Scientist II – Biosafety Testing

Thermo Fisher Scientific•Middleton, WI

10d•Onsite

About The Position

The Scientist II works in the Biosafety department at Thermo Fisher Scientific’s GMP laboratory in Middleton, Wisconsin. This fully onsite role supports drug development in a multifunctional environment and collaborates with cross-functional teams to deliver accurate, high-quality laboratory work using current technology. The position requires legal authorization to work in the United States without sponsorship and successful completion of a comprehensive background check, including drug screening. Relocation assistance is not provided. The Scientist II performs routine to complex sample preparation and analytical testing of pharmaceutical and biopharmaceutical compounds in formulations and biological matrices. The role includes operating and troubleshooting laboratory instruments, maintaining accurate documentation, reviewing results against SOP criteria, managing quality-control responsibilities, completing quality-assurance tasks, and contributing to quality records and investigations. The position also involves working safely in a GMP laboratory, potentially around infectious agents and other hazardous elements, and may require cross-training with another laboratory group.

Requirements

Bachelor’s degree in laboratory sciences, such as chemistry, biochemistry, or a similar field.
Comparable to 2 or more years of relevant 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 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 weighing 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.
Must 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, multistep assays is preferred.

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 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 using SOP acceptance criteria.
Perform work assignments accurately, promptly, and safely.
Independently manage quality-control responsibilities.
Communicate project status to the project leader and help identify gaps and anticipate workflow roadblocks within the project team.
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 needed.
Contribute to a collaborative team and demonstrate behaviors aligned with Thermo Fisher’s 4i Values.