R
Not Specified Permanent

Tarrytown, New York · USA job

Principal Scientist, Formulation Development (DPDT)

Regeneron Pharmaceuticals

Tarrytown, New York

Job description

Overview

In this role you will lead drug product development across modalities from candidate selection through clinical development and commercialization. You work as a subject-matter expert within DPDT, applying biochemical, biophysical, and microbiology principles to design and execute experiments and processes. You'll shape development programs, collaborate across teams, and drive technology transfer and regulatory-aligned documentation. The position offers high-impact work in a fast-growing science-driven organization, with on-site leadership in Tarrytown, NY.

Compensation / Benefits
  • annual bonuses or incentive plans
  • equity awards
  • 401(k) company match
  • health and wellness programs
  • insurance benefits (medical, dental, vision, life and disability)
  • paid time off
Responsibilities
  • Lead complex drug product development programs across modalities (protein/antibody, siRNA, peptides, bioconjugates, AAV)
  • Design and execute formulation, analytical, and process development experiments
  • Apply QbD concepts and regulatory guidelines to development activities
  • Mentor and develop junior scientists; lead cross-functional collaboration
  • Perform data analysis and study design using JMP or equivalent
  • Prepare protocols, technical reports, and regulatory documents; contribute to publications and patents
  • Maintain rigorous lab records and ensure data integrity; oversee lab instrument maintenance
  • Lead or participate in technology transfer and process scale-up
  • Present data to internal and external audiences; support regulatory communications
  • Support safety, EHS compliance, and environmental requirements
Key requirements
  • PhD with 4+ years of relevant industry experience or BS/MS with at least 10 years, or PhD with at least 5 years in biopharma
  • Experience with bioconjugates, especially antibody-oligonucleotide formulation development (preferred)
  • Strong independence in decision-making and project leadership
  • Experience with formulation development, analytical methods, and process development
  • Proven ability to lead cross-functional teams and mentor others
  • Familiarity with regulatory guidelines and QbD approaches
  • Proficiency in data analysis software (e.g., JMP)
  • Excellent communication skills for diverse audiences
  • Experience with ELN, SDMS, LIMS, EDMS (documentation systems)
  • On-site work requirement in Tarrytown, NY
  • communication
  • leadership/mentorship
  • collaboration
  • biochemistry
  • biophysics
  • microbiology

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