scientific excellence.

Responsibilities

• Perform complex laboratory analysis of pharmaceutical products using analytical instrumentation.
• Act as the project leader on multiple projects, interacting with clients and reviewing data.
• Write reports and protocols, ensuring scientific conduct and communication of regulatory issues.
• Independently perform method validations, method transfers, and analytical testing of pharmaceutical compounds.
• Prepare study protocols, project status reports, and final study reports.
• Communicate data and technical issues to clients and respond to their needs.
• Mentor and train laboratory team members, assisting in troubleshooting instrument and analytical problems.
• Assist with quality systems and new equipment.
• Design method validation or transfer protocols and establish project timelines.
• Review, interpret, and analyze data for compliance with protocols, methods, and regulatory standards.

Requirements

• Bachelor's degree or equivalent in a relevant field.
• 5+ years of relevant experience in laboratory analysis and project management.
• Solid understanding of general chemistry and separation science.
• Experience with HPLC and CE techniques.
• Knowledge of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements, and FDA guidance.
• Proficiency in Microsoft Excel and Word.
• Strong problem-solving and troubleshooting abilities.
• Effective oral and written communication skills.
• Proven technical writing skills.
• Time management and project management skills.
• Ability to work collaboratively in a team environment.
• Ability to train junior staff.