As a director within the CMC Leadership group you will lead multiple cross-functional CMC (Chemistry Manufacturing & Controls) Teams. CMC Teams develop, execute, align and communicate the CMC strategy of a program. Programs span from pre-NME to post-NDA/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 and approval by governance bodies. As well as 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. You are also the CMC point of contact and member of the Compound Development Team(s) (CDT) who sets the overall compound strategy from Discovery to Commercial. Understand this strategy and own the creation of a CMC strategy to fit this strategy is key.
You are an advocate for the functions who perform the CMC development (e.g. API Development, Analytical Development, Drug Product Development, Quality, Project Management, CMC Regulatory Affairs, and Supply Chain), and a valued strategic partner to our stakeholders, the CDT’s who report into the Therapeutic Areas. For LCM projects, our partner is the Janssen Supply Chain. You will find solutions and be responsible for the CMC team in a way that balances both the needs of both the functions and our partners.
You are focused on the CDT projects but may also identify and lead portfolio process improvement type projects due to their expected strength in matrix leadership.
You can demonstrate behaviors consistent with the current J&J Leadership Imperatives, Connect, Shape and Grow with at the center our Credo and Our Purpose.
- A Master's degree in life science or related field with at least 15 years of experience in pharmaceutical, biotechnology or a related industry OR a Ph.D. with at least 10 years of experience in pharmaceutical, biotechnology or a related industry.
- Small Molecule CMC development experience and in depth scientific knowledge of CMC -development and Manufacturing.
- Excellent communication skills, both oral and written, as well as conflict management and negotiation skills.
- You have excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures and dynamics.
- Experience in setting development and regulatory strategies for products in development.
- You have shown capability to handle multiple projects.
- You can make difficult decisions in a timely fashion along with excellent follow through and organizational skills to assure team and organizational alignment to these decisions.
- You can influence partners without line authority is required.
- You have a good business insight.
What’s in it for you…?
“Caring for the world, one person at a time…”
As an employee we consider you as our most valuable asset. We take your career seriously. As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future! We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Janssen Pharmaceutica N.V. (7555)