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Associate Director, Analytical Outsourcing and Stability, Commercial Products

Gilead Sciences, Inc.

Foster City, CA
Job Code:
Gilead Sciences, Inc.
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Job Details

Associate Director, Analytical Outsourcing and Stability, Commercial Products
Gilead Sciences, Inc

Job Description

With the commitment and drive you bring to the Pharmaceutical Development & Manufacturing (PDM) workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining PDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases

Specific Responsibilities for the Position:
A strong leader in Analytical Operations within Product Development & Manufacturing, responsible for analytical CMC strategies and lifecycle management of marketed drug products
Oversees global QC testing at commercial manufacturing and contract testing laboratory sites and escalates issues to senior management as necessary to ensure timely resolution
Ensures commercial stability studies are initiated timely to fulfill regulatory commitment and process validation/qualification requirements
Provides leadership in method optimization, method transfer, supplemental validation, shipping studies, bulk hold studies, in-use testing for post approval commercial product support
Together with cross-functional partners, critically reviews changes and impacts to product and process, and regulatory commitment and manages associated change control documentation
Supports Gilead's marketing partners in their ROW submissions, quality control, and investigation needs
Provides necessary support during regulatory inspections of Gilead or at contract partner sites for Gilead API and drug product
Partners with QA and development teams to support the selection and establishment of new contract partners, including performing technical audit, on-site data review, on-site troubleshooting of method implementation challenges, and necessary submission CMC documents
Provides technical leadership in handling customer complaint samples and investigation of potential counterfeiting samples
Documentation responsibilities include annual product quality reviews for APIs and drug products, annual reports of existing submissions, Commercial Product Contractor Manuals, method and study protocols and reports, sNDA CMC documentations, and response to deficiencies to support regulatory filings in ROW countries
Serves as a key member of the Gilead team in the contract lab qualification process
Provides leadership and drives operational excellence in Analytical Operations and at contract partner sites

Knowledge, Experience & Skills
12+ years of experience and PhD in Chemistry
BS or MS degree with extensive industry experience


For jobs in the United States:
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 contactcareers@gilead.comfor assistance

For more information about equal employment opportunity protections, please view the?EEO is the Law'poster


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

For jobs in France:
Conformément à la Loi « Informatique et Libertés » (06/01/78), nous vous informons du fait que les données personnelles renseignées pourront faire l'objet d'un traitement informatique par Gilead et pourront être transmises aux Organismes Sociaux. Par ailleurs, vous disposez d'un droit d'accès, de rectification et de suppression des données vous concernant. Vous pouvez exercer ce droit en

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job

For full application instructions and position description, visit

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