Scientist II, Cell Lab (GMP)
About The Position
The Scientist II works in Thermo Fisher Scientific’s Cell Lab in a multifunctional GMP laboratory environment, supporting drug development and collaborating with cross-functional teams. The role uses innovation, partnership, creative problem-solving, and advanced technology to support analytical testing and improve patient health. The position performs routine to complex sample preparation and analysis of pharmaceutical and biopharmaceutical compounds in formulations and biological matrices for stability and analytical testing. The Scientist II documents work according to SOPs and GLPs, reviews results against SOP acceptance criteria, independently manages quality-control responsibilities, troubleshoots instruments, completes quality-assurance tasks, and contributes to quality records and investigations. This is a fully onsite, first-shift role in Middleton, Wisconsin, scheduled Monday through Friday. Applicants must be authorized to work in the United States without sponsorship and must pass a comprehensive background check, including drug screening. Relocation assistance is not provided.
Requirements
- Bachelor’s degree in laboratory sciences, such as chemistry, biochemistry, or a similar field.
- Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 2 or more years of related experience.
- Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines.
- Knowledge of applicable regulatory authorities, compendia, and ICH guidelines.
- Excellent manual dexterity for precise and accurate work.
- Strong written and oral communication skills.
- Strong time-management and project-management skills.
- Problem-solving and troubleshooting abilities.
- Ability to work collaboratively and contribute to a cohesive team.
- Ability to demonstrate behaviors aligned with Thermo Fisher Scientific’s 4i Values.
- Legally authorized to work in the United States without sponsorship.
- Ability to pass a comprehensive background check, including drug screening.
Nice To Haves
- Demonstrated experience with cell biology, molecular biology, and immunoassay techniques such as cell culture, ELISA, and PCR.
Responsibilities
- Train on routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines.
- Perform routine to complex sample preparation and analysis with minimal supervision to quantitatively measure pharmaceutical and biopharmaceutical compounds in formulations and biological matrices.
- Complete laboratory documentation clearly and accurately according to SOPs and GLPs.
- Independently troubleshoot equipment and instruments, and mentor others in troubleshooting when applicable.
- Review and compile assignment results and make initial determinations of acceptability according to SOP acceptance criteria.
- Perform work accurately, safely, and in a timely manner.
- Independently manage QC responsibilities and communicate project status to the project leader.
- Help identify gaps and anticipate roadblocks in project-team workflow.
- Complete QA-facing tasks with minimal supervisor or QA input.
- Author low-complexity quality records and participate in OOS/OOT/Atypical investigations.
- Collaborate with cross-functional teams and cross-train on sample-preparation techniques with another laboratory group.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
