VP, Commercial Biologics Operations
The Vice President, Commercial Biologics Operations is responsible for the end to end manufacturing, testing, and supply of commercial biologics. The VP is also accountable for strategy and successful implementation of regulatory content of all CMC aspects for all territories. As a member of the Pharmaceutical Development & Manufacturing (PDM) Extended Leadership Team, the VP is accountable to ensure the biologics manufacturing and life cycle operational plans are in alignment with PDM vision and strategies. The VP is responsible for leading Gilead's Commercial Biologics Operations organization, inclusive of Technical Operations, External and Internal QC.
- Lead and direct the overall commercial biologics organization, operating model, and culture
- Ensure quality and compliance, commercial supply, and robust and resilient operations across Gilead's evolving commercial biologics portfolio
- Lead biologics infrastructure and manufacturing/testing network strategy
- Lead the evolution of Gilead's Commercial Biologics Operations organization, evolving people, capabilities and infrastructure to meet future needs. Build organizational capabilities across Technical Operations, External and Internal QC.
- Establish a culture of collaboration and communication, high performance, operational excellence, and inclusion.
- Partner closely with stakeholders across Gilead, including Biologics Development, Quality, Supply Chain, Commercial Sales & Marketing, Alliance Management, Finance, Global Product Strategy, and Corporate Operations for ensuring successful biologics commercialization and manufacturing and testing strategy
- Establish collaborative, effective relationships with key external partners, including executive leaders of key CMOs and alliance partners
- Ensure successful maintenance and global expansion of biologics marketing authorizations by working in collaboration with other functional areas
- Contributing member of PBO and PDM leadership teams to ensure alignment of strategies across organizations.
- Establish and enhance tight collaboration between biologics development and commercial biologics organizations to ensure continued supply of biologics to patients throughout the development and commercial product lifecycle
- Prepare for and oversee operations for biologics projects in the development portfolio, including mAbs, antibody drug conjugates, recombinant proteins and therapeutic virus vaccines, from commercialization through long-term supply
- Ensures regulatory and EH&S requirements are met in the day to day operations of all activities in the commercial manufacturing network
- Ensure highest level of Quality and Compliance across all operational areas­.
- ­Accountable for the department budget, minimizing write-off losses and ensuring resources are allocated efficiently consistent with organizational needs and corporate goals
- Assign resources according to business priorities and project needs
- MS or PhD in Chemical Engineering, Biotechnology, or related disciplines
- 15+ years of biopharmaceutical industry experience with 10+ years of that experience focusing on biologics process development, technical operations and/or manufacturing
- Broad knowledge of the biopharmaceutical industry, including in-depth knowledge of the processes and functions involved in biologics commercial manufacturing
- Fluent in the process development and manufacturing of monoclonal antibodies and standard unit operations
- Experience leading corporate-wide cross-functional teams
- Experience supporting multiple regulatory filings including BLA/MAA and supporting product-related inspections for US and foreign regulatory agencies
- Experience developing and executing strategic plans and objectives for organizations and departments
- In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of biologics
- Exceptional interaction, leadership and command skills are required with results-oriented focus
- Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence, and strong communication skills
- Able to manage and lead a group of diverse individuals and mentor talent that encourages team to present and debate their best ideas and holds the team accountable for results
Gilead Core Values
- Integrity (Doing What's Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
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