Senior Manager, Global External Manufacturing, Biologics 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

Pharmaceuticals, BiotechnologyIndustries

Requirements

Experience in leading the manufacture of Biologics Drug Substance
Ability to collaborate at the Team Leadership level with Development, Quality, Regulatory, Analytical, Supply Chain, and Product & Portfolio Strategy organizations
Knowledge of cGMP, regulatory requirements, and environmental, health, and safety (EHS) legislations
Based at the Gilead Foster City campus

Responsibilities

Support uninterrupted supply of Gilead’s clinical and commercial products through execution of manufacturing campaigns within the global external contract manufacturing network, ensuring compliance with cGMP, regulatory requirements, and EHS legislations
Execute the network strategy, including tactical manufacturing strategy, execution of business with external manufacturing organizations, and management of supplier performance
Proactively lead collaboration with functions within and external to Pharmaceutical Development and Manufacturing (PDM) to achieve corporate, cross-functional, and departmental goals
Collaborate with Technical Development Organization to define technical requirements, partner with Global Supply Chain in CMO selection, and influence overall performance of network CMOs to achieve Gilead’s strategic and tactical business outcomes, including Key Performance Indicators
Coordinate inter- and intra-company technical transfers and partner with Technical Development and internal Gilead manufacturing sites for successful technology transfer and validation of new or existing processes/products to identified CMO(s)
Execute regular, tactical management of CMOs to ensure Gilead’s products are manufactured in accordance with the registered process and approved Master Production Record
Enable timely resolution of complex issues associated with manufacturing and/or compliance, including deviations, complaints, out-of-specification investigations, Material Review Board investigations, finished product trending, and change control
Foster and facilitate continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability
May represent the organization in relevant forums (incomplete in description)

Skills

Key technologies and capabilities for this role

Biologics ManufacturingcGMPRegulatory ComplianceContract ManufacturingSupply Chain ManagementManufacturing OperationsEHS Compliance

Questions & Answers

Common questions about this position

What is the salary for this Senior Manager position?

This information is not specified in the job description.

Is this role remote or office-based?

This position will be based at the Gilead Foster City campus.

What skills and experience are required for this role?

Experience in leading the Manufacture of Biologics Drug Substance is required, along with skills in executing manufacturing campaigns, ensuring cGMP compliance, managing supplier performance, and collaborating across functions like Development, Quality, Regulatory, and Supply Chain.

What is the company culture like at Gilead?

Gilead emphasizes collaboration, determination, and a relentless drive to make a difference, with people leaders driving an inclusive culture where employees feel developed and empowered. Every team member plays a critical role in scientific innovations to tackle major health challenges.

What makes a strong candidate for this position?

Strong candidates will have experience leading biologics drug substance manufacturing, expertise in cGMP compliance and supplier management, and the ability to collaborate effectively at a team leadership level across multiple functions.

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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