Johnson & Johnson Careers

Associate Director, BioTherapeutics Drug Product Development

Spring House, Pennsylvania
R&D


Job Description

Requisition ID: 1840190412

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Associate Director, located in Spring House, PA.

 

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.

 

In this position you are responsible for scientific guidance of formulation development for new products and line extensions of therapeutic proteins or other biologics, with technical accountability for cell therapies. The cell therapy team develops, designs and performs formulation and process development work to support formulation development, cryopreservation and cell banking activities of CAR-T cell therapy products, including production of cell banks, virus seeds and other biological products (e.g., viral and bacterial antigens, tissues, and proteinaceous drug products) in a GxP environment for use in vaccine and protein production, diagnostic testing and/or quality control.  However, you will provide scientific product and process expertise to a broad range of products from early to late development through life-cycle management and marketed products. You will be a people manager responsible for strategic direction and external alliances to strengthen and drive innovation in drug product development. Major duties and responsibilities include:
  • Sets the strategic and scientific directions of the assigned projects in close collaboration with the project teams and stakeholders.
  • Provides scientific guidance to new NME declarations, late phase development projects and scientific investigations.
  • Acts as subject matter expert for scientific and strategic aspects of formulation development for biologics development.
  • Partners with cross functional groups to ensure processes are consistent to accepted Janssen standards and are in compliance with the submitted CMC dossiers and general cGMP regulations.
  • Drives team strategy towards innovation meeting development, supply chain and patient unmet needs.
  • Responsible for establishing technical product framework for a range of CAR-T programs, including novel approaches to cell therapy.

Qualifications
  • Ph.D. degree with at least 10 years of experience in the biopharmaceutical industry spanning a range of biotherapeutic modalities
  • Cell culture/cell therapy or upstream development experience highly desirable
  • Proven track record of process and product development excellence, creativity and problem solving is required
  • Ability to collaborate with cross functional teams and budgetary responsibilities are a must
  • Strong knowledge and experience of fill/finish technology transfer is required
  • Demonstrated competency and experience in third party relationships and health authority submissions/audits
  • Ability to conduct multiple scientific projects in an organized and productive manner
  • High sense of responsibility regarding scientific and professional activities
  • Track record of publications/patents, people management and talent development
  • Excellent oral and written language skills in English
  • This position is based in Spring House, PA with approximately 20% travel.

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.


Primary Location
United States-Pennsylvania-Spring House-1400�McKean�Road
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D
Requisition ID
1840190412