Research Scientist, Analytical Operations (Quality Control)

Research Scientist, Analytical Operations (Quality Control)
United States - California - Oceanside

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


Research Scientist, Analytical Operations (Quality Control)

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 ongoing 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.

Job Responsibilities

• Serves as SME for chemical/biochemical method validation. Leads development of stage-appropriate validation strategy from Phase 1 clinical development through commercial manufacturing.
  
• Plans, designs, and manages method validation activities in Gilead QC and at contract laboratories.
  
• Coordinates GMP testing in Gilead QC laboratory and leads CAPA activities as necessary.
  
• Oversees review of analytical data from Gilead QC and contract laboratories.
  
• Manages multiple projects; working closely with internal customers, CMOs, and external vendors/contractors to ensure analytical deliverables are met per the project timelines.
  
• Utilizes organizational and planning skills to understand resource capabilities. Negotiates timelines and deliverables based on priorities and resource availability.
  
• Provides high-quality analytical support while meeting aggressive timelines and ensuring compliance to SOPs, protocols, cGMPs, and safety regulations.
  
• Manages 2-3 direct reports with responsibilities in method validation, GMP testing, and process development testing.
  
• Contributes to project teams by communicating strategies and providing timely progress reports.
  
• Supports local and global regulatory filings by authoring and/or reviewing relevant analytical sections.
  
• Participates in or leads cross-functional project teams.
  
• Thinks critically and creatively and proactively identifies improvement opportunities.
  

Essential Education, Experience & Skills

• Ph.D. with 4+ years of relevant experience, or MS with 6+ years of relevant experience, or BS with 8+ years of relevant experience.
  
• Extensive experience in a GMP-regulated laboratory with in-depth knowledge of QC principles, concepts, and industry practices is essential.
  
• Hands-on experience leading product-specific method validation and compendial method verification is required.
  
• Excellent communication and leadership skills are required.
  
• People management experience required.
  
• Keen understanding of international quality control systems regulations to adopt best-in-class systems/processes and drive continuous improvement initiatives.
  
• Preference given to candidates with technical experience in methods used for biologics and parenteral drugs.
  

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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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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