Scientist II, Cell Lab (Tuesday - Saturday)

Thermo Fisher Scientific•Middleton, WI

2d•Onsite

About The Position

The Scientist II works in Thermo Fisher Scientific’s PPD Laboratory Services Cell Lab, supporting drug development in a multifunctional, collaborative environment. The role performs sample preparation and analytical testing of pharmaceutical and biopharmaceutical compounds in formulations and biological matrices, and supports stability and analytical testing. The position is fully onsite at a GMP laboratory in Middleton, Wisconsin, and follows a Tuesday–Saturday, first-shift schedule during standard office hours (40 hours per week). Relocation assistance is not provided. Applicants must be legally authorized to work in the United States without sponsorship and pass a comprehensive background check, including drug screening. The role requires accurate and timely laboratory work, clear documentation in accordance with SOPs and GLPs, independent equipment troubleshooting, QC management, and communication of project status and potential workflow issues. The Scientist II also completes QA-facing tasks, authors low-complexity quality records, participates in OOS/OOT/atypical investigations, and may cross-train with another laboratory group. The work takes place in a GMP laboratory and office environment, with possible exposure to potentially hazardous elements, including infectious agents, and use of PPE.

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 analytical instrumentation operation, maintenance, and theory, as well as 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 productive team.
Ability to communicate, receive, and understand information and ideas with diverse groups of people.
Ability to work upright and stationary and/or standing for typical working hours.
Ability to lift and move objects up to 25 pounds.
Ability to work in non-traditional work environments and use and learn standard office equipment and technology.
Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Legal authorization 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 for stability and analytical testing.
Complete laboratory documentation clearly and accurately in accordance with SOPs and GLPs.
Independently troubleshoot equipment and instruments, and mentor others in troubleshooting when applicable.
Review and compile results and make initial determinations of acceptability against SOP acceptance criteria.
Complete work assignments accurately, safely, and on time.
Independently manage QC responsibilities.
Communicate project status to the project leader and help identify gaps and anticipate workflow roadblocks.
Complete QA-facing tasks with minimal supervisor or QA input.
Author low-complexity quality records and participate in OOS/OOT/atypical investigations.
Cross-train on sample preparation techniques with another laboratory group when applicable.