Scientist — Quality Control Biologics- Analytical Method Validation and Transfer
$136k/y-$176k/y
3 days ago
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OnsiteFull-timeSenior
Summary
Gilead Sciences, Inc. is seeking a Scientist — Quality Control Biologics- Analytical Method Validation and Transfer to join their team in the San Francisco Bay Area. The role involves supporting Commercial analytical method validations and transfers, contributing to monitoring QC test method execution, and leading the analytical lifecycle management of Commercial biologics drug substances and drug products.
About the Role
As a Scientist in Quality Control Biologics, you will provide strategic leadership and oversight of daily operations within the Global Quality Control department. Your responsibilities will include supporting the analytical lifecycle management, developing solutions to complex problems, and ensuring compliance with GMP principles and standards. You will also be expected to motivate and engage team members while influencing processes and outcomes across functions.
About You
Required:
- PhD in Chemistry, Biochemistry or related field OR
- Master's Degree in Chemistry, Biochemistry or related field and 4+ years of relevant experience OR
- Bachelor's Degree in Chemistry, Biochemistry or related field and 6+ years of relevant experience OR
- Associate’s Degree in Chemistry, Biochemistry or related field and 8+ years of relevant experience OR
- High School Degree and 10+ years of relevant experience
Preferred:
- Experience authoring validation protocols and reports for commercial or late-stage products.
- Experience developing method transfer plans, including authoring gap assessments, master transfer plans, protocols, and reports.
- Experience interacting with and providing oversight of QC activities at CDMOs and CTLs.
- Experience leading or participating in the development of product specification setting for commercial or late-stage products.
- 1+ year of relevant QC experience in a GMP Lab environment, including knowledge of analytical testing, familiarity with laboratory instrumentation and GMP systems/software (e.g. LIMS, QMS, Empower) for biologics drug substances and drug products.
- Experience in Biopharmaceutical or Pharmaceutical quality control.
Benefits
- Discretionary annual bonus based on performance.
- Discretionary stock-based long-term incentives.
- Paid time off.
- Company-sponsored medical, dental, vision, and life insurance plans.
Gilead Sciences
At Gilead, we set – and achieve – bold ambitions to create a healthier world for all people. From our pioneering virology medicines to our growing impact in oncology, we're delivering innovations once thought impossible in medicine. Our focus goes beyond medicines, and we also strive to remedy health inequities and break down barriers to care. We empower our people to tackle these challenges, and we’re all united in our commitment to help millions of people live healthier lives. Social Media Guidelines: https://www.gilead.com/social-media-guidelines
San Francisco Bay Area