Sr Director, Antibody Conjugates, CMC Portfolio Management

Johnson & Johnson is recruiting for a Senior Director, Antibody Conjugates, CMC Portfolio Management located in Malvern, PA.

This leadership position will lead the Antibody Conjugate CMC leaders while also serving as a CMC Leader in TDS supporting and influencing 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 the antibody conjugate portfolio.

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 Global People Leader 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 advice on early development through commercialization, plans for conjugated protein portfolio assets, and oversight of Business Development due diligence activities in this area.

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 Management and Strategy Leadership Team.
Key Responsibilities:


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

Lead the CMC Portfolio Management team accountable for the Antibody Conjugate portfolio.


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


* Attract and develop high performing diverse talent through development of functional CMCL, smart talent acquisition and strong training and development approaches.


* Provide scientific direction, strategy, and mentorship to scientific leaders for products in development.

Ensures staff are properly trained for their role as CMCL.


* 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 antibody conjugate portfolio.


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


* Negotiates and solicits acceptance of new ideas, approaches, concepts through programmatic leadership and acts as an internal expert with a direct impact on IMRD/IMSC portfolio and/or business objectives; Owns portfolio escalations and stakeholder man...