Senior Scientist - Technical Project Manager - GMP

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 plays a crucial role in leading complex laboratory analyses of pharmaceutical products. This position involves project leadership, client interaction, and ensuring compliance with regulatory standards. The individual will be responsible for method validations, analytical testing, and mentoring team members, all while contributing to the mission of improving health outcomes globally.

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, train, and coordinate laboratory activities of team members.
• Assist with quality systems and new equipment.
• Design method validation or method transfer protocols and establish project timelines.
• Review, interpret, and analyze data for compliance with protocols, methods, and regulations.

Requirements

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