Scientist — Quality Control Biologics- Reference Standard Lead at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

BiopharmaceuticalIndustries

Requirements

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
Preferred: Experience developing and/or leading reference standard and critical reagent programs for commercial or late-stage biologics drug substances and drug products
Preferred: Experience authoring reference standards

Responsibilities

Provide strategic leadership and oversight of daily operations for Commercial Biologics QC
Support Commercial reference standard, raw materials, and critical reagents programs, and specification strategies
Contribute to monitoring QC test method execution
Lead the analytical lifecycle management of Commercial biologics drug substances and drug products
Develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories
Develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness
Exercise judgment and independently determine and take appropriate action where precedent may not exist
Work with senior management to develop and ensure the implementation of Company-wide long-term solutions
Motivate and engage individuals
Influence process and outcomes across functions
Support future laboratory work
Support Commercial QC team

Skills

Biologics QC

Reference Standards

Analytical Lifecycle Management

Raw Materials Management

Quality Control

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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