Gilead Sciences · 1 day ago
Director, Quality Control Microbiology- Biologics/Small Molecules
San Francisco Bay Area
Full-time
Onsite
Director/Executive
$210K/yr - $272K/yr
8+ years expGilead Sciences is dedicated to creating a healthier world by tackling significant health challenges. The QC Microbiology Director will provide strategic leadership for Clinical and Commercial Biologics and Small Molecule Quality Control, overseeing microbiological operations and leading the QC team to ensure regulatory compliance and project completion.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Lead the development and implementation of end-to-end Quality Control (QC) microbiological strategies for Gilead’s biologics and small molecules products, including setting up specifications for e.g. cell banks, product, raw materials, environmental monitoring/facilities, etc. Ensure that these strategies are effectively applied across all stages of the product clinical to commercial lifecycle
Lead and Develop Teams. Provide leadership, guidance, and motivation to direct reports and project teams. Focus on developing strong leaders within the QC department, ensuring they are equipped to make critical decisions and meet project timelines
Proactively manage daily internal and external business which includes interactions with internal teams, CMO project leads, and management to plan, develop, and coordinate activities to set up/review/track and trend adventitious agent testing such as sterility, endotoxins, bioburden, micro-biological identification, particulate matter, and environmental monitoring
Develop and implement innovative technologies, methods, and processes for microbial analysis
Ensuring that all laboratory activities (internal and external) are conducted in compliance with relevant regulations and guidelines
Providing scientific leadership and technical expertise to the laboratory teams
Drive qualification, implementation and execution of micro USP methods for biological and small molecule product – includes in-process, release and stability
Support microbiology quality events
Author and/or review microbiology procedures including protocols and reports
Manage sample submission to third party for microbial identification
Manage and develop microbiology personnel and work closely with internal and external teams
Work closely with quality on defining and implementing aseptic techniques and cross contamination controls
Future management and oversight of the day-to-day operations of the microbiology laboratory, including sample processing, data analysis, and reporting. Undertake facility environmental trend reporting
Work with accuracy, urgency and a continuous improvement perspective
Represent Gilead as Microbiology subject matter expert. Interface with Regulatory agencies as required representing Gilead to authorities and regulatory inspectorates in matters relating to GxP
Qualification
Required
PhD with 8+ years of relevant experience in the pharmaceutical industry OR
Master's degree with 10+ years of relevant experience in the pharmaceutical industry OR
Bachelor's degree with 12+ years of experience in the pharmaceutical industry OR
Associate's degree with 14+ years of experience in the pharmaceutical industry OR
High School Degree with 16+ years of experience in the pharmaceutical industry
Preferred
4+ years of relevant experience in a GMP Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring
Must have experience with GMP systems (e.g. LIMS, QMS, SAP) and software such as Empower, JMP, Discoverant
Deep knowledge and experience in Biopharmaceutical or Pharmaceutical quality control. Stays ahead of shifting microbiological trends in industry
Prior senior leadership experience required
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
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
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
2025-12-30
BioWorld Financial Watch
2025-12-29
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