SrStaffEngineer,SyntheticandBioconjugationScale-UpTechnologies(PMPD)

Regeneron's Preclinical Manufacturing & Process Development group (PMPD), located in Tarrytown NY, is seeking a hardworking and dynamic **Sr** **Staff Engineer** for its Synthetic and Bioconjugation Scale-up Technologies (SBST) group. In this exciting new role, you will provide scientific leadership and support for synthetic oligonucleotide process development using the principles of Quality by Design (QbD), process scale-up, and technology transfer of manufacturing-related workflows at Contract Development and Manufacturing Organizations (CDMOs) to ensure timely and reliable entrance to the clinic through product commercialization. **A Typical Day in the Role of Sr Staff Engineer might include:** * Designing and developing scalable, robust and controlled GMP-ready processes for chemical synthesis of small-molecules. This includes purification development and establishing supporting analytical characterization techniques. * Proactively complying to lab safety and environmental safety expectations of both Regeneron and regulatory bodies such as Food and Drug Administration (FDA), Department of Transportation (DoT), etc. * Ensuring a team-based evaluation of processes by working closely with several groups such as R&D chemistry, Formulations Development, Analytical Chemistry, and Protein Biochemistry to ensure integrated program success. * Generating robust technology transfer documentation and supporting production with onsite presence during scale-up/GMP manufacturing activities. * Partnering with External Manufacturing group and other key partners at Regeneron’s IOPS organization to vet CDMO’s and successfully transfer processes with immediate, first-time success. * Developing new technologies for process improvements and predictive process models, and pioneering novel at-line/in-line process analytical technologies to ensure robust processing. * Reviewing and providing domain expertise for all regulatory submissions. * Authoring publications, reports, tech transfe