Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Senior Scientist, Bioanalysis and Pharmacokinetics (BAPK) to be located in Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
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.
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PDM is a critical part of the Discovery Sciences (DS) organization in Janssen R&D, and is committed to the delivery of key ADME (absorption, distribution, metabolism, and extraction), pharmacodynamics, and developability information needed for the generation of drug candidate in all five Janssen Therapeutic Area (TA) discovery teams. This mission requires deep scientific expertise in a number of disciplines including bioanalysis, drug metabolism, pharmacokinetics, and chemistry with an ability to work collaboratively with internal and external partners. The Bioanalysis and Pharmacokinetics (BAPK) group within PDM is responsible for a diverse range of activities including in-house bioanalytical and pharmacokinetic support for discovery and development studies, the monitoring of out-soured bioanalytical activities, and toxicokinetic/pharmacokinetic analysis. We are currently seeking an outstanding individual to join our team as Senior Scientist in the BAPK group. This position will be based in Spring House, PA.
The candidate will be a senior member of BAPK group within PDM. This candidate will play leadership role within PDM and global Bioanalytical by proactively interacting with discovery, TA, tox and clinical teams.
The internal work will focus on quantitation of drug candidates and biomarkers in complex biological matrices to support drug discovery and development. The candidate is expected to develop, validate, and implement key bioanalytical assays for small, large, and conjugate molecules, as well as biomarkers. The candidate is expected to bring in novel sample preparation and LC-MS technologies, including, but not limited to, immuno-affinity sample preparation, novel approaches for protein binding studies, tissue and intracellular bioanalysis, analysis of peptides, proteins, and conjugates. The candidate will also be expected to provide expertise advice to other JNJ groups on challenging bioanalytical issues and solutions. The candidate is expected to show a strong ability to work collaboratively with internal and external partners. The candidate will play a supporting role in enhancing the overall analytical capability of PDM organization and to represent Janssen for external scientific community.
This candidate will be one of the BAN scientists (Bioanalytical contact person for a given program) at US East Coast and supports projects globally via CROs and internal resources. This candidate will coordinate bioanalytical strategies and implementation plans in conjunction project teams. The candidate will ensure quality work at CROs by actively providing guidance, budgetary and timeline oversight as well as scientific/quality auditing. The candidate will ensure compliance of data integrity and will prepares or assist in the preparation of technical reports, manuscripts, scientific presentations and other documents that record data or results.
Overall, this candidate is expected to play a key role in strengthening the bioanalytical method development capabilities for both small and large molecule pipeline, and enhancing the bioanalysis innovation and issue-driven resolution for all programs as well as to ensure outsourced bioanalytical work is conducted appropriately.
• A Ph.D., with 5 years’ industrial bioanalysis experience or a Master’s Degree with 10 years of industrial bioanalysis experiences, with a degree in chemistry, biochemistry, biomedical sciences, or a related field.
• Extensive knowledge and hands-on experience of liquid chromatography and mass spectrometry (LC-MS) is required.
• Hands-on experience with analysis of both small and large molecules in complex biological matrices such as plasma, serum, and tissue is required.
• Hands-on experience with bioanalytical sample preparation skills, such as solid phase extraction, liquid-liquid extraction, immuno-affinity enrichment is required.
• Knowledge and experience with bioanalysis method development and assay establishment is required.
• Understanding of regulatory guidance for bioanalysis practice is required.
• Strong working experiences of monitoring Bioanalytical studies (GLP and clinical) is required.
• Strong communication with project teams and collaborators is required.
• Track record of scientific publications and presentations is required.
• Experience with bioanalysis of protein-drug conjugates or similar disciplines is preferred.
• Experience with ligand binding assays and cell-based assays is preferred.
• Understanding of drug ADME, pharmacokinetics, and protein chemistry is preferred.
• Experiences of biomarker research is preferred.