Janssen Pharmaceutical Research and Development, a member of Johnson & Johnson's Family of Companies, is recruiting for a Scientist - Cell and Gene Therapy Formulation to join our Drug Product Development(DPD) 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.
Janssen PRD develops innovative biomedicines. The world leader in monoclonal antibody production and technology, Janssen has brought critical biologic therapies to patients suffering from debilitating cancer and immune disorders.
The Scientist - Cell and Gene Therapy Formulation 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. The ideal candidate must have a proven track record of developing innovative solutions to problems in cell and gene therapy cryopreservation formulations. 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.
The successful 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 process
Master's degree in Biomedical Sciences, Biomedical Engineering Chemical Engineering, Pharmaceutical Sciences or closely related discipline with ten or more years of 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 is 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.
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)