Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an 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.
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 host cell protein (HCP) assays and reagents to be used analytically during process characterization, to better understand HCP profile, removal and clearance for process development. Responsibilities may also include the development of potency binding and cell based assays to support a diverse portfolio. The individual will be responsible for method development, qualification, validation, transfer activities (as needed) as well as orthogonal method/tool use and development. Specific tasks will include:
- Reagent preparation, 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 and the successful candidate will support regulatory filings including INDs and BLAs
- 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 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 host cell protein method is required
- Host cell protein reagent development and host cell protein characterization are preferred
- Knowledge of orthogonal HCP method/tool/technology including application to reagent and process characterization is preferred
- Knowledge of mass spectrometry approaches/applications to HCP characterization is preferred
- Experience with various assay technologies (MSD, Threshold, Octet, Gyro, Biacore) is preferred
- Experience with ELISA method development across multiple technologies is preferred
- Experience in gel electrophoresis/immunoblot techniques, including 1D/2D, silver stain, western blot, WES or DIGE is preferred
- Experience with implementing automation platforms is preferred
Janssen Research & Development, LLC. (6084)Job Function