Director - CMC Leader, Large Molecule Biologics
Location:
Malvern , Pennsylvania
Posted:
April 02, 2017
Reference:
2088170214/1-en-us

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Director/Director, located in Malvern, PA or Spring House, PA.
 
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.  
 
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
 
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.  
 
The Associate Director/Director (depending on experience) within the Portfolio Management group will be responsible for leading 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.  The Associate Director/Director is also the CMC point of contact with the Compound Development Team(s) (CDT) and Value Stream Teams (VST).  Additional responsibilities include but are not limited to the following:
  • Help to identify opportunities for team or product development improvements across the PDMS organization. 
  • Support or lead teams in implementing initiatives to deliver organizational or process improvements
  • Demonstrate behaviors consistent with the current Leadership Imperatives
  • Mentoring and coaching CMC Team Members to improve their skills and contributions to the organization in collaboration with line management 
  • Focus on the compound development projects they lead which may span multiple Therapeutic Areas (TAs) and/or Janssen Supply Chain (JSC) and stages of development

 


Qualifications
  • 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 experience in pharmaceutical, biotechnology or a related industry is required
  • Large Molecule CMC experience is required
  • Understanding of early, late, and LCM development is preferred
  • Experience in setting development and regulatory strategies for products in development is required
  • Demonstrated capability to manage multiple projects
  • 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
  • Demonstrated ability to influence stakeholders without line authority

Primary Location
United States-Pennsylvania-Malvern
Other Locations
North America-United States-Pennsylvania-Spring House
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D
Requisition ID
2088170214

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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