Scientist II – Biosafety Testing

Thermo Fisher Scientific•Middleton, WI

8d•Onsite

About The Position

The Scientist II works in Thermo Fisher Scientific’s Biosafety Department in a fully onsite GMP laboratory in Middleton, Wisconsin. The role supports drug development in a multifunctional environment and collaborates with cross-functional teams, using innovation, partnership, problem-solving, and laboratory technology to deliver accurate, high-quality results. Applicants must be legally authorized to work in the United States without sponsorship and pass a comprehensive background check that includes drug screening. Relocation assistance is not provided. The Scientist II performs routine to complex sample preparation and analysis to quantitatively measure pharmaceutical and biopharmaceutical compounds in formulations and biological matrices for stability and analytical testing. The position includes independent QC responsibilities, equipment troubleshooting, accurate laboratory documentation, review of results, communication of project status, and participation in quality and investigation processes. The work is performed in a GMP laboratory and may involve exposure to potentially hazardous elements, including infectious agents.

Requirements

Bachelor’s degree in laboratory sciences, such as chemistry, biochemistry, or a similar field.
At least 2 years of comparable experience providing the knowledge, skills, and abilities to perform the job.
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 an effective team.
Ability to communicate, receive, and understand information and ideas with diverse groups in a comprehensible and reasonable manner.
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.
Must be legally authorized to work in the United States without sponsorship and pass a comprehensive background check, including drug screening.

Nice To Haves

Previous experience working with and maintaining cell lines and cell cultures, and performing complex, multi-step assays.

Responsibilities

Train on routine operation, maintenance, and theory of analytical instrumentation, as well as 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 according to SOP acceptance criteria.
Complete work accurately, on time, and safely.
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, and atypical investigations.
Cross-train on sample preparation techniques with another laboratory group.