Senior Associate, Global External Manufacturing, Small Molecule Drug Substance

Job Description

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Senior Associate, Global External Manufacturing, Small Molecule Drug Substance

KEY RESPONSIBILITIES

Senior Associate, Global External Manufacturing, Small Molecule Drug Substance (DS) works to support uninterrupted supply of Gilead’s clinical and commercial products through execution of manufacturing campaigns within our global external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This position is part of the Manufacturing Operations group within the larger Pharmaceutical Development and Manufacturing organization (PDM).

This role requires collaboration with the Development, Quality, Regulatory, Analytical, Supply Chain, and Product & Portfolio Strategy organizations within PDM to ensure successful technology transfer, commercialization, launch, routine supply, and proactive management of changes across the product lifecycle.

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

Essential Functions

• Part of the team within Global External Manufacturing to execute the network strategy. Responsible for execution of the business with external manufacturing organizations, and management of supplier performance
• Effectively collaborates with functions within and external to PDM to achieve corporate, cross functional, and departmental goals
• Part of the team to define the technical requirements for selection of CMOs, and influences overall performance of the network CMOs to achieve Gilead’s strategic and tactical business outcomes, including Key Performance Indicators
• Participates in coordination of inter- and intra-company technical transfers. Partners with Technical Development and internal Gilead manufacturing sites for successful technology transfer and validation of new or existing processes/products to the identified CMO(s)
• Executes the regular, tactical management of CMOs to ensure Gilead’s products are manufactured in accordance with the registered process and approved Master Production Record
• Enables timely resolution of issues associated with manufacturing and/or compliance, including handling of deviations, complaints, out-of-specification investigations, Material Review Board associated investigations, finished product trending, and change control
• Fosters and facilitates continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability.
• May represent manufacturing on one or more cross-functional Development or Commercial CMC teams

QUALIFICATIONS

• Basic understanding of small molecule drug substance manufacturing and supply chain execution and oversight in the pharmaceutical industry
• Working understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP). Working knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance
• Knowledge of the contract manufacturing organization (CMO) landscape
• Ability to travel internationally, including overnight up to 10% of the time is required
• Exceptional verbal and written communication skills, including ability to interact effectively with senior management at Gilead and contract manufacturing organizations.
• Ability to understand and contribute to resolution of conflict in a constructive manner
• 5+ years of progressively responsible experience in a pharmaceutical/biotech organization and a BA or BS degree in science or engineering, an advanced degree in science or engineering is desirable
• An MS or MBA degree may be substituted for 2 years of relevant experience

Gilead Core Values

• Integrity (Doing What’s Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.