Associate Scientist, Analytical Outsourcing & Stability (AOS)

Location
Foster City, CA
Posted
Oct 07, 2021
Ref
2544117
Required Education
Bachelors Degree
Position Type
Full time
Associate Scientist, Analytical Outsourcing & Stability (AOS)
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


Associate Scientist, Analytical Outsourcing & Stability (AOS)

Specific Responsibilities
  • Manage stability projects for drug substances and drug products supporting clinical development and commercial commitment.
  • Apply knowledge of cGMP and work with QA to ensure applicable cGMP regulations are followed.
  • Design stability protocols in accordance with ICH guidelines and project needs.
  • Oversees stability testing at contract laboratories to ensure stability is initiated meeting project timeline, samples are analyzed per protocol requirements and results are reported to Gilead in a timely fashion.
  • Review testing data and results to ensure compliance to appropriate test methods, specification, and protocols.
  • Evaluates stability results through data interpretation and statistical trending to help justify recommended storage conditions and retest period/shelf-life.
  • Authorize stability samples in LIMS and issues stability summary reports.
  • Provides stability data to support regulatory filings and response to agency requests.
  • Serves as resource for deviations, investigations, OOT/OOS, and CAPAs for stability related quality events.
  • Write and revise protocols, and SOPs as needed with minimal direction.
  • Capture, measure, and report critical performance and compliance metrics related to stability testing, review, and approval cycle times and investigations.


Knowledge & Skills
  • Critical thinking skills and ability to solve moderately complex problems and good judgement in making recommendations.
  • Excellent interpersonal skills and ability to work effectively with people from a wide range of skill levels and experience.
  • Excellent verbal and written communication skills.
  • Ability to work independently and as part of a team with internal and external partners, self-motivation, adaptability, and a positive attitude.


Required Education & Experience
  • A Bachelor's Degree in Chemistry or Biology with eight (8) years of relevant experience, OR a Master's Degree in Chemistry or Biology with six (6) years of relevant experience.
  • Working knowledge of industry standards and regulatory requirements pertaining to pharmaceutical stability testing.
  • Knowledge and understanding of cGMP, quality control (QC), and regulatory requirements for GMP laboratories in pharmaceutical industry.
  • Hands-on experience with analytical techniques such as UPLC/HPLC, Dissolution, KF titrations, Thermogravimetric DSC/TGA, particle size, disintegration.
  • Knowledge of software such as LIMS, Empower, Trackwise, etc.


Preferred Experience
  • Experience in biologics drug development and analytical/QC aspects is a plus.


If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.yello.co/external/form/24a8oU4jF5UL3CKq7lO_Cg

About Gilead

Gilead Sciences, Inc. is a research-based biopharmaceutical 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.

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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 careers@gilead.com for assistance.

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