Senior Scientist -- Pre-Pivotal Biologics, Analytical Operations

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 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.

The salary range for this position is: $169,320.00 - $219,120.00. 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*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.
 

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