Executive Director Manufacturing Sciences & Technology, Biologics
We want the courageous, the self-starters, the compassionate doers, the make-it-possible-ers. Because those are the kind of people who are best able to make an impact for people with cancer. So, what’s missing? Just someone like you.
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
The Executive Director, Biologics MS&T will be responsible for overseeing the commercialization of Biologics and Anti-body Drug Conjugates (ADCs). The ED will provide leadership to an organization responsible for mAb upstream process, downstream process, conjugation, drug product process, and analytical operations. As the leader of all the MS&T functions for Biologics, this position represents a single point of CMC accountability for advancing Gilead’s Biologics commercial portfolio. In addition, the ED will be a member of the Biologics Leadership Team, which is responsible for providing leadership and decisions to the Biologics and ADC commercialization strategies and operation at the Morris Plains, NJ site.
- Build a MS&T organization and wet lab capabilities in support of growing Biologics and ADC commercial portfolio
- Provide leadership and direction to the Biologics MS&T organization
- Advance Biologics commercial support for Trodelvy and Ph2/3 assets by providing overall CMC oversight, direction, and decisions.
- Provide strategic directions to all Biologics programs to assess facility fit and long-term manufacturing footprint
- Serve as a senior member of the Biologics Leadership Team responsible for establishing commercial Biologics strategy and direct support to internal and external operations
- Partner with Biologics Process Development to ensure successful commercialization of the Biologics development portfolio
- Execution of process robustness assessments, product characterization studies and scale-down models, and continuous improvement programs
- In partnership with Process Development, execute mAb, DS, and DP PPQ studies across Gilead’s global manufacturing network
- Drive process and analytical method tech transfers, implementation of CPV program, and projects to improve project execution and data management
- Lead collaborations and complex investigations with Gilead Biologics functions such as Quality Assurance, Process Development, Biologics Business Support Organization, and Outsourcing
- Form and guide Biologics commercial (CMC) teams consisting of representatives from various functions, in support of BLA and global filings.
- Develop and motivate a team of highly capable, experienced SMEs to support objectives of the role in addition to prioritizing available resources, balancing urgent and the important activities, such that supply continuity is ensured by reducing process, technical or executional risks.
- Support regulatory agency interactions and product-related inspections
- Provide technical support to internal and external cGMP manufacturing operations
- Develop and manage department budget
- Masters or PhD in Chemical Engineering or related disciplines
- 15+ years of biopharmaceutical industry experience with no less than 10 years of that experience focusing on Biologics manufacturing/technical operations, focusing on process optimization utilizing mammalian/murine cell lines
- Experience leading cross-functional Biologics CMC teams consisting of representatives from multiple functions such as Upstream Process, Downstream Process, Drug Product Process Development, and Analytical Operations.
- Conjugation experience with ADCs strongly preferred.
- Experience supporting multiple regulatory filings including BLA/MAA and supporting product-related inspections for US and foreign regulatory agencies
- Experience developing, implementing and executing strategic plans and objectives for organizations and departments
- Experience working with external manufacturing and testing organizations
- In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of Biologics and/or ADCs
- Solid understanding of current industry trends and regulatory expectations associated with QbD, comparability evaluation, scale up, and method and process validation
- Exceptional interaction, leadership and command skills are required
- 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.
We offer a competitive salary and benefits package. Apply today at Executive Director Manufacturing Sciences & Technology, Biologics (myworkdayjobs.com)