Johnson & Johnson Careers
Scientist, Bioassay Methods Development
Requisition ID: 1654190506
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.
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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Scientist, Bioassay Methods Development will be responsible for the development of assays such as qPCR, cell-based bioassays, and binding assays to be used in support of structure-function and biological characterization studies to better understand mechanism of action for recombinant Adeno-associated Virus (rAAV) gene therapies and protein therapeutics. These methods will support molecules in clinical development as well as commercial products and may be used as QC potency assays. You will be responsible for method development, qualification/validation and transfer activities.
Additional responsibilities include, but are not limited to:
• 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 fashion and entry into appropriate systems (e.g. LIMS), 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.
• Maintain laboratory notebooks and prepare written protocols and reports in a GMP compliant manner.
• Writing analytical sections of regulatory submissions and will support regulatory filings including INDs and BLAs.
• Bachelor's degree in Biology, Chemistry, Pharmacology. Microbiology or other relevant scientific field, with at least 7 years of industry experience OR a Master's degree with at least 5 years of industry experience OR a PhD with relevant drug development experience in an academic or industry setting is required.
• Knowledge of drug development, particularly, related to potency and structure function characterization is required.
• Drug development experience using AAV gene therapy is required.
• Experience with method development in a variety of qPCR, cell-based bioassays and binding assays is required.
• Experience in immunochemical techniques, including flow cytometry and immunoassays is highly preferred.
• Experience in immunology and/or metabolic disorders such as obesity is preferred.
• Experience with novel biologic therapeutics such as peptides, conjugates and/or antibody-based therapeutics, is preferred.
• Previous leadership experience (coaching, mentoring, leading projects) is preferred.
• This role is based in Malvern, PA and may require up to 10% of travel.
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)