Scientist II - GMP, Cell & Gene Therapy

About the role

This is a fully onsite Scientist II position within the Cell & Gene Therapy (CGT) department at our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the U.S. Relocation assistance is not provided; any relocation costs are the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship and able to pass a comprehensive background check, including a drug screening.

Responsibilities

• Train on routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines.
• Perform a variety of routine to complex sample preparation and analysis procedures with minimal supervision to quantitatively measure pharmaceutical and biopharmaceutical compounds in formulations and/or biological matrices for stability and analytical testing.
• Complete all laboratory documentation clearly and accurately according to SOP and GLPs.
• Independently troubleshoot equipment and instruments; mentor others in troubleshooting when applicable.
• Review and comply with results from assignments and make initial determinations on acceptability per SOP acceptance criteria.
• Perform work assignments accurately, timely, and safely; independently manage QC responsibilities.
• Communicate project status to project leader, identify gaps, and anticipate roadblocks in project team workflow.
• Complete QA-facing tasks with minimal supervisor/QA input; author low-complexity quality records and participate in OOS/OOT/Atypical investigation processes.

Requirements

• Bachelor’s degree in lab sciences such as chemistry, biochemistry, or similar.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

Qualifications

• Previous GMP experience strongly preferred.
• Previous experience with siRNA, RNAi, DNAi, viral vectors, cell-based therapeutics, HPLC, q/ddPCR, separation methodologies, and/or impurity analysis strongly preferred.
• Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines.
• Knowledge of applicable regulatory authority, compendia, and ICH guidelines.
• Demonstrated excellent manual dexterity for precise and accurate work.
• Strong written and oral communication skills.
• Exceptional time management and project management skills.
• Proven problem-solving and troubleshooting abilities.
• Ability to cross-train on sample preparation techniques with another laboratory group.
• Thrives in a collaborative work environment and aligns with the 4i Values of Thermo Fisher.

Work Environment

• Able to communicate, receive, and understand information with diverse groups of people.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.