About the Company
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, or increasing laboratory productivity, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through our industry-leading brands.
Job Description
We are seeking a highly motivated and experienced Methods Validation Chemist with a specialized focus on regulatory compliance to join our dynamic team in Pasco, Washington. The successful candidate will be responsible for the development, validation, and transfer of analytical methods in accordance with cGMP, ICH, and other relevant regulatory guidelines. This role requires a strong background in analytical chemistry, meticulous attention to detail, and a thorough understanding of regulatory expectations for method validation in a pharmaceutical or biotechnology environment. You will play a crucial role in ensuring the quality and integrity of our analytical data, directly contributing to product development and regulatory submissions.
Key Responsibilities
- Design, execute, and document method validation studies (e.g., specificity, linearity, accuracy, precision, quantitation limits, detection limits, robustness, stability) for various analytical techniques.
- Develop and revise Standard Operating Procedures (SOPs), validation protocols, reports, and other technical documents in compliance with regulatory standards (e.g., FDA, ICH, USP, EP).
- Perform routine and non-routine analytical testing using instruments such as HPLC, GC, LC-MS, UV-Vis, FTIR, Karl Fischer, and dissolution apparatus.
- Troubleshoot analytical instrumentation and methods, ensuring optimal performance and data quality.
- Collaborate cross-functionally with R&D, Quality Assurance, Manufacturing, and Regulatory Affairs teams.
- Provide technical expertise and guidance on method validation strategies and regulatory requirements.
- Participate in laboratory investigations, out-of-specification (OOS) results, and deviations, identifying root causes and implementing corrective and preventive actions (CAPAs).
- Stay current with industry trends, regulatory changes, and advancements in analytical methodology.
Required Skills
- Bachelor's degree in Chemistry, Analytical Chemistry, Biochemistry, or a related scientific field.
- Minimum of 4 years of experience in method validation within a cGMP/GLP regulated laboratory environment.
- Proficiency with various analytical techniques, including HPLC, GC, UV-Vis, and dissolution testing.
- In-depth understanding of ICH guidelines Q2(R1) and other relevant regulatory requirements for method validation.
- Strong technical writing skills for protocols, reports, and SOPs.
- Excellent problem-solving abilities and attention to detail.
- Ability to work independently and as part of a team in a fast-paced environment.
Preferred Qualifications
- Master's degree or Ph.D. in Chemistry or a related field.
- Experience with LC-MS, GC-MS, or other advanced spectroscopic techniques.
- Knowledge of LIMS (Laboratory Information Management System) and electronic laboratory notebooks (ELN).
- Experience with statistical analysis software for method validation data.
- Previous experience supporting regulatory submissions (e.g., ANDA, NDA, BLA).
Perks & Benefits
- Comprehensive Medical, Dental, and Vision insurance plans
- 401(k) with company match
- Generous Paid Time Off (PTO) and paid holidays
- Life and Disability Insurance
- Employee stock purchase plan
- Tuition reimbursement and professional development opportunities
- On-site fitness center or wellness programs
- Employee assistance program
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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