Director, Quality Control Microbiology- Biologics/Small Molecules at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Strategic leadership and oversight of daily microbiological operations for biologics and small molecules
Commitment to personnel interactions, approachability, and mentoring staff for project completion and regulatory compliance
Ability to collaborate with cross-functional teams, CTLs, and foster continuous improvement
Expertise in adventitious agent testing (sterility, endotoxins, bioburden, microbiological identification, particulate matter, environmental monitoring)
Knowledge of relevant regulations and guidelines for laboratory compliance
Technical expertise in microbial analysis, USP methods for biological and small molecule products (in-process, release, stability)
Experience with qualification, implementation, and execution of microbiological methods
Ability to author/review microbiology procedures, protocols, and reports
Skills in managing sample submission to third parties for microbial identification
Capability to manage and develop microbiology personnel and work with internal/external teams
Proficiency in defining/implementing aseptic techniques and cross-contamination controls
Experience in facility environmental trend reporting and data analysis

Responsibilities

Lead development and implementation of end-to-end QC microbiological strategies for biologics and small molecules, including specifications for cell banks, products, raw materials, environmental monitoring/facilities, across clinical to commercial lifecycle
Lead and develop teams, providing leadership, guidance, motivation to direct reports and project teams, and building strong leaders in QC
Proactively manage daily internal/external business interactions with teams, CMO project leads, and management to plan, develop, coordinate, set up/review/track/trend adventitious agent testing
Develop and implement innovative technologies, methods, and processes for microbial analysis
Ensure all laboratory activities (internal/external) comply with relevant regulations and guidelines
Provide scientific leadership and technical expertise to laboratory teams
Drive qualification, implementation, and execution of micro USP methods for biological and small molecule products (in-process, release, stability)
Author and/or review microbiology procedures, protocols, and reports
Manage sample submission to third parties for microbial identification
Manage and develop microbiology personnel and collaborate closely with internal/external teams and quality on aseptic techniques/cross-contamination controls
Oversee day-to-day operations of microbiology laboratory, including sample processing, data analysis, reporting, and facility environmental trend reporting
Work with accuracy, urgency, and a continuous improvement perspective
Represent Gilead

Skills

Quality Control

Microbiology

Biologics

Small Molecules

Regulatory Compliance

Team Leadership

Mentoring

Strategic Planning

Cross-Functional Collaboration

Continuous Improvement

Gilead Sciences

Develops and commercializes biopharmaceuticals

About Gilead Sciences

Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.

Foster City, CaliforniaHeadquarters

1987Year Founded

$15,873.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Paid family time off and paid parental time off

Generous 401(k) contribution matching

Comprehensive medical plans that cover both physical and mental healthcare

Global Wellbeing Reimbursement

Time Off

Global Volunteer Day

Giving Together Program

Employee Support Programs

Flexible Work Options

Risks

Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.

Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.

Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.

Differentiation

Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.

Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.

Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.

Upsides

Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.

Investment in digital health technologies enhances Gilead's R&D and patient engagement.

Focus on sustainability improves Gilead's operational efficiency and corporate reputation.

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