- Entry level
- No Education
- Salary to negotiate
- Spring House
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Principal 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 Principal Scientist will lead a team 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, Legal, Operations and Discovery.
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
A Ph.D. in Chemical Engineering or Biological Sciences or Biochemistry with at least 10 years of relevant experience OR MS in Chemical Engineering or Biological Sciences or Biochemistry with at least 12 years of relevant experience OR a BS in Chemical Engineering or Biological Sciences or Biochemistry with at least 15 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.
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC. (6084)
About the company
If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.