Senior Manager, Global External Manufacturing- Sterile DP & Biologics

About this role

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   At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. 

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.  As a Senior Manager, Global External Manufacturing at Gilead you will support the 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). Experience in leading the Manufacture of Sterile Drug Products is a must.

This role requires collaboration at the Team Leadership level 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

Functions : • Accountable for the execution of the tactical manufacturing strategy and all technical/operational activities related to maintaining clinical and commercial product supplies through management of external resources.

• Accountable for the technical lifecycle management of commercial products including both intra and inter technology transfers, scale-up, process validation and continuous process validation.

• Provides technical expertise in parenteral manufacturing unit operations including; thawing, compounding, filtration, aseptic filling, lyophilization, capping, terminal sterilization, visual inspection and sterility assurance.

• Co-leads commercialization activities at external partners for new products in conjunction with the process development team. Provides support for process development activities at external partners.

• Leads and coordinates the Gilead cross functional CxO team.

• Leads activities at manufacturing sites, including providing project timelines, resolving issues, on-site troubleshooting, and providing overall technical support; may negotiate pricing for limited-scope projects.

• Leads technical investigations and assessment of deviations and CAPA’s.

• Defines requirements for, and reviews master batch records and change controls.

• Coordinates equipment/process qualification (IQ/OQ/PQ) and executes process validation (PV); writes, reviews and/or approves qualification/validation/technical reports.

• Responsible for the development, distribution, updating and maintenance of the technical database for all CMO’s currently used by the company in the manufacturing of commercial products.

• Responsible for tracking and updating senior management on the routine manufacturing of commercial products providing guidance on potential problems and their resolution.

• Supports the product CMC team as the sitting manufacturing representative. Authors documents for Regulatory filings, and review filings, including sections from other disciplines. Responsible for the technical review of pertinent CMC sections of global regulatory filings.

• Manages complex processes across functions and interacts effectively with the other team members to ensure product meets regulatory, performance, and cost requirements.

• Provides technical guidance and training to junior group members.

Experience: • Experience in sterile drug product manufacturing and supply chain execution and oversight in the pharmaceutical industry

• Experience in supply risk management. Possesses knowledge of industry and system best practices

• Experience and/or working understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP)

• Solid knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance

• Understanding of the contract manufacturing organization (CMO) landscape

• Knowledge of CMO capabilities and limitations for worldwide bulk drug substance manufacturing is a plus

Requirements : • 8+ years of progressively responsible experience in a pharmaceutical/biotech organization and a BA or BS degree in science or engineering required OR

• 6+ years of progressively responsible experience in a pharmaceutical/biotech organization and a MS degree in science or engineering required OR

• 2+ years of progressively resp

Similar jobs

• Associate Director, Strategic Sourcing & Supplier Management, Sterile Drug Product and Biologics — "Gilead Sciences · Foster City, California, United States
• Head of Global Product Quality- Biologics — Biibhr · Cambridge, MA
• Senior Manager, Contract Manufacturing — Thefarmersdog · New York, New York, United States
• Manufacturing Supervisor – Aseptic Upstream Bioprocessing — Elanco · Elwood, KS
• Sr. Director, Sterility Assurance – Global Quality Technical Operations — PCI Pharma Services · Remote
• Senior Manager, Project Manager - Biologics — Bristol Myers Squibb · Devens, MA
• Senior Manager, Manufacturing Engineering — Formenergy · Weirton, WV
• Senior Manager, Manufacturing Engineering — Epirus · Torrance, California, United States