Johnson & Johnson Careers

Senior Scientist, Bioassay Methods Development

Malvern, Pennsylvania
R&D


Job Description

Requisition ID: 2135190812

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.


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. 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.


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 Senior Scientist, Bioassay Methods Development will be responsible for leading a small team in the development of assays such as cell-based bioassays, qPCR methods to detect residual DNA, binding assays to be used in support of structure-function as well as biological characterization studies to better understand mechanism of action for protein therapeutics, and the ideal candidate should possess a strong understanding of residual impurity methods for the detection of host cell DNA and protein A. These methods will support molecules in clinical development as well as commercial products and may be used as QC potency assays or release assays. Responsibilities include:

  • Development, qualification/validation and transfer of assays to QC labs.
  • Biological characterization in support of IND and BLA filings including, structure function and comparability studies.
  • Support regulatory filings including INDs and BLAs.
  • Assume responsibility for a staff of approximately 2-4 employees (direct reports).
  • Represent the department on cross-functional and external teams and act as a technical expert on bioassays, immunoassays, and/or residual impurity assays.


Qualifications

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-
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
2135190812