Scientist, Analytical Operations

About the Role

The Scientist, Analytical Ops provides analytical and scientific leadership to support the development, characterization, and advancement of drug candidates. 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 the analytical development activities needed to advance clinical programs and key development deliverables. This position is based in Foster City, CA and is fully onsite.

Key Responsibilities

• Provide technical leadership in the development and optimization of 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 complex analytical and development challenges.
• Maintain a strong hands-on laboratory presence and apply scientific judgment to troubleshoot experiments, interpret data, and resolve technical issues.
• Anticipate analytical needs across the drug development process and proactively address evolving project requirements.
• Plan, prioritize, and execute analytical activities for raw materials, intermediates, drug substances, and drug products in alignment with project objectives and development timelines.
• Design and perform physicochemical analyses, including liquid chromatography, gas chromatography, and Karl Fischer analysis.
• Conduct fit-for-purpose development studies, including stress and degradation studies and accelerated stability approaches, 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 to support the 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.
• Maintain current knowledge of 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 that support project decisions.

Qualifications

• Bachelor’s Degree and 6+ years of relevant experience OR Master’s Degree and 4+ years of relevant experience OR PhD or PharmD and 0+ years of relevant experience.
• Degree in chemistry, biology, or a related scientific discipline.
• Pharmaceutical or biotechnology industry experience.
• Strong hands-on experience in analytical method development, optimization, and troubleshooting.
• 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 the development and characterization of solid oral, parenteral, or combination products.
• Ability to independently define analytical approaches and address complex laboratory and development challenges.
• Strong scientific judgment and data interpretation skills.
• Ability to collaborate effectively across analytical disciplines, functions, and organizational levels.
• Ability to begin contributing to hands-on laboratory activities with limited onboarding.

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.