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Gilead

Sr. Associate Scientist, Analytical Operations

For Current Gilead Employees and Contractors:

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

Job Description

Sr. Associate Scientist, Analytical Core Team – Analytical Operations – Foster City, CA

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. 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.

Gilead Sciences is currently seeking a Sr. Associate Scientist to join the Analytical Core Team Group, Analytical Operations department within PDM. The Sr. Associate Scientist is responsible for executing laboratory techniques and validation protocols in support of early phase clinical projects as well as GMP operations. In addition, the group includes a function which supports preparation of regulatory submissions.

Job Responsibilities:

  • Write and execute study plans, validation protocols and reports to support early phase clinical projects.
  • Execute laboratory techniques such as appearance, water content, dissolution, disintegration, Liquid Chromatography, Gas Chromatography, DSC, particle size, XRPD, infrared and UV-Vis spectroscopy
  • Manage direct report(s), provide leadership, mentoring, and training for junior staff.
  • Lead cross-functional projects to ensure e method validation and data review according to test methods, specifications, and protocols to support clinical use.
  • Draft, revise test methods and SOPs.
  • Apply knowledge of current Good Manufacturing Practices (cGMPs) concepts.
  • Participate in meetings, present and interpret data.
  • Support internal and regulatory inspections.
  • Lead laboratory investigations and facilitate timely closure with QA.
  • Knowledge in Lab information System and Part 11 software (e.g. Empower, LES, ELN, SDMS, and LIMS) to ensure data integrity rules are followed and documentation are in compliance.
  • Knowledge in Compliance System (e.g. GTrack, GxP Learn, EDMS and RDMS)
  • Work with Laboratory Information System team on equipment management, participate in user requirements, assessment and validation of 21 CFR Part 11 software and/or customized software plus reviewing supporting documents such as SOPs, User Manuals, Reference and Training Documentation.
  • Work with Regulatory Affairs & Quality Assurance to ensure that all applicable FDA regulations are followed and properly documented.
  • Work with facilities management to ensure compliance with all OSHA regulations, including management of hazardous material.

Education, Experience, and Skills:

  • MS degree with 9+ years’ experience or BS degree with 11+ years’ industry experience
  • Selects appropriate techniques in performing testing and GMP validation
  • Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
  • May make contributions to scientific literature and conferences or regulatory filings.
  • Excellent communication skills (both verbal and technical) and strong interpersonal skills are required.

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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.

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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