Associate Director, CAR-T Process Development
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for aAssociate Director,located in Spring House, PA or Raritan, NJ.
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.
Associate Director 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 lead a highly technical team to design and develop manufacturing process for autologous and allogeneic cell therapy products. The candidate will interact with Oncology group to develop and drive the strategy to develop engineered T cell products in the pipeline. The candidate will direct activities to develop drug substance 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 responsibilies 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.
- Extensively collaborate with internal and external partners to evaluated and implement new process technologies to develop next generation processes.
- 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,Cell Biology or Immunology 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 immunologyare required
- Prior industry experience is required
- Strong technical knowledge in the process development of autologous cell therapy products and process development of virus-based products to engineering cells is required
- Previous experience in managing and mentoring process scientists is required
- Previous experience in late stage process development and regulatory filing in the biopharmaceutical industryare preferred
- Familiarity with and hands-on experience with analytical methods typically used in the manufacture and characterization of biological products is preferred
- 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-1400�McKean�Road
North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)
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