Director, CMC Leader in Large Molecule Biologics

작업 내용

Janssen Research & Development, L.L.C., a division of Johnson & Johnson’s Family of Companies is recruiting for a Director, CMC Leader in Large Molecule Biologics that can be located in Spring House, PA, Malvern, PA, Beerse, Belgium, Switzerland, or Leiden, Netherlands. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies. Responsibilities: Within the Portfolio Management group, you will lead multiple CMC Teams spanning from pre-NME through post-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 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. You will be the CMC point of contact with the Compound Development Team(s) (CDT) and Value Stream Teams (VST). You will see opportunities for team or product development improvements across the PDMS organization. They may also support or lead teams in implementing initiatives to deliver organizational or process improvements. You will demonstrate behaviors consistent with the current Leadership Imperatives and will be mentoring and coaching CMC Team Members to improve their skills and contributions to the organization in collaboration with line management. Your main focus is on development projects which may span multiple Therapeutic Areas (TAs) and/or Janssen Supply Chain (JSC) and stages of development. Working in a multi-disciplinary, complex and innovative environment, with evidence of delivering results in this setting, including: In-depth experience and technical knowledge of the Large Molecule CMC development process, preferably including an understanding of early, late and LCM development. Qualifications Minimum of a Ph.D. with 10 years of proven experience in pharmaceutical, biotechnology or a related industry is required Large Molecule CMC experience is required Experience in setting development and regulatory strategies for products in development is required Excellent communication skills, both oral and written, as well as proven conflict management and negotiation skills Excellent interpersonal skills with the ability to adapt effectively to a constantly evolving organization issues, structures and dynamics Demonstrated capability to manage multiple projects 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 Influencing ability without line authority 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 United States-Pennsylvania-Malvern-200 Great Valley Parkway Other Locations Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Switzerland Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2105946528W