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Associate Scientist, Bioassay Method Development
Requisition ID: 3450171106
Janssen Research & Development, LLC., a Johnson and Johnson Company is hiring an Associate Scientist, to be 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 visithttp://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.
Within Janssen Research & Development, the Product Development & Manufacturing Science (PDMS) organization is responsible for the development, clinical supply, marketed product support, and life cycle management of chemical and biologic pharmaceutical products. Within PDMS, the Analytical Development group supports method development and validation, release and stability testing, structural characterization, and preparation of regulatory filings. Bioassays are specifically required for biologic pharmaceutical products.
The Associate Scientist will assist in designing and performing new bioassays, immunoassays, nucleic acid assays, and gel electrophoresis and will support method qualification, validation activities and prepares protocols and reports. Performs testing to support manufacturing process development, process validations and manufacturing investigations. Additional responsibilities include but are not limited to:
- Ensure accurate capture of data in a timely manner and entry into appropriate systems (e.g., LIMS)
- Maintain detailed records in compliance with applicable cGMP, safety and environmental requirements
- Ensure data integrity and protocol compliance
- Write, review and modify SOP's, protocols and other laboratory documents
- Bachelor's degree in Biology, Chemistry or other relevant scientific field, with at least 2 years of research experience OR a Master's degree with at least 1 year of research experience OR a PhD with relevant research experience is required
- Experience in performing bioassays is required
- Experience in performing immunoassays and/or nucleic acid assays is required
- Experience in method development is preferred
- Experience with various assay technologies (ELISA, MSD, High Content Imaging, Flow Cytometry, 1D/2D, DIGE, western blot) is preferred
- cGMP experience is preferred
Janssen Research & Development, LLC. (6084)