Johnson & Johnson Careers
Senior Scientist, Bioassay Methods Development
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.
- A minimum of bachelor's degree in relevant scientific field, with at least 10 years of industry experience OR a Master's degree with at least 8 years of industry experience OR a PhD with 3-4 years of pharmaceutical or related industry experience in addition to a post-doctoral experience is required.
- Knowledge of drug development, particularly, related to potency and structure function characterization is required.
- Experience with method development in a variety of qPCR, cell-based bioassays, ELISA assays, and binding assays is required.
- Previous roles in method development of residual impurities such as qPCR for host cell DNA and residual protein A by ELISA are required.
- Previous leadership experience (matrix leadership, coaching, mentoring, leading projects) is required.
- Experience with therapeutic proteins, including antibodies, cell and gene therapies and/or vaccines is required.
- Direct people management and employee career development experience is preferred.
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
Janssen Research & Development, LLC (6084)