Sr Research Scientist I, Analytical Ops

Location
Foster City, CA, United States
Posted
Jul 19, 2021
Ref
2232238
Required Education
Bachelors Degree
Position Type
Full time
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. Gilead's 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 company's five core values. That's 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

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Specific Responsibilities & Skills for the Position:
  • Partner with Process Chemistry, QA and other groups within Analytical Operations.
  • Leading teams developing analytical specifications and methods and supporting pre-clinical and early clinical small molecule process development and manufacturing.
  • Provide technical and regulatory support to drug substance development, including impurity control strategies and process route development.
  • Accountable to summarize studies, generate, review and approve necessary reports to provide scientifically sound and data-based support of product development.
  • Facilitate method transfer to other Gilead sites and CTLs/CMOs as guided by project requirements.
  • Provide the highest quality analytical support, meet ambitious timelines and ensure compliance to SOPs, protocols, cGMPs and safety regulations
  • Support quality investigations and resolution through collaboration with manufacturing and quality to design meaningful hypothesis testing plans
  • Apply relevant regulatory guidance (USP, ICH, CFR) in daily work and work planning


Essential Education & Skills:
  • 3+ years of industry experience and Ph.D. in Chemistry or BS/MS with extensive industry experience
  • A strong analytical chemist who leads with data and understands the requirements for process development and GMP manufacturing.
  • Familiarity with physical and chemical characterization of drug substances and drug substance intermediates.
  • Knowledge in analytical chemistry and experience in development and quality control in a highly regulated environment
  • Excellent written and verbal communications skills required
  • Comfort working in multi-disciplinary teams, learning new skills and proactively solving problems


Preferred Skills:
  • Experience in writing and gaining approval for GMP investigations, investigation plans and quality investigations/records is desired
  • Prior people management experience viewed positively
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 contact careers@gilead.com for assistance.

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

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

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