Scientist II - GMP, Cell & Gene Therapy

Schedule

First Shift (Days)

Location & Work Authorization

This is a fully onsite role based at our GMP Laboratory in Middleton, WI. Relocation assistance is not provided; any relocation costs are the candidate’s responsibility. Candidates must be legally authorized to work in the United States without sponsorship and must be able to pass a comprehensive background check, including a drug screening.

About the Role

Thermo Fisher Scientific’s PPD® Laboratory Services team advances patient health through scientific expertise, innovative research, and delivery of life‑changing therapies. As a Scientist you will work in a multi‑functional environment supporting drug development, collaborating with cross‑functional teams, and applying state‑of‑the‑art technology to drive quality and accuracy.

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 procedures with minimal supervision to quantitatively measure pharmaceutical and biopharmaceutical compounds in various formulations and biological matrices for stability and analytical testing.
• Complete all laboratory documentation in clear, accurate language according to SOPs and GLPs.
• Independently troubleshoot equipment and instruments; mentor others in troubleshooting when applicable.
• Review results, determine acceptability per SOP acceptance criteria, and communicate project status to the project leader.
• Manage QC responsibilities independently and identify workflow gaps or potential roadblocks.
• Perform QA‑facing tasks with minimal supervisor/QA input, author low‑complexity quality records, and participate in OOS/OOT/Atypical investigations.

Qualifications

• Bachelor’s degree in laboratory sciences such as chemistry, biochemistry, or a related field.
• At least 2 years of relevant experience providing the knowledge, skills, and abilities required for the role.

Knowledge, Skills, and Abilities

• Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines.
• Familiarity with applicable regulatory authorities, compendia, and ICH guidelines.
• Excellent manual dexterity for precise and accurate work.
• Strong written and oral communication skills.
• Exceptional time‑management and project‑management abilities.
• Proven problem‑solving and troubleshooting capabilities.
• Ability to cross‑train on sample preparation techniques with other laboratory groups.
• Collaborative mindset aligned with Thermo Fisher’s 4i Values (Integrity, Intensity, Innovation, Involvement).

Work Environment

• Adherence to all Good Manufacturing Practices (GMP) and safety standards.
• Ability to communicate and understand information with diverse groups.
• Ability to work upright, stationary, and/or standing for typical working hours.
• Ability to lift and move objects up to 25 pounds.
• Potential exposure to hazardous elements, including infectious agents common in healthcare or laboratory settings.
• Ability to use standard office equipment and technology proficiently.
• Capability to perform successfully under pressure while handling multiple projects.