Johnson & Johnson Careers
Director CMC Leader
Malvern, Pennsylvania; Leiden, Netherlands; Spring House, Pennsylvania
Requisition ID: 1126190307
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a CMC Leader, Associate Director / Director. This position can be located in Malvern, PA, Spring House, PA or Leiden, Netherlands.
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.
The Director within the Portfolio Management group will be responsible for leading multiple cross-functional CMC (Chemistry Manufacturing & Controls) 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 Janssen 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 and member of the Compound Development Team(s) (CDT) in which the ability to understand the overall compound strategy and own the creation of a CMC strategy to fit this strategy is key. 30 – 90 people in the group. No direct reports. An all matrix leadership.
The Director will be an advocate for the functions who perform the CMC development (e.g. API Development, Analytical Development, Drug Product Development, Quality, Project Management, CMC RA, and Supply Chain), and a valued strategic partner to our stakeholders, the CDT’s who report into the Therapeutic Areas. For LCM projects, our stakeholders are the VSTs (Value Stream Teams) who report into Janssen Supply Chain. The Director will need to find solutions and lead the CMC team in a way that balances both the needs of both the functions and our stakeholders.
The Director will demonstrate behaviors consistent with the current J&J Leadership Imperatives. This person may have direct reports, other CMC Leaders, and be responsible for mentoring and coaching CMC Team Members to improve their skills and contributions to the organization.
The Director will focus on compound development projects, but may also identify and lead portfolio process improvement projects due to their expected strength in matrix leadership.
- Cell therapy and/or gene therapy and/or CAR-T therapy is required.
- 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.
- CMC development experience is strongly preferred.
- Excellent communication skills, both oral and written, as well as proven conflict management and negotiation skills are required.
- Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures and dynamics are required.
- Experience in setting development and regulatory strategies for products in development is required.
- Demonstrated capability to manage multiple projects is required.
- Demonstrated ability to make difficult decisions in a timely fashion along with excellent follow through and organizational skills to assure team and organizational alignment to these decisions is required.
- Demonstrated ability to influence stakeholders without line authority is required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)