|CCL 19.05.09 Scientist, Biologics Drug Product Development|
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To: jobs at ccl.net
Date: Thu May 9 15:53:08 2019
Subject: 19.05.09 Scientist, Biologics Drug Product Development
Scientist, Biologics Drug Product Development(Job Number: 1072190411) Description: Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies is recruiting for a Scientist, Biologics Drug Product Development to be located in Malvern, PA. Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion, Janssen Research & Development, LLC is proud to be an equal opportunity employer. The successful candidate will work in the large molecule Drug Product Development (DPD) department. This role requires qualified candidate with expertise in computational biophysics and data analytics in biologics development. The candidate will support biologics formulation development activities and build machine learning and AI algorithms to analyze large amount of high throughput analytical data to build predictive capability. In addition, the candidate will have an opportunity to independently develop, design and perform biologics formulation development and characterization in support of formulation, process and fill-finish activities for vaccines and other biologic/cell therapy drug products. Responsibilities: - 50% Computational Biophysics, Modeling and advanced data analytics; and 50% Formulation Support - Design and execute experimental and computational studies to understand how antibodies interact with their environment for stability, processing, and administration. - Design computational models to predict protein-protein and protein-excipient interactions. - Build algorithms for machine learning of formulation data sets and generate statistical models with predictive ability - Support experimental design though advanced DOEs and statistical data analysis. - Correlate predicted protein behaviors/interactions to real time experimental outputs and stability. - Design and execute formulation development experiments for monoclonal antibodies and other biologic drug candidates (including vaccines, gene therapy), including rational formulation design/selection plus characterization studies relevant to the stage of development. Studies include, but are not limited to, biophysical characterization, stability, composition selection and robustness and development of administration protocols. - Contribute to documents for regulatory filings (ANDA, NDA, ANDS) and internal company use. - Lead or participate in cross-functional teams at project-related meetings, lead or facilitate technical discussions and successfully resolve problems with suppliers, methods, project issues and deviations. Qualifications: - Recent graduate with PhD in Pharmaceutical Sciences, Chemical Engineering, Computational Data Sciences or related scientific discipline, having 0-1 years of experience is required - Experience in computational biophysics, modeling and advanced data analytics to support large molecule drug product development is required - Ability to use, build, and optimize computational models to predict protein-protein and protein-excipient interactions is required - Ability to evaluate existing and newer computational models and softwares to support early and late biologics drug product development is required - Strong understanding and knowledge of protein stability and biophysical techniques for characterization is required - Strong understanding and knowledge of protein analytics and experience with a variety of standard protein analytical tools is required - Technical writing skills, including the ability to maintain high quality documentation and prepare reports, SOPs or other technical reports is required. - This role is based in Malvern, PA and may require up to 10% of domestic and international travel. Primary Location: North America-United States-Pennsylvania-Malvern Organization: Janssen Research & Development, LLC. (6084) Job Function: R&D Travel 0-10% Apply Here: http://www.Click2Apply.net/w2cpgpw63qx672x5 PI109893254
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