Sr Manager, Outsourced Manufacturing

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Senior Manager, Global External Manufacturing (GEM) Oral-Solid Dosage (OSD) supports 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 oversees, and contributes to, as required, technical and operational activities to ensure continued supply of clinical and commercial drug products manufactured by Gilead’s external contract manufacturing network.

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

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

Job Responsibilities :

Responsible, within GEM, to execute on Gilead’s supply network strategy; part of the team that defines the technical requirements for selection of CMOs.

Leads or represents GEM on one or more CMO Management Teams that influences overall performance of the CMO to achieve Gilead’s strategic and tactical business outcomes, including execution to plan, while monitoring Key Performance Indicators.

Proactively and effectively collaborates across functions within and external to PDM to achieve departmental, cross functional, and corporate goals.

Responsible for execution of inter- and intra-company technical transfers. Proactively partners with Technical Development, and internal Gilead manufacturing sites as needed, 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 complex technical issues associated with manufacturing, product quality and/or compliance, including finished product trending, continued process verification, out-of-trend, and out-of-specification investigations, change management, handling of deviations and product complaints.

Provides on-site technical support at CDMO sites as needed.

Identifies and facilitates execution of continuous improvement initiatives to reduce costs, improve quality, increase efficiency, and ensure sustainability of supply.

May represent GEM on one or more cross-functional PDM Development or Commercial teams with responsibility for proactively managing product strategy across the life cycle from clinical supply to commercial product launch, to routine supply, and finally to sunset or divestiture of the product.

Writes/reviews qualification/validation/technical and deviation reports. Prepares documents for Regulatory filings, and reviews filings, including sections from other disciplines.

 

Basic Qualifications:

8+ 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, engineering, or business is desirable.

An MS or MBA degree may be substituted for 2 years of relevant experience OR a Ph.D. degree may be substituted for 4 years of relevant experience.

Preferred Qualifications:

Strong computer, organizational, and project management skills required.

Experience and/or working understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP). Working knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance

Experienced in drug product manufacturing/technical operations and supply chain execution and oversight in the pharmaceutical industry.

Experience in manufacturing and quality risk management at external manufacturing sites.

Understanding of the contract manufacturing organization (CMO) landscape; knowledge of CMO capabilities and limitations for worldwide drug product manufacturing is a plus.

Ability to travel internationally, including overnight up to 20% of the time, is required.

Exceptional verbal, written and interpersonal communication skills, including ability to interact effectively with senior management at Gilead and contract manufacturing organizations.

Demonstrated ability to understand and contribute to resolution of complex situations.

Experienced in OSD drug product manufacturing and supply chain execution and oversight in the pharmaceutical industry.

Experience supporting regulatory inspections and audits in partnership with QA.

Advanced expertise in vendor qualification, contract negotiation, and supplier performance management.

The salary range for this position is: $157,590.00 - $203,940.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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