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Gilead

Research Scientist (Compendial Program Owner, Analytical Outsourcing & Stability)

For Current Gilead Employees and Contractors:

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

Job Description

Responsibilities include, but are not limited to, the following:

  • Serve as a business process owner for the compendial review program to review, evaluate, and implement compendial changes which may result in changes to procedures, processes, or systems used by Gilead Sciences
  • Lead a compendial review committee in PDM organization across different sites to drive global process harmonization, site commitment, impact assessment alignment, and program implementation
  • Communicate and coordinate with each site to interpret compendial changes, assess business impact, drive for appropriate actions, and escalate to management as needed
  • Work as a subject matter expert to assess compendial changes to determine the impact to internal procedures, processes, or systems at the site
  • Work with the owners of impacted documents/process to ensure consensus of assessment outcomes and implementation plans
  • Support technology development to drive effective assessment process
  • Create work instructions or business enabling documents to increase process efficiency and compliance
  • Identify training contents and create training materials for each role involved in compendial review program
  • Create, revise, review, and approve quality records (i.e. CAPAs, change managements, etc.) and procedures (i.e., SOPs, WIs, BEDs, etc.)
  • Works with QA and RA to ensure all applicable cGMP and FDA regulations are followed and properly documented
  • Contribute to global analytical and QC strategy

The ideal candidate would possess:

  • Strong working knowledge of cGMPs, pharmacopeias, and regulatory requirements for GMP laboratories in pharmaceutical industry
  • Thorough understanding of pharmacopeias and supplements such as USP-NF, Ph. Eur., JP, etc.
  • Extensive experience with compendial methods such as LC, GC, Dissolution, Thermogravimetric DSC/TGA, KF titrations, particle size, FTIR, etc.
  • Critical/Creative thinking skills and ability to solve complex issues where analysis required an in-depth assessment of various factors and good judgement in making routine recommendations
  • Demonstrated ability to assess risk in day-to-day operations and make appropriate decisions
  • Strong interpersonal skills and ability to work effectively with people
  • Experience of interacting with people from a wide range of skill levels and experience
  • Excellent verbal and written communication skills
  • Demonstrated ability to work independently with strong organizational and planning skills

Typical Education and Experience:

  • B.S or B.A degree in Chemistry related field with 12+ years of relevant experience in an analytical GMP regulated environment
  • M.S. degree in Chemistry or Biology with 10+ years of relevant experience in an analytical GMP regulated environment
  • Prior experience managing compendial review program or other projects is preferred
  • Biopharmaceutical or Pharmaceutical experience is a plus


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.

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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.


For Current Gilead Employees and Contractors:

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

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