Principal Scientist, Formulation Development (DPDT)

Job Summary

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.

About the role

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.

Responsibilities

• Lead drug product development activities from candidate selection and pre-clinical development through clinical development and commercialization for a variety of drug modalities.
• Apply biochemical, biophysical, and/or microbiology principles to execute both simple and complex experiments and processes.
• Work independently to lead your project/program(s).
• Act as a resource and is recognized as a subject matter expert (SME) within their field; apply QbD approaches to drug product development and stay knowledgeable about current regulatory guidelines.
• Apply scientific and statistical knowledge of software packages (JMP or equivalent) to support study design and data analysis.
• Make decisions of moderate complexity in a timely manner, including with limited information, understanding how decisions impact target priorities and cross-functional teams; use a risk-based approach to make complex decisions and demonstrate judgment on when feedback from management is needed.
• Collaborate effectively as an SME and within cross-functional teams to support timely execution of deliverables.
• Proactively research and implement 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.
• Bring managerial experience with demonstrated success developing direct reports; train junior scientists in technical skills and mentor junior colleagues.
• Communicate effectively with varied audiences internally and externally, clearly explaining technical data that support recommendations or strategic direction.
• Generate internal reports and author external documents, which may include protocols, technical reports, risk assessments, regulatory documents, and patents.
• Maintain complete and accurate laboratory record documentation and comply with all data integrity procedures and system requirements, including ELN, SDMS, LIMS, and EDMS.
• Engage in lab and instrument maintenance activities, act as instrument SME or team lead, and may champion implementation of new instrumentation and analytical techniques.
• Comply with environmental, health, and safety requirements.

Requirements

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