Janssen Research & Development, LLC., a Johnson and Johnson Company is hiring an 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 Scientist, Bioassay Methods Development will be responsible for development of assays such as cell-based bioassay and binding assays to be used as QC potency assays and 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. The individual will be responsible for method qualification, validation and transfer activities. Specific tasks would include:
Assay development, writing protocols, reports, and performing and coordinating testing to support manufacturing process development, process validations, and manufacturing investigations across functional groups
Accurate capture of data in a timely manner and entry into appropriate systems (e.g. LIMS), including maintenance of detailed records in compliance with applicable cGMP, safety, and environmental requirements as 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 as the successful candidate will support regulatory filings including INDs and BLAs
- Bachelor's degree in Biology, Chemistry, Pharmacology, Microbiology or other relevant scientific field, with at least 6 years of industry experience OR a Master's degree with at least 3 years of industry experience OR a PhD with relevant academic or industry experience is required
Experience with the development of cell-based bioassays and/or immunoassays is required
Immunoassay experience with ligand binding assays using ELISA and/or electrochemiluminescence assays, including drug levels assay is preferred
GMP/GLP experience is preferred
Experience with vaccines, antibody based therapeutics, or novel biologic therapeutics such as peptides, and microbiome therapeutics is preferred
Janssen Research & Development, LLC. (6084)Job Function