Scientist — Quality Control Biologics; Analytical Lifecycle Management

Scientist — Quality Control Biologics (Analytical Lifecycle Management)

Gilead Sciences, Inc. is a biopharmaceutical company dedicated to preventing and treating life‑threatening diseases, including HIV, viral hepatitis, and cancer. The company operates worldwide and focuses on developing therapies that improve lives.

The Scientist, Analytical Lifecycle Management supports commercial biologics QC by providing strategic leadership and oversight of daily operations.

Responsibilities include:

• Supporting commercial specification strategies and reference standard programs.
• Managing raw materials and critical reagent programs.
• Leading analytical method validations, transfers, and compendial review.
• Monitoring QC test method execution and driving the analytical lifecycle management of commercial biologics drug substances and drug products.

• Experience across a broad set of Quality Control sub‑functions with extensive knowledge of industry best practices and trends.
• In‑depth understanding and application of GMP principles, concepts, practices, and standards in the US and internationally.
• Ability to develop and improve complex concepts, techniques, and standards based on quality principles and theories.
• Develop solutions to complex problems requiring ingenuity, creativity, and innovation.
• Exercise judgment independently and take appropriate action where precedent may not exist.
• Work with senior management to develop and ensure company‑wide long‑term solutions.
• Motivate and engage individuals.
• Influence processes and outcomes across functions.
• Support future laboratory work and the commercial QC team.

• Ph.D. in Chemistry, Biochemistry or related field.
• Master’s Degree in Chemistry, Biochemistry or related field and 4+ years of relevant experience.
• Bachelor’s Degree in Chemistry, Biochemistry or related field and 6+ years of relevant experience.
• Associate’s Degree in Chemistry, Biochemistry or related field and 8+ years of relevant experience.
• High School diploma and 10+ years of relevant experience.

• Experience developing and/or leading reference standard and critical reagent programs for commercial or late‑stage biologics drug substances and products.
• Experience authoring validation protocols and reports for commercial or late‑stage products.
• 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 environment, including knowledge of analytical testing, laboratory instrumentation, and GMP systems/software (e.g., LIMS, QMS, Empower).
• Experience in biopharmaceutical or pharmaceutical quality control, keeping ahead of industry trends.
• Ability to think critically and creatively, working independently to allocate resources for problem resolution.
• Strong organizational and planning skills.
• Excellent verbal and written communication skills and collaborative interpersonal skills.

Salary range: $ – $. The actual compensation depends on experience, qualifications, and location. The position may also qualify for discretionary annual bonuses, stock‑based long‑term incentives, paid time off, and a benefits package that includes company‑sponsored medical, dental, vision, and life insurance plans.

For additional benefits information, visit:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity and expression, veteran status, or other protected characteristics.

Applicants who require accommodation in the job application process may contact Appli for assistance.

Remote Type: Onsite Required
Job Requisition : R0044679