Senior Scientist - Technical Project Manager - GMP

Thermo Fisher Scientific - Middleton, WI

Full-time - Senior

Middleton, WI

10,001+ employees

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 while ensuring compliance with industry standards. This role involves project leadership, client interaction, and the scientific conduct of projects, with a focus on delivering quality and accuracy in laboratory services. The position requires a strong understanding of laboratory protocols and the ability to mentor junior staff, making a significant impact on patient health through innovative scientific solutions.

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 implementation.
• Design method validation or transfer protocols and establish project timelines.
• Review, interpret, and analyze data for compliance with protocols and Good Manufacturing Practices (GMP).

Requirements

• Bachelor's degree or equivalent in a relevant field.
• 5+ years of experience in a related role, with a strong understanding of general chemistry and separation science.
• Knowledge of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements, and FDA guidance.
• Proficiency in Microsoft Excel and Word, and technical operating systems.
• Effective oral and written communication skills, with proven technical writing abilities.
• Strong time management and project management skills.
• Ability to work collaboratively in a team environment and train junior staff.

Nice-to-haves

• Experience with Good Laboratory Practices (GLP).
• Familiarity with laboratory safety protocols and handling hazardous materials.

Benefits

• Health insurance coverage
• 401k retirement savings plan
• Paid holidays
• Flexible scheduling options
• Professional development opportunities