Scientist, Analytical Operations
About The Position
The Scientist, Analytical Ops provides analytical and scientific leadership to support the development, characterization, and advancement of drug candidates. Working across analytical disciplines and functions, this role plans and executes laboratory activities, develops fit-for-purpose analytical methods, and interprets scientific data to address complex development challenges. The Scientist applies strong laboratory expertise and scientific judgment to strengthen product understanding, inform impurity control strategies, and support timely project decisions. This work contributes to analytical development activities needed to advance clinical programs and key development deliverables. The position is based in Foster City, California, and is fully onsite. The role leads critical components of cross-functional projects and contributes to departmental initiatives or technology programs. It collaborates across functions to solve scientific and technical problems and provide analytical recommendations that support project decisions.
Requirements
- Bachelor’s degree and 6 or more years of relevant experience, or a master’s degree and 4 or more years of relevant experience, or a PhD or PharmD and 0 or more years of relevant experience.
- Strong hands-on experience in analytical method development, optimization, and troubleshooting.
- Strong scientific judgment and data interpretation skills.
- Ability to independently define analytical approaches and address complex laboratory and development challenges.
- Ability to collaborate effectively across analytical disciplines, functions, and organizational levels.
- Ability to begin contributing to hands-on laboratory activities with limited onboarding.
Nice To Haves
- Degree in chemistry, biology, or a related scientific discipline.
- Pharmaceutical or biotechnology industry experience.
- Experience with liquid chromatography, gas chromatography, Karl Fischer analysis, or related analytical techniques.
- Experience conducting stability, stress, and degradation studies.
- Knowledge of impurity assessment and control, including process-related impurities, mutagenic and potentially mutagenic impurities, and nitrosamines.
- Experience applying Quality by Design, Design of Experiments, or Method Operable Design Region principles to analytical method development.
- Experience supporting development and characterization of solid oral, parenteral, or combination products.
Responsibilities
- Provide technical leadership in developing and optimizing analytical methods for complex or challenging assignments.
- Define analytical strategies, approaches, and techniques that address technical needs and advance project objectives.
- Design, plan, and execute laboratory experiments to resolve analytical and development challenges.
- Maintain a hands-on laboratory presence; troubleshoot experiments, interpret data, and resolve technical issues using scientific judgment.
- Anticipate analytical needs across drug development and address evolving project requirements.
- Plan, prioritize, and execute analytical activities for raw materials, intermediates, drug substances, and drug products in line with project objectives and timelines.
- Design and perform physicochemical analyses, including liquid chromatography, gas chromatography, and Karl Fischer analysis.
- Conduct fit-for-purpose development studies, including stress, degradation, and accelerated stability studies, to strengthen product understanding and inform development strategies.
- Develop and apply sensitive analytical methods to assess process-related impurities, mutagenic and potentially mutagenic impurities, and nitrosamines where applicable.
- Contribute to scientifically sound impurity control strategies based on analytical findings and development needs.
- Provide analytical expertise for development and characterization of formulations, product intermediates, and dosage forms, including solid oral, parenteral, and combination products.
- Apply Quality by Design principles, including Design of Experiments and Method Operable Design Region approaches, to develop robust analytical methods and support method understanding consistent with ICH Q14 principles.
- Keep current with scientific literature, emerging analytical technologies, and relevant regulatory expectations, and apply this knowledge to development programs.
- Lead critical components of cross-functional projects and contribute to departmental initiatives or technology programs.
- Collaborate across functions to solve complex scientific and technical problems and provide analytical recommendations supporting project decisions.
Benefits
- Discretionary annual bonus eligibility.
- Discretionary stock-based long-term incentives; eligibility may vary by role.
- Paid time off.
- Company-sponsored medical insurance.
- Company-sponsored dental insurance.
- Company-sponsored vision insurance.
- Company-sponsored life insurance.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
