Senior Associate Scientist - Pre-Pivotal Biologics Analytical Operations

Job Description

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.

Job Description

Gilead Sciences (Foster City, CA) is seeking a talented and highly motivated Senior Associate Scientist to join our Pre-Pivotal Biologics Analytical Operations group.

Our collaborative and interdisciplinary development team utilizes state-of-the-art technologies and innovative methodologies to advance medicines into the clinic.

The successful candidate is expected to serve as the analytical lead on PDM (Pharmaceutical Development & Manufacturing) project teams.

S / he will have opportunities for career growth through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment.

Responsibilities :

Develop analytical methods (ELISA and RT-QPCR) to be used for release testing and characterization. Author associated method development reports, test procedures, and relevant method transfer documents.

Troubleshoot method related issues, improve and optimize as needed.

• Organize, prepare, and maintain critical reagents with appropriate system suitability criteria
• Present findings to cross functional internal / external teams.
• Proactively evaluate and implement state of the art technologies to drive innovation in Analytical Development and testing
• Oversee and advise data generation / data integrity and ensure compliance and analytical excellence from internal and outsourced testing at contract organizations.
• Maintain strong relationships with key stakeholder functions and work cross-functionally with colleagues in Research, Clinical Development, and Clinical Supply Management and Strategy Teams by providing technical and strategic input
• Provide technical support to internal and external cGMP manufacturing operations.
• Presents research findings and recommendations to senior staff, prepare research reports and peer-reviewed manuscripts, and contribute to the preparation of INDs, and patent filings

Qualifications :

• M.S. with 4+ years or BS with 6+ years of experience in Analytical Chemistry or related fields of industrial experience in biologics analytical development.
• Experience with analytical method development, validation, and control strategies of biologic products (e.g. process related impurities including host cell protein, host cell DNA, and affinity resin materials).
• Hands on experience with or interest / aptitude to learn HPLC, MS, and Capillary Electrophoresis and other separation methods for protein analysis is a plus
• Familiar with FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product.
• Ability of building strong collaborations with other CMC functions.
• Working knowledge of lab automation, computer validation, data governance, data science, knowledge management and data protection.
• Create Inclusion - knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the way they manage their teams.

Gilead Core Values

• Integrity (Doing What’s Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)

The salary range for this position is : $133,280.00 - $172,480.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.

These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

Benefits include company-sponsored medical, dental, vision, and life insurance plans*.