Scientist, Analytical Ops at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Ph.D. with 3+ years or M.S. with 6+ years in Analytical Chemistry or related fields of industrial experience in biologics analytical development
Advanced expertise and hands-on experience with LC-MS based biologics characterization and data analysis to support CMC process development
Experience with analytical method development, validation, and control strategies of biologic products (e.g. HPLC, CE-SDS, iCIEF, LC-MS/MS, intact/reduced/sub-units mass, gel electrophoresis, etc.)
Familiar with FDA and ICH

Responsibilities

Lead and support analytical characterization activities for pre-pivotal (Toxicology, Phase I/II) biologic molecules. Identify molecule critical quality attributes, propose and justify analytical control strategies, author relevant regulatory filings for biologic drug substance and drug product
Lead the development of advanced extended characterization methods utilizing state-of-the-art mass spectrometry technologies including (but not limited to) Native LC-MS, CE-MS, MD-LC-MS, affinity LC-MS, and automated high-throughput LC-MS/MS, for pre-pivotal (Phase I/II) biologics
Develop analytical methods to be used for molecule characterization and/or release testing (using HPLC-UV, CE, HPLC-FLR, iCIEF, HPLC-CAD, etc.). Author associated method development reports, test procedures, validation protocols and reports
Proactively evaluate and implement state of the art technologies to drive innovation in Analytical Development and testing
Oversee and advise data generation / data integrity and ensure compliance and analytical excellence from internal and outsourced testing at contract organizations
Maintain strong relationships with key stakeholder functions and work cross-functionally with colleagues in Research, Clinical Development, and Clinical Supply Management and Program Strategy Teams by providing technical and strategic input
Provide technical support to internal and external cGMP manufacturing operations
Present research findings and recommendations to senior staff, prepare research reports and peer-reviewed manuscripts, and contribute to the preparation of INDs, and patent filings

Skills

Key technologies and capabilities for this role

analytical characterizationbiologics developmentpre-pivotal developmentpharmaceutical developmentToxicology studiesPhase I/IIstate-of-the-art technologiesinnovative methodologies

Questions & Answers

Common questions about this position

What is the location for this Scientist position?

The position is based in Foster City, CA at Gilead Sciences.

What salary or compensation is offered for this role?

This information is not specified in the job description.

What key skills and expertise are required for this Scientist role?

The role requires expertise in analytical characterization of biologics, development of advanced mass spectrometry methods like Native LC-MS and CE-MS, and analytical methods using HPLC-UV, CE, and iCIEF. Experience leading analytical activities, authoring regulatory filings, and ensuring data integrity is essential.

What is the company culture like at Gilead?

Gilead emphasizes collaboration, determination, and a relentless drive to make a difference, with a focus on creating an inclusive environment where employees feel developed and empowered. People Leaders are key to evolving the culture and supporting employee aspirations.

What makes a strong candidate for this Scientist position?

A talented and highly motivated individual with experience in analytical development for pre-pivotal biologics, expertise in state-of-the-art mass spectrometry and analytical methods, and the ability to lead project teams and drive innovation will stand out.

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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