Scientist II - Cell Lab, GMP

About the role

This is a fully onsite role based at our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship.

Responsibilities

• Trains on routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines.
• Performs a variety of routine to complex sample preparation and analysis procedures with minimal supervision/guidance to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing.
• Completes all laboratory documentation in clear and accurate language and according to SOP and GLPs.
• Independently troubleshoots equipment & instruments.
• Mentors' others in troubleshooting when applicable.
• Reviews and complies results from assignments and makes initial determination on acceptability per SOP acceptance criteria.
• Performs work assignments accurately, and in a timely and safe manner.
• Independently manages QC responsibilities.
• Communicates' project status to project leader and helps to identify gaps and anticipates roadblocks in project team workflow.
• Completes QA facing tasks with minimal supervisor/QA input.
• Authors low complexity quality records and participates in the OOS/OOT/Atypical investigation process.

Requirements

• Education: Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• Experience: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
• Knowledge, Skills, Abilities: Previous hands-on experience with molecular or cell-based laboratory techniques, including mammalian cell culture, flow cytometry, PCR/qPCR, ELISA, or cell-based bioassays, is strongly preferred. Experience supporting analytical method development, troubleshooting, optimization, transfer, or validation in a regulated laboratory environment is preferred.
• Other: Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines; Knowledge of applicable regulatory authority, compendia and ICH guidelines; Demonstrates excellent manual dexterity skills, allowing for precise and accurate work; Exhibits strong written and oral communication skills, facilitating effective communication within the team and with stakeholders; Displays exceptional time management and project management skills, ensuring efficient completion of tasks; Proven problem-solving and troubleshooting abilities, enabling the identification and resolution of issues; Capable of cross-training on sample preparation techniques with another laboratory group, enhancing versatility and collaboration; Thrives in a collaborative work environment, actively contributing to a cohesive and productive team to demonstrate behaviors which align to the 4i Values of Thermo Fisher.

Qualifications

Must be able to pass a comprehensive background check, which includes a drug screening.

Skills

• Previous hands-on experience with molecular or cell-based laboratory techniques, including mammalian cell culture, flow cytometry, PCR/qPCR, ELISA, or cell-based bioassays, is strongly preferred.
• Experience supporting analytical method development, troubleshooting, optimization, transfer, or validation in a regulated laboratory environment is preferred.
• Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines.
• Knowledge of applicable regulatory authority, compendia and ICH guidelines.
• Excellent manual dexterity skills, allowing for precise and accurate work.
• Strong written and oral communication skills, facilitating effective communication within the team and with stakeholders.
• Exceptional time management and project management skills, ensuring efficient completion of tasks.
• Proven problem-solving and troubleshooting abilities, enabling the identification and resolution of issues.
• Capable of cross-training on sample preparation techniques with another laboratory group, enhancing versatility and collaboration.
• Thrives in a collaborative work environment, actively contributing to a cohesive and productive team to demonstrate behaviors which align to the 4i Values of Thermo Fisher.

Benefits

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Pay

Commensurate with experience.

Schedule

First Shift (Days)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Will work with hazardous/toxic materials