Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Scientist, Formulation - Cell and Gene Therapy. The position will be 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.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Scientist, Formulation - Cell and Gene Therapy will play a key role in drug product development to support formulation, fill/finish process and cryopreservation development for early, mid, and late stage cell and gene therapy NMEs. The position will require hands-on laboratory work and project responsibilities. Responsibilities include development and optimization of drug product formulations, as well as execution of characterization plans and stability studies, with the goal of developing a better understanding and improving drug product stability.
candidate will develop strong relationships with Janssen Biotherapeutics Development
partner groups including but not limited to basic research and manufacturing
areas. In addition, the candidate will work with the CMC Dossier Support
group to provide technical support for regulatory submissions of NME and prior
approval supplements for new and existing drug products. The position
also requires designing and optimizing various cryopreservation formulation
screening, controlled rate freezing process and well versed in cell and gene
therapy characterization parameters leading to commercial scale manufacturing
- Master's degree in Biomedical Sciences, Biomedical Engineering Chemical Engineering, Pharmaceutical Sciences or closely related discipline with 6-7 years experience OR a Ph.D. in Biomedical Sciences, Biomedical Engineering Chemical Engineering, Pharmaceutical Sciences or closely related discipline is required.
- Experience in formulation and fill/finish process development for cell and gene therapy and/or biological molecules is desired.
- Experience with cell and gene therapy drug product manufacturing, formulation and cryopreservation process is preferred.
- In-depth understanding of cell biology and molecular biology, immunology and virology are required.
- Experience with quantitative real time PCR, flow cytometry, potency and functional assays is desirable.
- Working knowledge of HPLC, MALDI, cSDS-PAGE , DSC, CD, and Fluorescence spectroscopy is a plus.
- Working knowledge of GMP requirements is also preferred.
- Experience implementing and maintaining high quality standards for all aspects of work conducted including adherence to regulatory GLP/GMP, departmental, and safety guidelines is preferred.
- Experience mentoring others in a matrix environment is preferred.
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC (6084)