Senior Scientist -- Pre-Pivotal Biologics, Analytical Operations

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 Specfication 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.

• 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.

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 product.

• Experience with analytical method development, validation, and control strategies of biologic products

• Strong communication skills- written, oral, etc.

• Demonstrated ability of building strong collaborations with other CMC functions.

• Familiar with lab automation, data science and knowledge management is a plus.

• Create Inclusion - knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the way they manage their teams.

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.