Johnson & Johnson Careers
Senior Associate Scientist, Residual Impurity Assay Development
Requisition ID: 4194190115
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Scientist, located in Malvern, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
The Senior Associate Scientist, Bioassay Methods Development will be responsible for development of residual impurity assays and reagents including host cell protein (HCP) assays to be used analytically during process characterization, to better understand residual impurity 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 candidate will have strong interpersonal skills, be ambitious to collaborate and succeed in a high performing team. Specific tasks will include:
- Responsibility for evaluation of new technologies, method development, qualification, validation and transfer activities as well as orthogonal method/tool use and development.
- Assay development, reagent preparation, writing protocols, reports, and performing and coordinating testing to support analytical development, manufacturing process development, process validations, and manufacturing investigations across functional groups.
- Writing analytical sections of regulatory submissions and support regulatory filings including INDs and BLAs.
- Providing technical support with development and QC laboratories and 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.
- Accurate, contemporaneous capture of data and entry into appropriate systems (e.g. LIMS), including maintenance of detailed records in compliance with applicable cGMP, safety, and environmental requirements. The successful candidate will ensure data integrity, protocol compliance, maintain laboratory notebooks and prepare written protocols and reports in a GMP compliant manner.
- Bachelor's degree in Biology, Chemistry or other relevant scientific field, with at least 4 years of industry experience OR a Master's degree in Biology, Chemistry or other relevant scientific field with at least 2 years of industry experience is required
- Strong experience with ELISA method development across multiple technologies as implemented for therapeutic proteins including antibodies, vaccines and viral vectors is required
- Experience with method robustness, DoE, method design and familiarity with assay validation parameters is preferred
- Experience with host cell protein method, reagent development and characterization is preferred
- Experience with implementing automation platforms is preferred
- Knowledge of orthogonal HCP method/tool/technology including application to reagent and process characterization is desired
- Experience with various assay technologies (ELISA, MSD, Threshold, Octet, Gyro, Biacore) is desired
- Experience in gel electrophoresis/immunoblot techniques, including 1D/2D, silver stain, western blot, WES or DIGE is desired
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Pennsylvania-Malvern-200 Great Valley Parkway
Janssen Research & Development, LLC. (6084)