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.
• 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.
• 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.