Johnson & Johnson Careers
CMC Leader, Associate Director / Director
Malvern, Pennsylvania; Leiden, Netherlands; Spring House, Pennsylvania
Requisition ID: 4529190117
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 Associate Director/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 Associate Director/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 lead 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 Associate Director/Director is expected to 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 Associate Director/Director is expected to find solutions and lead the CMC team in a way that balances both the needs of both the functions and our stakeholders.
The Associate Director/Director is expected to demonstrate behaviors consistent with the current J&J Leadership Imperatives. At the Director level, 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 Associate Director/Director is primarily focused on the compound development projects, but may also identify and lead portfolio process improvement type projects due to their expected strength in matrix leadership.
Cell therapy and/or gene therapy CMC development experience is strongly preferred.
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. More experience is expected for a Director level role.
Large Molecule CMC development experience is required.
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, North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)