Gilead Sciences, Inc.
Senior Scientist, Quality Control Biologics (Analytical Lifecycle Management)
Gilead Sciences, Inc., Foster City, California, United States, 94420
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
Responsibilities
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.
Qualifications
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 ID: R0044321
Full Time/Part Time: Full-Time
Job Level: Manager
Remote Type: Onsite Required
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Department :
Global Quality Control – GQC-Biologics
Responsibilities
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.
Qualifications
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 ID: R0044321
Full Time/Part Time: Full-Time
Job Level: Manager
Remote Type: Onsite Required
#J-18808-Ljbffr