Scientist II – Biosafety Testing

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Scientist II

Location: Middleton, Wisconsin

Department: Biosafety

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

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Discover Impactful Work:

As a Scientist II you will work in a multi-functional environment supporting drug development and will collaborate in cross-functional teams. You will accomplish our mission through innovation and partnership, creative problem-solving, and use of state-of-the-art technology.

A Day in the Life:

• 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 compiles 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 anticipate 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.

Education

• Bachelor's degree in lab sciences such as chemistry, biochemistry or similar

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills, Abilities

• Previous experience working with and maintaining cell lines, cell cultures, and performing complex, multi-step assays preferred.
• 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

Work Environment

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