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 responsible experience in a pharmaceutical/biotech organization and a PhD in science or engineering required
- Exceptional verbal and written communication skills
- Sound organizational and time management skills
- Ability to effectively manage multiple priorities
- Working knowledge of GMPs and associated regulations
- May participate and support QA in audits.
- Ability to interact effectively with senior management
- Ability to travel internationally, including overnight up to 10% of the time is required
People Leader Accountabilities:
- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
