Scientist — Quality Control Biologics (Analytical Lifecycle Management) at Gilead Sciences

Foster City, California, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

BiopharmaceuticalIndustries

Requirements

Extensive knowledge of Quality Control sub-functions
In-depth understanding and application of GMP principles, concepts, practices, and standards in the US and internationally
Ability to develop and improve complex concepts, techniques, and standards
Ability to develop solutions to complex problems requiring ingenuity, creativity, and innovativeness
Ability to exercise judgment and independently determine and take appropriate action where precedent may not exist

Responsibilities

Support strategic leadership and oversight of daily operations for Clinical Biologics QC
Support the development of clinical specification strategies
Support programs related to reference standards, raw materials, and critical reagents
Support analytical method validations and transfers
Contribute to the compendial review program
Monitor QC test method execution
Lead the analytical lifecycle management of Clinical biologics drug substances and drug products
Contribute to monitoring industry best practices and trends

Skills

GMP

Quality Control

Analytical Method Development

Method Validation

Method Transfer

Biologics

Reference Standards

Specification Strategies

Compendial Review

QC Test Methods

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