Thermo Fisher Scientific - Middleton, WI

posted 14 days ago

Full-time - Mid Level
Middleton, WI
5,001-10,000 employees
Computer and Electronic Product Manufacturing

About the position

The Scientist III - Technical Project Manager role at Thermo Fisher Scientific is designed for a Senior Scientist with a focus on managing technical projects related to routine and stability work in a clinical laboratory setting. This position involves performing complex laboratory analyses, leading multiple projects, and ensuring compliance with industry standards while contributing to the development of life-changing therapies.

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.
  • Design and drive experiments with minimal supervision, preparing study protocols and project status reports.
  • Mentor and train junior staff, coordinating laboratory activities and troubleshooting issues.
  • Assist with quality systems and new equipment, designing method validation protocols and establishing project timelines.
  • Review, interpret, and analyze data for compliance with protocols, methods, and Good Manufacturing Practices (GMP).
  • Conduct self and peer reviews of data for accuracy before submission to QA.

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, including technical writing skills.
  • Time management and project management skills.
  • Ability to work collaboratively in a team environment.

Nice-to-haves

  • Experience with laboratory quality systems and compliance standards.
  • Familiarity with clinical trial processes and regulatory requirements.

Benefits

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