Scientist — Quality Control Biologics; Analytical Lifecycle Management

Overview

Scientist — Quality Control Biologics
- Reference Standard Lead

Gilead Sciences, Inc. is a biopharmaceutical company pursuing breakthroughs to create a healthier world. The company operates in more than 35 countries with headquarters in Foster City, California. We are committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. We seek a candidate to contribute to Commercial Biologics QC with strategic leadership and oversight of daily operations related to reference standards, raw materials, and critical reagents programs, as well as specification strategies.

The role involves monitoring QC test method execution and leading the analytical lifecycle management of commercial biologics drug substances and drug products.

Department
:
Global Quality Control – GQC-Biologics

• The Scientist, Analytical Lifecycle Management supports strategic leadership and oversight for Commercial Biologics QC, including reference standards, raw materials, critical reagents programs, and specification strategies.
• Lead analytical lifecycle management of commercial biologics drug substances and drug products and monitor QC test method execution.

Basic Qualifications:

• PhD in Chemistry, Biochemistry or related field OR
• Master's Degree in Chemistry, Biochemistry or related field with 4+ years of relevant experience OR
• Bachelor's Degree in Chemistry, Biochemistry or related field with 6+ years of relevant experience OR
• Associate’s Degree in Chemistry, Biochemistry or related field with 8+ years of relevant experience OR
• High School Degree with 10+ years of relevant experience

Preferred Qualifications:

• Experience developing and/or leading reference standard and critical reagent programs for commercial or late-stage biologics drug substances and drug products
• Experience authoring reference standard and critical reagent qualification and stability protocols
• 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 laboratory, including knowledge of analytical testing and 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
• Ability to think critically and creatively and work independently to determine appropriate resources for resolution of problems
• Strong organizational and planning skills
• Excellent verbal and written communication and collaborative interpersonal skills

Salary range: $ – $. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This role may be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package, including medical, dental, vision, and life insurance plans. See  for details. Eligible employees may participate in benefit plans subject to plan terms.

Gilead is an equal opportunity employer. We provide an inclusive work environment and do not discriminate on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity or expression, veteran status, or other legally protected characteristics. Reasonable accommodations are available during the application process via Appli For more information about equal employment opportunity protections, view the Know Your Rights poster.

Please apply via the Internal Career Opportunities portal in Workday.

Job Requisition : R0044386

Full Time/Part Time:
Full-Time

Job Level: Manager

Remote Type:
Onsite Required

Note:

This description consolidates the essential elements of the role and removes boilerplate and site-specific notices to present a focused job profile.