Johnson & Johnson Careers

Senior Scientist, CAR-T Process Development

Spring House, Pennsylvania
R&D


Job Description

Requisition ID: 8523181130

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Scientist, located in 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.
 
The Senior Scientist will be responsible for process development of CAR-t products within the BioTherapeutics API department based in Spring House, PA. He/she will be part of the team responsible for developing manufacturing process for autologous and allogeneic cell therapy products.  The candidate will direct activities and develop strategy to develop manufacturing process in a cross-functional matrix team, including the design of experiments, execution of the planned experiments, optimization of the process steps, and scale-up to the target process scale for early and late stage products.  Additional responsibilities include but are not limited to the following: 
  • Lead a team responsible for the design and execution of development studies to identify and determine appropriate ranges of (critical) process parameters for the drug substance process.  
  • Participate or take a lead role in a cross-functional team to transfer technology to cGMP manufacturing partners.  
  • Write and review protocols, technical reports, regulatory documents and memos to summarize experiments and investigations. 
  • Collaborate with internal and external partners to evaluated and implement
  • Interact with internal cross-functional team members including QA, Regulatory, and Operations 
  • Work effectively in a team environment as well as contributing individually as well as managing the team to meet project timeline and objectives.  
  • Preparation of CMC sections for regulatory submissions (IND, BLA) in collaboration with other departments. 
  • Other duties will be assigned, as necessary

Qualifications
  • A Ph.D. in Chemical Engineering or Biological Sciences or Biochemistry with at least 4 years of relevant experience OR MS in Chemical Engineering or Biological Sciences or Biochemistry with at least 8 years of relevant experience OR a BS in Chemical Engineering or Biological Sciences or Biochemistry with at least 12 years of relevant experience is required
  • Knowledge in T-cell biology and immunology are preferred
  • Prior industry experience is required
  • Strong technical knowledge in the process development and tech transfer of autologous cell therapy products to cGMP manufacturing facilities is required
  • Previous experience in leading cross-functional matrix project teams is required
  • Previous experience in late stage process development and regulatory filing in the biopharmaceutical industry are required
  • Experience maintaining written records of work in the form of laboratory notebooks (paper or electronic) is required
  • The ability to report data, present findings to management is required
  • Experience with team-based collaborations or direct management of staff is required
  • Occasional domestic or international travel will be required

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
8523181130