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Director, Cell & Gene Therapy CMC Leader - Large Molecule Biologics
Malvern, Pennsylvania; Spring House, Pennsylvania
Requisition ID: 1126180509
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Director, located in Malvern, PA or Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Director within the Portfolio Management group will be responsible for leading multiple CMC Teams end-to-end, spanning from pre-NME to post-BLA/MAA Approval, including Life Cycle Management (LCM). This includes, but is not limited to, the creation and implementation of the development strategy, the adherence to the CMC 12 Stage Gate process, approval by governance bodies, the identification and mitigation of CMC risks, the completion of required CMC regulatory documents and responses, creation and adherence to budget and timelines, and the delivery of clinical and launch drug supplies in accordance with development plans. The Director is also the CMC point of contact with the Compound Development Team(s) (CDT) in which the ability to understand the overall compound strategy and lead the creation of a CMC strategy to fit this strategy is key. Additional responsibilities include but are not limited to the following:
- Find solutions and lead the CMC team in a way that balances both the needs of both the functions and our stakeholders
Be an advocate for the functions who perform the CMC development, a valued strategic partner to our stakeholders, the CDT’s who report into the Therapeutic Areas and the VSTs (Value Stream Teams)
- Demonstrate behaviors consistent with the current Leadership Imperatives
- Mentoring and coaching CMC Team Members to improve their skills and contributions to the organization in collaboration
- Focus on the compound development projects but may also identify and lead portfolio process improvement type projects due to their expected strength in matrix leadership
A Bachelor's degree in life science or related field with at least 8 years of experience in pharmaceutical, biotechnology or a related industry OR a Master's degree in life science or related field with at least 6 years of experience in pharmaceutical, biotechnology or a related industry OR a Ph.D. with at least 4 years of experience in pharmaceutical, biotechnology or a related industry is required
Large Molecule CMC development experience is required
Cell therapy and/or gene therapy CMC development experience is strongly preferred
Experience in setting development and regulatory strategies for products in development is required
North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)