Sr. Research Scientist I, Analytical Ops
Sr. Research Scientist I, Analytical Ops
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Specific Responsibilities & Skills for the Position:
- A strong leader in Analytical Operations within Product Development & Manufacturing, responsible for analytical CMC strategies and drug product development from phase 1 to commercialization. Accountable for release, stability, investigations, and change control for clinical API, drug product intermediate, and drug product
- Oversees contract testing laboratory (CTL) sites for method development, stability testing and method validation/transfer, and escalates issues to senior management as necessary to ensure timely resolution.
- Participate and provides leadership in method development and optimization, method transfer, validation, shipping studies, bulk hold studies, in-use testing during product development stage.
- Provide technical and regulatory support to the drug substance and drug product development, including form selection, process route development, formulation development.
- Accountable to summarize studies, generate, review and approve necessary reports to provide scientifically sound and data-based support of product development.
- Together with cross-functional partners, critically reviews changes and impacts to product and process, and regulatory commitment and manages associated change control documentation.
- 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 necessary support during regulatory inspections of Gilead or at contract partner sites for Gilead API and drug product.
- Partners with QA, Regulatory Affair, CMC Regulatory Science, Stability and GMP groups, and commercial teams to support the IND, IMPD, marketing applications, and stability studies, as needed.
- Provides leadership and drives operational excellence in Analytical Operations and at contract partner sites.
- 3+ years of industry experience and Ph.D. in Chemistry or MS with extensive industry experience
- Knowledge in analytical chemistry and experience in development and quality control in a highly regulated environment
- Excellent written and verbal communications skills required
- Prior people management experience strongly preferred
- Strong desire to work in multi-disciplinary teams, learn new skills and proactively solve problems
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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 firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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 Current Gilead Employees and Contractors:
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