Principal Scientist, Quality Control Lead, Small Molecules at Gilead Sciences

Foster City, California, United States

Apply Now

Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Deep technical expertise in analytical chemistry and cGMP operations
Strong understanding of phase-appropriate quality control strategies and requirements
Ability to collaborate cross-functionally to enable successful delivery of clinical supply and development milestones

Responsibilities

Define, implement, and continuously improve the QC strategy for small molecule clinical development programs in alignment with overall CMC and quality objectives
Serve as the point of contact for overall QC activities including method validation and transfer, reference materials, specifications, cGMP release testing, stability strategy and testing, and supervision of testing at external contract testing laboratories
Develop and maintain phase-appropriate QC strategies and processes to support manufacturing and regulatory submissions
Manage and approve specifications, collaborating cross-functionally to establish scientifically sound and phase-appropriate specifications aligned with analytical capability, process understanding, and clinical and regulatory expectations
Represent QC on cross-functional product development teams, providing technical input and direction for analytical and quality decisions
Identify and drive opportunities for improvement in QC testing, workflows, data management, and compliance processes
Proactively identify and escalate potential QC risks, and communicate QC activities, risks, and issues to relevant stakeholders
Oversee and ensure compliant execution of QC testing for raw materials, intermediates, drug substance, and drug product
Ensure timely creation, review, and approval of QC documentation including test methods, protocols, reports, CoAs, and quality records
Provide QC oversight to contract testing laboratories, coordinating testing activities for on-time delivery and confirming compliance with cGMP and data integrity expectations
Direct and oversee timely resolution of QC testing related investigations with comprehensive root-cause analysis, risk assessment, and effective CAPAs
Ensure QC operations comply with cGMP, FDA, EMA, ICH, and other applicable regulations
Drive excellence in data integrity, documentation practices, and traceability across QC activities

Skills

cGMP

analytical chemistry

small molecules

quality control

analytical testing

data integrity

regulatory compliance

clinical development

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.

Land your dream remote job 3x faster with AI

Try Jobo Free