Thermo Fisher Scientific · 1 day ago
Scientist III (GMP, Biopharmacuetical)
Middleton, WI
Full-time
Onsite
Senior Level
5+ years expThermo Fisher Scientific is a leading company in the biopharmaceutical industry, focused on enabling customers to make the world healthier, cleaner, and safer. As a Scientist III, you will perform complex sample preparation and analysis procedures, coordinate laboratory activities, and lead data evaluation to ensure quality and compliance with regulatory standards.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
No H1B
Responsibilities
Trains on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines
Independently performs and gives guidance on a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and for stability and analytical testing
Completes all laboratory documentation in clear and accurate language according to SOP and GMPs
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. Navigates the OOS/OOT/Atypical investigation process. Leads investigations and Root Cause Analysis and proposes CAPAs
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
Coordinates laboratory activities of other team members in conjunction with the lab supervisor
Assists with the study design & protocol authoring. Leads data evaluation and study close-out
Independently completes QA facing tasks
Authors and leads more complex quality records (eg. quality records which may require more in-depth investigation to identify true root causes, quality records requiring cross-departmental input and/or collation of data etc.)
Qualification
Required
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
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and applicable regulatory authority, compendia and ICH guidelines and ability to interpret and consider SOP and regulatory guidelines during study design activities
Ability to understand and independently apply GMPs to everyday work with regard to documentation and instrument use
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
Ability to independently optimize analytical methods
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
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
Preferred
Prior experience HPLC, CE, or iCE in GMP environment strongly preferred
Prior experience with non-routine laboratory work, including analytical method establishment and analytical method validation strongly preferred
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Daniella Cramp
Senior Vice President and President, Bioproduction Group
Recent News
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