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Senior Associate Scientist, Bioassay Method Development
Requisition ID: 5570180309
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Senior Associate Scientist, located in Malvern, 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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Senior Associate Scientist, Bioassay Methods Development will assist in the development of cell-based bioassay and binding assays to be used in support of structure-function and biological characterization studies, to better understand mechanism of action for new molecular entities in clinical development and for commercial products and as QC potency assays. The individual will be responsible for evaluation of new technologies method development, qualification, validation and transfer activities. Additional responsibilities include but are not limited to:
Assay development, writing protocols, reports, and performing and coordinating testing to support analytical development, manufacturing process development, process validations, and manufacturing investigations across functional groups
Accurate capture of data in a timely manner, including maintenance of detailed records in compliance with applicable cGMP, safety, and environmental requirements is expected and the successful candidate will ensure data integrity and protocol compliance
Maintain laboratory notebooks and prepare written protocols and reports in a GMP compliant manner
Writing analytical sections of regulatory submissions is expected and the successful candidate will support regulatory filings including INDs and BLAs
Providing technical support with development and QC laboratories is expected and the successful candidate will also support Quality Assurance, Regulatory Affairs and Process Development groups for all phases of product development as well as ongoing support of analytical methods for marketed products
- Bachelor's degree in Biology, Chemistry, Pharmacology or other relevant scientific field, with at least 4 years of industry experience OR a Master's degree with at least 2 years of industry experience or with relevant academic experience is required
- Experience in performing bioassays and binding assays are required; immunochemical techniques, including flow cytometry and immunoassays are preferred
- Experience with method development in a variety of cell-based bioassays is required; Preferred skills would include method robustness, DoE, method design and familiarity with assay validation parameters
- Experience and knowledge of development of protein therapeutics in metabolic disorders is preferred
- Experience with developing and performing qPCR or other quantitative DNA methods is preferred
- Experience with various assay technologies (Droplet Digital PCR, MSD, Threshold) is preferred
- Experience with GxP compliance is preferred
- Experience with therapeutic proteins, including antibodies, cell and gene therapy and/or peptides is preferred
Janssen Research & Development, LLC. (6084)