Regeneron
Tarrytown, NY
Shift: Full time
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 transfer documents, regulatory support documents, patents. Performing long-term planning for laboratory related personnel, supplies and equipment. This role may be for you if you: Have strong initiative and aim to complete challenging tasks and learn new technologies. Are capable of multi-tasking, working both independently and within a team environment. Have excellent interpersonal, verbal and written communication skills. Can think critically and demonstrate problem-solving skills. This role requires a Ph.D. or Master’s in organic chemistry or a related field. At least 7-8 years of industrial experience post-PhD or a MS w/120 years, or BS with 15 years in active pharmaceutical ingredient (API) process development is preferred. Experience with small-molecules in the bioconjugates space will be highly preferable. Hands on experience with organic molecule synthesis and characterization tools such as mass spectrometry, nuclear magnetic resonance (NMR), infrared (IR) spectroscopy, high-performance liquid chromatography (HPLC) etc. is preferred. Candidate must be well-versed with purification techniques such as crystallization, extraction, chromatography etc. Experience with solid-phase and liquid phase peptide synthesis is preferable. Proven experience in scaling-up synthetic small-molecule reactions and technology transfer to a GMP manufacturing facility is a plus. Candidate should be well-versed with International Council for Harmonization (ICH)/regulatory guidelines and their impact on process development of synthetic A typical day in the role of Staff Engineer might include: Designing and developing scalable, robust and controlled cGMP-ready processes for the chemical synthesis, purification, and isolation of oligonucleotides across early and late-stage process development. Ensuring a team-based evaluation of processes by working closely with several groups such as R D Chemistry, Formulations Development, Analytical Chemistry, Protein Biochemistry, CDMOs, and other key stakeholders to ensure integrated program success. Generating robust technology transfer documentation and supporting production with onsite presence during scale-up/GMP manufacturing activities. Partnering with the External Manufacturing group and other key partners at Regeneron’s Industrial Operations and Product Supply (IOPS) organization to vet CDMOs and successfully transfer processes with immediate, first-time success. Promote new technologies for process improvements, predictive process models, and novel at-line/in-line process analytical technologies to ensure robust processing. Reviewing and providing domain expertise for regulatory submissions. Authoring publications, reports, tech transfer documents, regulatory support documents, patents. Scientifically up-to-date on advances in process chemistry and related disciplines Requires up to 20% travel This role may be for you if you: Have strong initiative and aim to complete challenging tasks and learn new technologies. Are capable of multi-tasking, working bot