Sr. Director - CMC Project Management, Biologic Modalities
Eli Lilly and Company, Indianapolis, IN, United States
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. **Position Summary:**The Senior Director, CMC Project Management will provide strategic and operational leadership for cross-functional CMC team(s) and will partner with CMC scientific and technical leaders with accountability for technical deliverables. CMC Project Management is the program and project management arm of our critical Product Research and Development group. CMC Project Managers are responsible for leading the creation, development, communication, and implementation of integrated CMC plans for assets from portfolio entry to global submissions/approvals and launch. **Responsibilities:**Leverage portfolio knowledge, development, and financial acumen to enable investment strategy and optimization at both project and portfolio level.
ability to quickly **Basic Requirements:**
of 10+ years of industry biologic modality drug development/commercialization experience with BS/BA degree or minimum of 5 years of industry biologic molecule drug development experience with an advanced degreeDemonstrated deep technical knowledge and experience of biologic modality drug development, commercialization and manufacturing processes, including biologics modalities
modalities
(monoclonal antibodies) and advanced Gene & Cell therapeutics (adeno-associated virus, mRNA-LNP, CAR-T, allogeneic and autologous cell therapies) Practical experience (formal or informal) in project management of cross-functional projects Demonstrated ability to lead cross-functional team(s) and together solve complex problems Demonstrated ability to rapidly become proficient in new tools Demonstrated ability to communicate complex issues timely, accurately, and succinctlyThis role requires relocation and on-site presence at the Indianapolis facilities Experience with early and late-stage product development including knowledge of the global regulatory submission/approval process for biologic modalities, including conventional biologics and advanced Gene & Cell therapeuticsMust have demonstrated strong leadership, communication, risk management, and decision making skills At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.
We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #J-18808-Ljbffr
ability to quickly **Basic Requirements:**
of 10+ years of industry biologic modality drug development/commercialization experience with BS/BA degree or minimum of 5 years of industry biologic molecule drug development experience with an advanced degreeDemonstrated deep technical knowledge and experience of biologic modality drug development, commercialization and manufacturing processes, including biologics modalities
modalities
(monoclonal antibodies) and advanced Gene & Cell therapeutics (adeno-associated virus, mRNA-LNP, CAR-T, allogeneic and autologous cell therapies) Practical experience (formal or informal) in project management of cross-functional projects Demonstrated ability to lead cross-functional team(s) and together solve complex problems Demonstrated ability to rapidly become proficient in new tools Demonstrated ability to communicate complex issues timely, accurately, and succinctlyThis role requires relocation and on-site presence at the Indianapolis facilities Experience with early and late-stage product development including knowledge of the global regulatory submission/approval process for biologic modalities, including conventional biologics and advanced Gene & Cell therapeuticsMust have demonstrated strong leadership, communication, risk management, and decision making skills At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.
We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #J-18808-Ljbffr