About the Company
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon – we offer an unmatched combination of innovative technologies, purchasing convenience and pharmaceutical services.
Job Description
We are seeking a highly motivated and detail-oriented Methods Validation Chemist with a specialized focus on regulatory compliance to join our dynamic team in Milwaukee, WI. In this critical role, you will be responsible for designing, executing, and documenting method validation studies for various analytical test methods used in the quality control of pharmaceutical and biotechnology products. Your expertise will ensure that our analytical methods meet stringent regulatory requirements (e.g., FDA, ICH, USP) and uphold the highest standards of data integrity and product quality. This position requires a strong understanding of analytical chemistry, method validation principles, and current Good Manufacturing Practices (cGMP).
Key Responsibilities
- Develop and execute comprehensive method validation protocols and reports (e.g., specificity, linearity, accuracy, precision, detection limit, quantitation limit, robustness) for various analytical techniques (HPLC, GC, spectroscopy, dissolution, etc.).
- Perform complex chemical analyses and data interpretation to support method validation activities, ensuring compliance with internal SOPs and external regulatory guidelines.
- Collaborate with R&D, Quality Control, and Regulatory Affairs teams to define validation strategies and troubleshoot analytical challenges.
- Maintain accurate and detailed records of all validation experiments, raw data, and results in accordance with cGMP documentation practices.
- Contribute to the investigation of out-of-specification (OOS) and out-of-trend (OOT) results, providing scientific insight and technical support.
- Author and revise Standard Operating Procedures (SOPs) related to analytical methods and validation processes.
- Stay current with industry trends, regulatory changes, and advancements in analytical methodology and validation best practices.
- Participate in regulatory audits and inspections as a subject matter expert for method validation.
- Train junior chemists and laboratory personnel on validated methods and best practices.
Required Skills
- Bachelor's degree in Chemistry, Analytical Chemistry, Biochemistry, or a related scientific field.
- 3+ years of experience in an analytical chemistry laboratory, preferably in a pharmaceutical, biotechnology, or highly regulated industry.
- Proven experience in developing and validating analytical methods for release and stability testing.
- Strong understanding of ICH guidelines (Q2(R1)) and USP chapters related to method validation.
- Proficiency with various analytical instrumentation (e.g., HPLC, GC, UV-Vis, FTIR, AA/ICP-OES/MS).
- Excellent technical writing and communication skills for protocol, report, and SOP generation.
- Demonstrated ability to work independently and as part of a team in a fast-paced cGMP environment.
Preferred Qualifications
- Master's degree or Ph.D. in a relevant scientific discipline.
- Experience with LIMS and electronic data management systems.
- Familiarity with statistical software for data analysis (e.g., JMP, Minitab).
- Knowledge of biologics testing and associated validation challenges.
Perks & Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance plans.
- 401(k) retirement plan with company match.
- Generous paid time off and holiday schedule.
- Tuition reimbursement and professional development opportunities.
- Employee assistance program and wellness initiatives.
- On-site fitness center and cafeteria.
- Dynamic and collaborative work environment with opportunities for career growth.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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