Gilead Sciences · 1 week ago
Scientist — Quality Control Biologics- Analytical Method Validation and Transfer
San Francisco Bay Area
Full-time
Onsite
Mid, Senior Level
$136K/yr - $176K/yr
4+ years expGilead Sciences is a biopharmaceutical company dedicated to creating a healthier world by developing innovative therapies for life-threatening diseases. The Scientist in Quality Control Biologics will be responsible for supporting analytical method validations and transfers, overseeing daily operations, and contributing to the management of quality control processes for commercial biologics. This role requires collaboration with senior management and a strong understanding of GMP principles.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
The Scientist, Analytical Lifecycle Management is vital for the success of Commercial Biologics QC, providing support for strategic leadership and oversight of daily operations
Responsibilities include supporting Commercial analytical method validations and transfers, compendial review program, and specification setting strategies
The role will contribute to monitoring QC test method execution and leading the analytical lifecycle management of Commercial biologics drug substances and drug products
Experience over 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
Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories
Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness
Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist
Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions
Demonstrated the ability to motivate and engage individuals
Demonstrated the ability to influence process and outcomes across functions
Willing to support future laboratory work
Willing to support Commercial QC team
Qualification
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
Experience over 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
Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories
Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness
Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist
Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions
Demonstrated the ability to motivate and engage individuals
Demonstrated the ability to influence process and outcomes across functions
Willing to support future laboratory work
Willing to support Commercial QC team
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. Stays ahead of shifting trends in industry
Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems
Strong organizational and planning skills
Shows excellent verbal and written communication skills and collaborative interpersonal skills
Benefits
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2026-01-09
2026-01-08
2026-01-07
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