Principal Scientist, Formulation Development (DPDT)

Regeneron Pharmaceuticals•Tarrytown, GA

4d•$128,600 - $210,000•Onsite

About The Position

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/program(s), 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.

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 minimum of 10 years, or a PhD with a minimum of 5 years, of relevant industry experience

Nice To Haves

Industry experience with bioconjugates, particularly antibody-oligonucleotide formulation development, is preferred

Responsibilities

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