Senior Scientist, Quality Control Biologics; Analytical Lifecycle Management

Senior Scientist, Quality Control Biologics (Analytical Lifecycle Management)

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Department
:

Global Quality Control – GQC-Biologics

• Provide strategic leadership and oversight of daily Clinical Biologics QC operations within Analytical Lifecycle Management.
• Manage clinical specification strategies, reference standards and critical reagents programs, analytical method validations and transfers, and the compendial review program.
• Monitor QC test method execution and lead the analytical lifecycle management of clinical biologics drug substances and drug products.
• Develop and implement company-wide long-term quality solutions in collaboration with senior management.
• Motivate and engage individuals; influence processes and outcomes across functions; apply GMP principles in US and international settings.
• Willingness to support future laboratory work and the Commercial QC team as needed.

• 8+ years experience with BS OR 6+ years with MS OR 2+ years PhD in Chemistry, Biochemistry or related field
• Preferred 2+ years of relevant GMP lab experience, including knowledge of analytical testing and familiarity with laboratory instrumentation
• Preferred experience in Biopharmaceutical or Pharmaceutical quality control; stays ahead of shifting industry trends and GMP systems/software (e.g., LIMS, QMS, Empower)
• Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems
• Strong organizational and planning skills; excellent verbal and written communication and collaborative interpersonal skills

• Job Requisition : R0044321
• Full Time/Part Time:
  Full-Time
• Job Level: Manager
• Remote Type:
  Onsite Required