Scientist II - GMP Laboratory

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 U.S. 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. Our PPD Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought leaders and therapeutic experts.

Responsibilities

As a Scientist 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.

• 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

• 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’)
• Previous GMP Laboratory experience strongly preferred
• Previous experience with HPLC, CE, iCE, or ELISA preferred
• Previous experience with cell culture, mammalian cell culture, flow cytometry, PCR, ELISA or cell-based bioassays preferred
• Previous experience with method troubleshooting, optimization, and/or validation is a plus
• Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines.
• Knowledge of applicable regulatory authority, compendia and ICH guidelines.

Skills

• 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.

• 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.