Scientist II, Biopharmaceuticals (GMP)

Thermo Fisher Scientific•Middleton, WI

2d•Onsite

About The Position

The Scientist II, Biopharmaceuticals role is a fully onsite position at Thermo Fisher Scientific’s GMP Laboratory in Middleton, Wisconsin. The scientist works in a multifunctional environment supporting drug development and collaborates with cross-functional teams through innovation, partnership, and creative problem-solving. The role 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. It also involves operating and troubleshooting analytical instruments, maintaining accurate laboratory documentation, reviewing results against SOP acceptance criteria, independently managing QC responsibilities, completing quality-assurance-facing tasks, authoring low-complexity quality records, and participating in OOS/OOT/atypical investigations. Applicants must be legally 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.
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 work collaboratively and contribute to a cohesive, productive team.
Legal authorization to work in the United States without sponsorship.
Ability to pass a comprehensive background check, including drug screening.
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 proficiently.
Ability to work under pressure while prioritizing and handling multiple projects or activities.

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 to quantitatively measure pharmaceutical and biopharmaceutical compounds in various 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 from assignments and make initial determinations of acceptability according to SOP acceptance criteria.
Perform work assignments accurately, safely, and on time.
Independently manage QC responsibilities.
Communicate project status to the project leader, 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.
Cross-train on sample preparation techniques with another laboratory group.