Job Abstract

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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 research 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: 

• Lead analytical characterization activities for pre-pivotal (Phase I/II) biologic molecules.  Identify molecule critical quality attributes, propose and justify analytical control strategies, author relevant regulatory filings for biologic drug substance and drug product.
• Develop analytical methods to be used for molecule characterization and/or release testing.  Author associated method development reports, test procedures, validation 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 and automation 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

Qualifications: 

• Ph.D. with 2+ years OR M.S. with 8+ years OR 10+ Years with BS experience in Analytical Chemistry or related fields of industrial experience in biologics analytical development.
• Demonstrated ability for taking initiative, creativity, and innovation in problem solving.
• Experience with analytical method development, validation, lab automation and control strategies of biologic products (e.g. UPLC/HPLC, CE-SDS, iCIEF, LC-MS/MS, intact mass, PCR, etc).
• Familiar with FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product. 
• Hands-on in lab execution and has experience of training junior members
• Working knowledge of 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) 

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.

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 ApplicantAccommodations@gilead.com for assistance.
 

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

Please log onto your Internal Career Site to apply for this job.