Scientist, Bioassay Method Development

Job description

Job Description

Requisition ID: 0758181220

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a 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 atwww.janssen.com and follow us Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Within Janssen Research & Development, the Biotherapeutic Development organization is responsible for the development, clinical supply, marketed product support, and technical life cycle management of biologic pharmaceutical products, in partnership with the Janssen Supply Group. Within BioTD, the Analytical Development group supports method development and validation, release and stability testing, technical transfer to manufacturing sites, 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 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 also to be used as QC potency assays. Additional responsiblilities include:

·  Responsiblity for evaluation of new technologies method development, qualification, validation and transfer activities and represent Bioassay on Analytical sub teams
·  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
·  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
·  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 and maintain laboratory notebooks and prepare written protocols and reports in a GMP compliant manner

Desired profile

Qualifications

·  Bachelor's degree in Biology, Chemistry, Pharmacology, Molecular Biology, Immunology 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 method development in a variety of cell-based bioassays and/or binding assays is required
·  Preferred skills would include method robustness, DoE, method design and familiarity with assay validation parameters
·  Experience with therapeutic proteins, including antibodies, cell and gene therapy and/or vaccines is preferred
·  Experience in performing bioassays, binding assays, and/or immunochemical techniques, such as flow cytometry and immunoassays is required

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.

Primary Location
United States-Pennsylvania-Malvern-200 Great Valley Parkway
Organization
Janssen Research & Development, LLC. (6084)
Job Function
R&D
Requisition ID
0758181220