Scientist II, Biopharmaceuticals (GMP)

About the role

As a Scientist you will work in a multi‑functional environment supporting drug development and collaborate in cross‑functional teams. You will accomplish our mission through innovation and partnership, creative problem‑solving, and use of state‑of‑the‑art technology. At Thermo Fisher Scientific you’ll discover meaningful work that makes a positive impact on a global scale, enabling customers to make the world healthier, cleaner and safer. This is a fully onsite role based at our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the U.S.; relocation assistance is not provided and any relocation costs are the responsibility of the candidate. You must be legally authorized to work in the United States without sponsorship and able to pass a comprehensive background check, which includes a drug screening.

Responsibilities

• Trains on routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines.
• Performs a variety of routine to complex sample preparation and analysis procedures with minimal supervision/guidance to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing.
• Completes all laboratory documentation in clear and accurate language and according to SOP and GLPs.
• Independently troubleshoots equipment & instruments.
• Mentors others in troubleshooting when applicable.
• Reviews and complies results from assignments and makes initial determination on acceptability per SOP acceptance criteria.
• Performs work assignments accurately, and in a timely and safe manner.
• Independently manages QC responsibilities.
• Communicates project status to project leader and helps to identify gaps and anticipates roadblocks in project team workflow.
• Completes QA‑facing tasks with minimal supervisor/QA input.
• Authors low complexity quality records and participates in the OOS/OOT/Atypical investigation process.

Requirements

• Bachelor's degree in lab sciences such as chemistry, biochemistry, or similar.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’). Years of experience refer to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job; they are not the sole determining factor for job class or selection.
• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.
• Adherence to all Good Manufacturing Practices (GMP) safety standards.
• Work setting includes