Assoc Director, Outsourced Manufacturing
About The Position
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.
Requirements
- Bachelor’s degree (BA or BS) in Organic Chemistry, Chemical Engineering, or another relevant scientific discipline with at least 10+ years of relevant, progressively responsible experience managing external sites OR Master's degree in Organic Chemistry, Chemical Engineering, or another relevant scientific discipline with at least 8+ years of relevant, progressively responsible experience managing external sites
- Strong working knowledge of pharmaceutical GMPs and ICH regulatory guidance.
- Demonstrated experience managing external suppliers, contract manufacturers, warehouses, or logistics providers.
- Proven ability to interact effectively with senior management and cross-functional teams.
- Exceptional verbal and written communication skills.
Nice To Haves
- Experienced in OSD drug product manufacturing and supply chain execution and oversight in the pharmaceutical industry
- Understanding of the contract manufacturing organization (CMO) landscape; knowledge of CMO capabilities and limitations for worldwide drug product manufacturing is a plus
- Experience in application of manufacturing principles governed by current Good Manufacturing Practices (cGMP). Working knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance
- Experience supporting regulatory inspections and audits in partnership with QA.
- Advanced expertise in vendor qualification, contract negotiation, and supplier performance management
Responsibilities
- Executes the regular, tactical management of CMOs to ensure Gilead’s Oral Solid Dose (OSD) products are manufactured in accordance with the registered process and approved Master Production Record
- Enables timely resolution of complex 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
- Responsible for coordination of inter- and intra-company technical transfers. Proactively 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)
- Foster and facilitate continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability.
- Represent manufacturing on one or more cross-functional Development or Commercial CMC teams, as needed, with responsibility for proactively managing product strategies across the life cycle from clinical supply, to commercial product launch, to routine supply, and then to either divestiture or sunset.
- Confer with vendors to analyze their operations, technical capabilities and capacity to assess factors affecting pricing to negotiate competitive cost consistent with quality, reliability, and schedule requirements.
- Facilitate production schedules based on downstream operational and program requirements; proactively communicate supply risks and schedule delays to project teams.
- Apply solid working knowledge of relevant regulatory guidance, including pharmaceutical GMPs and ICH guidelines.
- Participate in Quality Assurance–led regulatory and compliance audits, as needed.
- Support department leadership with resource planning and financial reporting activities.
- Communicate effectively with senior management through clear, concise written and verbal updates.
- Apply sound organizational and time management skills to manage multiple priorities effectively.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
