Director, Global External Manufacturing, OSD at Gilead Sciences

Foster City, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Experience managing, training, and mentoring staff
Intimate collaboration at the Team Leadership level with Development, Quality, Regulatory, Analytical, Supply Chain, and Product & Portfolio Strategy organizations
Experience in tactical manufacturing strategy, execution with external manufacturing organizations, and supplier performance management
Ability to partner in development of department strategy aligned with corporate and PDM goals
Expertise in defining technical requirements, CMO selection, and influencing CMO network performance including KPIs
Knowledge of technology transfer and validation of processes/products to CMOs
Skills in regular tactical management of CMOs to ensure manufacturing per registered process and Master Production Record
Capability to resolve complex manufacturing and compliance issues (deviations, complaints, OOS investigations, MRB, trending, change control)
Ability to foster continuous improvement in production and business processes for cost reduction, quality improvement, efficiency, and sustainability
Potential to represent Gilead as liaison with governmental agencies
Compliance with cGMP, regulatory requirements, and EHS legislations

Responsibilities

Leads a team to ensure uninterrupted supply of Gilead’s clinical and commercial OSD products through execution of manufacturing campaigns in the global external contract manufacturing network
Performs as a leader within Global External Manufacturing to execute the network strategy
Responsible for tactical manufacturing strategy, execution of business with external manufacturing organizations, and management of supplier performance
Partners in development of department strategy aligned with corporate and PDM goals into functional/departmental objectives
Proactively leads collaboration with functions within and external to PDM to achieve corporate, cross-functional, and departmental goals
In collaboration with Technical Development Organization, defines technical requirements and partners with Global Supply Chain in CMO selection, influencing overall CMO network performance
Proactively partners with Technical Development and internal Gilead sites for successful technology transfer and validation to CMOs
Leads regular tactical management of CMOs to ensure products are manufactured per registered process and approved Master Production Record
Enables timely resolution of complex manufacturing/compliance issues, including deviations, complaints, OOS investigations, MRB, trending, and change control
Fosters and facilitates continuous improvement of production and business processes
May represent Gilead as liaison with governmental agencies

Skills

cGMP

OSD Manufacturing

Contract Manufacturing

Supply Chain Management

Regulatory Compliance

Team Leadership

Quality Assurance

Pharmaceutical Manufacturing

GMP Compliance

EHS

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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