Senior Scientist Pre-Pivotal Biologics, Analytical Operations

United States - California - Foster City
Process/Product Development & Operations
Regular

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 is seeking a talented and highly motivated Senior 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 CMC 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.

This role will sit in our Foster City, CA headquarters.

Responsibilities:

• Lead CMC Analytical sub-team (as ASTL) to identify molecule CQAs, design/justify/execute end-to-end control strategies, support CMC process development, issue CoTs, seek Specification endorsement, and author relevant regulatory filings (Phase I/II IND/IMPD) for biologic drug substance and drug product.
• Lead analytical characterization activities for pre-pivotal (Phase I/II) biologic molecules.
• Develop and execute analytical methods (using HPLC, CE, iCIEF, LC-MS, etc.) to be used for molecule characterization and/or release testing. Author associated method development reports, test procedures, qualification protocols and reports.
• Oversee and advise data generation/data integrity and ensure compliance and analytical excellence from internal and outsourced testing at contract organizations.
• Proactively evaluate and implement state of the art technologies to drive innovation in Analytical Development and testing.
• Maintain strong relationships with key stakeholder functions and work cross-functionally with colleagues in Research, Clinical Development, and Clinical Supply Management and Program Strategy Teams by providing technical and strategic input.
• Provide technical support to internal and external cGMP manufacturing operations.
• Present research findings and recommendations to senior staff, prepare research reports and peer-reviewed manuscripts, and contribute to the preparation of INDs and patent filings.

Basic Qualifications:

• Bachelor's Degree and Eight Years’ Experience
• OR Masters' Degree and Six Years’ Experience
• OR Ph.D.

Preferred Qualifications:

• Ph.D. in Analytical Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Science, or related fields with a minimum of 2+ years of Biologics CMC industrial experience, OR M.S. with a minimum of 6+ years, OR B.S. with a minimum of 8+ years industrial experience in Biologics CMC.
• Previous experience as Biologics CMC Analytical Lead is required.
• Extensive hands-on experience on Biologics (especially mAbs) CMC Analytical Development/Operations and IND/IMPD Submissions.
• Strong Understanding of FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug…