CMC Leader

工作内容

Janssen Research & Development seeks to drive innovation and deliver transformational medicines to address and solve unmet medical needs through the development of small and large molecules, as well as vaccines. Small Molecules Product Development, the CMC organization within Janssen research & Development, is employing several hundreds of scientific researchers and specialized technicians at its site in Antwerp, Belgium. 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. As a CMC Leader 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 your expected skills 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. Qualifications A Master’s or Ph.D degree in life science or related field with at least 10 to 15 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. 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. Shown capability to handle multiple projects. Being able to make difficult decisions in a timely fashion along with excellent organizational skills to assure team and organizational alignment to these decisions. Being able to influence partners without line authority. Having a good business insight. What is in it for you? Contributing to our mission to continue to bring transformational new medicines to patients for a world without disease. Being part of a motivated and experienced research team in an innovative working environment Through mentoring programs, e-university and on the job training, we ensure your personal development in a global company A competitive salary, on-site sport accommodations, health/energy programs and other benefits for you and your family Flexible working hours (40 h/week), no fixed holiday planning with 39 holidays and possibility to work at home for non-laboratory related tasks Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Primary Location Belgium-Antwerp-Beerse- Organization Janssen Pharmaceutica N.V. (7555) Job Function R&D Requisition ID 2105974220W