Principal Scientist, Formulation Development; DPDT

Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Principal Scientist to join our Drug Product Development & Technology (DPDT) team.

You’ll lead drug product development activities from candidate selection and pre-clinical development through clinical development and commercialization for a variety of drug modalities, which may include protein (antibody), siRNA, peptides, bioconjugates (antibody-oligo or antibody-drug), and AAV, across a variety of drug and delivery presentations including liquid and lyophilized DP and novel drug delivery technologies.

You’ll work independently to lead your project/programs, applying biochemical, biophysical, and/or microbiology principles to execute both simple and complex experiments and processes.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:
Shift Requirements:
Full-time, standard business hours, with flexibility to support before- and after-hours executive meetings, town halls, and corporate events

Location:

On-site in Tarrytown, NY

• Works independently and applies technical knowledge to design rigorous experiments that may include formulation, analytical, and process development and technology transfer
• Acts as a resource and is recognized as a subject matter expert (SME) within their field; applies QbD approaches to drug product development and stays knowledgeable about current regulatory guidelines
• Applies scientific and statistical knowledge of software packages (JMP or equivalent) to support study design and data analysis
• Independently makes decisions of moderate complexity in a timely manner, including with limited information, understanding how decisions impact target priorities and cross-functional teams; uses a risk-based approach to make complex decisions and demonstrates judgment on when feedback from management is needed
• Receives information and direction from leadership, and is responsible for planning and leading complex, long-term projects
• Collaborates effectively as an SME and within cross-functional teams to support timely execution of deliverables
• Proactively researches and implements new approaches toward problem-solving and/or process optimization for product development and new technology evaluations; capable of diving into novel fields and developing expertise needed in new areas or technologies
• Brings managerial experience with demonstrated success developing direct reports; trains junior scientists in technical skills and mentors junior colleagues
• Communicates effectively with varied audiences internally and externally, clearly explaining technical data that support recommendations or strategic direction
• Participates in team meetings and prepares data presentations and documents, including publications and patents
• Generates internal reports and authors external documents, which may include protocols, technical reports, risk assessments, regulatory documents, and patents
• Maintains complete and accurate laboratory record documentation and complies with all data integrity procedures and system requirements, including ELN, SDMS, LIMS, and EDMS
• Engages in lab and instrument maintenance activities, acting as instrument SME or team lead, and may champion implementation of new instrumentation and analytical techniques
• Complies with environmental, health, and safety requirements

A PhD in Pharmaceutical Sciences, Biochemistry, Chemistry, Biophysics, Biomedical or Chemical Engineering, or a related field with 4+ years of relevant industry experience in the biopharma space; or a BS/MS with a…