Director, Biologics Analytical Development (Pivotal and Commercial) at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Ph.D. with 8+ years in Mass Spectrometry or related fields of industrial experience in biologics analytical development and/or structural characterization with people leader accountabilities
M.S. with 10+ years in Mass Spectrometry or related fields of industrial experience in biologics analytical development and/or structural characterization with people leader accountabilities
Broad experience in analytical development from early development to commercial launch
Filing experience with FDA/EMA
In-depth technology understanding for biological products
Solid understanding of GMPs and CMC requirements
Mass Spectrometry experience (must)

Responsibilities

Provide leadership to a group of structural characterization scientists, including mentoring and guiding scientists, setting clear expectations and prioritization of work packages, and recruiting/hiring new talent
Define critical quality attributes (CQAs) across the late-phase biologics portfolio and build deep understanding of how CQAs relate to the product’s function
Drive continuous improvement of CQA identification strategies
Lead innovation in mass spectrometry initiatives to build a best-in-class structural characterization function
Lead higher order structure deliverables across the late-phase portfolio
Support the design/justification/execution of end-to-end control strategy development through proactive definition of product quality targets
Deliver high quality structural characterization work packages for supporting Pivotal INDs and marketing applications
Serve as an analytical project lead (ASTL) for late-phase programs overseeing all analytical deliverables
Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies
Collaborate across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development, and Technical Development to ensure timely delivery and successful commercialization of the late-stage Biologics portfolio
Act as a key member of the extended Analytical Development leadership team to shape late-stage development strategies
Demonstrate comprehensive knowledge in key analytical CMC strategic areas including CQAs, separations methods, method bridging, reference standard, comparability, and specifications
Drive adoption of novel and state-of-the-art structural characterization technologies and approaches
Recruit, hire, and mentor talent to cultivate a world class Biologics AD organization

Skills

Mass Spectrometry

Structural Characterization

Biologics Analytical Development

GMP

CMC

FDA Filing

EMA Filing

Analytical 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.

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