Senior Scientist, Analytical Development

Gilead Sciences•Foster City, CA

17h•Onsite

About The Position

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. 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
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.
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.