Senior Scientist, Analytical Development
About The Position
As a Senior Scientist, Analytical Development, you’ll play a key role in advancing innovative biologic therapies from late-stage research through early clinical development, helping bring potential new medicines closer to patients. In this highly collaborative role, you’ll lead analytical activities focused on potency and biological activity, including developing and optimizing bioassay methods, supporting comparability studies, and guiding internal and outsourced testing. Working closely with scientists and cross-functional partners across Research, Clinical Development, Clinical Supply Management, and Program Strategy, you’ll solve complex scientific challenges and provide technical and strategic insight to support important development decisions. This is an opportunity to apply your expertise, influence analytical strategy, and contribute to a team united by a shared purpose: improving lives through transformative medicines. This position is based in Foster City, CA, and requires onsite work five days per week.
Requirements
- Bachelor’s degree and 8+ years of relevant experience OR Master’s degree and 6+ years of relevant experience OR PhD and 0+ years of relevant experience
Nice To Haves
- Biologics-relevant analytical development experience in the biotechnology or pharmaceutical industry.
- Experience supporting Chemistry, Manufacturing, and Controls (CMC) activities and Phase I investigational new drug applications for biologic products, including IND support or authoring.
- Strong experience developing, validating, and implementing analytical methods and control strategies for biologic products, including potency methods using ELISA and bioassays.
- Hands-on laboratory experience with immunoassays, cell-based assays, and Biacore.
- Experience with process-related impurity methods, including host-cell protein, host-cell DNA, and affinity-resin materials.
- Experience supporting analytical comparability studies for biologic products from late-stage research through Phase I and Phase II development.
- Experience overseeing analytical work performed internally and by contract organizations, including data generation, data integrity, compliance, and analytical excellence.
- Working knowledge of current Good Manufacturing Practice (cGMP) requirements and applicable U.S. Food and Drug Administration (FDA) and International Council for Harmonisation (ICH) guidance concerning registration, quality, and compliance for biologic drug substance and drug product.
- Working knowledge of laboratory automation, computer system validation, data governance, data science, knowledge management, and data protection.
- Strong collaboration and communication skills, with the ability to present scientific findings and provide technical and strategic input to cross-functional internal and external teams.
- Demonstrated curiosity, intellectual humility, and a collaborative approach to scientific problem-solving.
- Ability to work independently with limited guidance and contribute effectively in a fast-paced team environment.
- Experience mentoring or providing technical guidance to less experienced colleagues.
Responsibilities
- Lead analytical activities for pre-pivotal Phase I and Phase II biologic molecules, including comparability studies.
- Design, develop, and execute bioassay potency methods that reflect the mechanisms of action of biologic therapies.
- Troubleshoot, improve, and optimize analytical methods, including ELISA- and qPCR-based methods.
- Organize, prepare, and maintain critical reagents with appropriate system suitability criteria.
- Author method development reports, test procedures, and relevant method transfer documents.
- Oversee and advise on data generation and data integrity for internal and outsourced testing, ensuring compliance and analytical excellence at contract organizations.
- Build and maintain strong relationships with key stakeholders and provide technical and strategic input across Research, Clinical Development, Clinical Supply Management, and Program Strategy.
- Provide technical support for internal and external current Good Manufacturing Practice (cGMP) manufacturing operations.
- Present scientific findings and recommendations to senior staff and cross-functional internal and external teams.
- Prepare research reports and peer-reviewed manuscripts and author or contribute to investigational new drug applications and patent filings.
- Mentor and provide technical guidance to less experienced colleagues.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
