Sr Distinguished Scientist, CMC and Innovation Leader

Johnson & Johnson is recruiting for a Senior Distinguished Scientist, CMC and Innovation Leader role based in Malvern, PA with the option of being remote.

This individual will lead innovation strategy as a matrix leader across Therapeutic Development & Supply (TDS) and will lead one or more radioligand therapy CMC programs in TDS as a CMC Leader.

As a matrix leader, will support and influence all aspects of the E2E compound development from pre-NME to post-BLA/MAA approval, including Life Cycle Management, with oversight of the development strategy and associated budgets and timelines for their program(s).

In addition, the role will oversee CMC regulatory submissions and responses to deliver clinical and launch drug supplies in accordance with development plans, provide leadership and facilitate strategy development and implementation.

This role is an independent contributor with no direct reports.

The role will provide guidance on a broad range of topics in support of innovation, new business and cross-functional initiatives in support of the TDS and DPDS strategic vision.

This includes leadership and oversight of innovation within the TDS functions to enhance efficiencies in development through commercialization.

The role will build strategic partnerships and alliances to align with portfolio growth and innovation strategy in collaboration with other TDS operational groups and Innovative Medicine Supply Chain.

The role will work cross-functionally with other leaders within TDS, DPDS, and partner across the Therapeutic Areas, Global Clinical Operations, and IMSC for the timely and efficient delivery on projects.

The position reports to VP, Global Head of CMC Portfolio Strategy and is a fulltime member of the CMC Portfolio Strategy Leadership Team.
Key Responsibilities:


* Develop and implement E2E strategies for delivery of the radioligand portfolio.

Serve as a CMC Leader of one or more radioligand programs.


* Provide strategic and operational leadership to CMC team and manage PD OOPs budget in support of the portfolio.


* Lead innovation across TDS as a matrix leader.

Negotiates and solicits acceptance of innovative ideas, approaches, concepts through programmatic leadership as an internal expert with a direct impact on IMRD/IMSC portfolio and/or business objectives.

Acts as a scientific mentor for project teams and individuals.

Independently identifies and analyzes high-impact, complex and cross-functional challenges and gaps across the radioligand portfolio.


* Significantly improves, changes, or develops new business/work processes to share knowledge, build intellectual capital, and promote innovation in the radioligand portfolio.


* Influences across disciplines with senior leaders and external colleagues/ partners to drive and align strategic and operational activities across regions, therapeutic/functional areas.


* Collaborate with Business Development for Due Diligence activities, and clinical, regulatory, I...