Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for a Research Scientist - Process Sciences, to be located in Raritan, NJ.
Janssen Research & Development, L.L.C. is a fully integrated biopharmaceutical and biotechnology company. As a world leader in the field of biomedicines, Janssen strives to develop innovative treatments to improve the health of people worldwide. At the forefront of monoclonal antibody technology and manufacturing, Janssen Research & Development manufactures products including REMICADE® (infliximab), STELARA™ (ustekinumab) and SIMPONI™ (golimumab) for the treatment of various immunological diseases.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Research Scientist - Process Sciences will work as a member of a team responsible for the development and scale-up of mammalian cell culture-based manufacturing processes. This work encompasses a wide range of technologies, including but not limited to, cell culture vessel evaluation, media and supplement optimization, separation systems, and fill/finish operations.
Accordingly, this scientist will identify novel technologies which may be incorporated into manufacturing processes, develop novel procedures and unit operations, ensure the scalability of novel and existing unit operations, relate the characterization of process intermediates and product to process performance, and troubleshoot issues of consistency, quality and scale.
In this context, the research scientist must be able to work with a high level of autonomy to design, execute, and interpret laboratory studies to develop and troubleshoot clinical and commercial biologics manufacturing process steps. In addition, he/she will be expected to support root-cause analyses and Corrective And Preventative Actions (CAPAs). Key skills include managing timelines and participating in decisions related to equipment selections and the process, including changes, improvements and deviations.
This scientist will also work as part of a team which performs technology transfers of manufacturing processes to cGMP manufacturing facilities. In this context they will author and review technical reports and memos to summarize experiments and investigations and provide scientific and technical input to support regulatory submissions and agency inquiries. As the programs progress, the successful candidate will also be called upon to perform other duties as necessary.
A Masters Degree in Biological Sciences, Biochemistry or Chemical Engineering with 6+ years of bioindustrial experience or the equivalent OR a Ph.D. in Biological Sciences, Biochemistry, or Chemical Engineering with 4+ years of bioindustrial experience or the equivalent is required. A strong background in process development and technology transfer is required. Experience in the field of cell therapy is preferred. Development and scale-up mammalian cell culture-based manufacturing process experience is required. Experience with fill/finish operations is required. Experience supporting root-cause analyses and Corrective And Preventative Actions (CAPAs) is highly desirable. Prior biologics cGMP experience is preferred. A high level of computer literacy with experience in factorial design methodologies, including multivariate statistics is preferred. Prior exposure to Six Sigma and Lean improvement methods such as DMAIC is also highly desirable. Strong written and inter-personal communication skills and function well in a matrix management organizational environment are required. This position is located in Raritan, NJ.
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North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)
Johnson & Johnson Family of Companies - 22 months ago