Work Schedule

Environmental Conditions

Job Description

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 withoutsponsorship.Must be able to pass a comprehensive background check, whichincludes a drug screening.

Role Overview:

As a Scientist II, you will train on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatoryguidelines. The Scientist II possesses an understanding of laboratory procedures, and with increased independence over time,can conduct complex analysis. This role performs a variety of routine sample preparation and analysis procedures toquantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/orbiological matrices for stability and analytical testing and is responsible for review and compilation of results anddata comparison against SOP acceptance criteria, methodology, protocol and product specifications.

Role 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.

Key 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).

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

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.

• 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

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

• 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.

Apply today!