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, increasing productivity in their labs, improving patient health through diagnostics or the development and manufacture of life-changing therapies, 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, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Job Description
We are seeking a highly motivated and experienced Senior Analytical Scientist with a strong focus on method development to join our innovative team in Riverside, CA. In this critical role, you will be responsible for designing, developing, optimizing, and validating analytical methods for the characterization of various biopharmaceutical products and processes. You will leverage your expertise in a wide range of analytical techniques to support drug discovery, process development, and quality control activities. The ideal candidate will possess a deep understanding of analytical chemistry principles, excellent problem-solving skills, and a proven track record of successful method development and validation in a regulated environment (e.g., GMP/GLP). This position offers a dynamic work environment where you will contribute significantly to the advancement of groundbreaking scientific projects and collaborate with cross-functional teams.
Key Responsibilities
- Design, develop, optimize, and validate robust analytical methods for raw materials, in-process samples, and finished drug products using various techniques (e.g., HPLC, GC, LC-MS, spectroscopy, dissolution).
- Perform complex analytical testing and data interpretation to support formulation development, process characterization, stability studies, and quality control.
- Troubleshoot method performance issues, instrument malfunctions, and sample-related challenges, implementing effective solutions.
- Author and review technical documents, including method development reports, validation protocols and reports, SOPs, and stability protocols.
- Provide scientific mentorship and guidance to junior scientists, fostering a collaborative and high-performing team environment.
- Stay current with industry trends, regulatory guidelines (FDA, ICH), and new analytical technologies.
- Ensure all laboratory activities comply with cGMP/GLP regulations and company quality standards.
- Present findings and communicate project updates to internal and external stakeholders.
Required Skills
- Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with 5+ years of experience, OR Master's with 8+ years, OR Bachelor's with 10+ years in the pharmaceutical/biotechnology industry.
- Extensive hands-on experience in developing and validating analytical methods for small molecules or biologics.
- Proficiency with a variety of analytical techniques including HPLC, UPLC, GC, LC-MS, UV-Vis, FTIR, and dissolution testing.
- Strong understanding of ICH guidelines (Q2(R1)) and regulatory requirements for method validation.
- Demonstrated expertise in data analysis, statistical evaluation, and interpretation of complex analytical results.
- Excellent written and verbal communication skills.
- Ability to work independently and as part of a cross-functional team.
Preferred Qualifications
- Experience with advanced separation techniques (e.g., SFC, CE).
- Proficiency in software for data acquisition and analysis (e.g., Empower, ChemStation, MassHunter).
- Knowledge of QbD (Quality by Design) principles for method development.
- Experience in a GMP-regulated laboratory environment.
- Familiarity with compendial methods (USP, EP, JP).
Perks & Benefits
- Comprehensive medical, dental, and vision insurance.
- 401(k) retirement plan with company match.
- Generous paid time off, including vacation, sick leave, and holidays.
- Life and disability insurance.
- Employee stock purchase plan.
- Tuition reimbursement and professional development opportunities.
- On-site fitness center and 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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