Principal Scientist, Formulation Development (DPDT)
Core
Lead drug product development activities from candidate selection through commercialization for protein, siRNA, peptides, bioconjugates, and AAV modalities.
Role type
Principal Scientist, Formulation Development
Builds
Drug products and novel delivery technologies for serious diseases
Domain
Biopharma / Protein therapeutics / Formulation Science
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Formulation development, Bioconjugate expertise, Analytical development, Process development, Technology transfer, QbD application, JMP statistical software, Risk-based decision making, Technical mentoring, Regulatory document authoring, Lab instrumentation management
Preferred skills
Antibody-oligonucleotide formulation development
Technologies
JMP, ELN, SDMS, LIMS, EDMS
Responsibilities
Design rigorous experiments for formulation and process development, Act as subject matter expert and apply QbD approaches, Plan and lead complex long-term projects, Mentor junior scientists and train direct reports, Author regulatory documents, protocols, and patents, Maintain accurate laboratory records and ensure data integrity, Engage in lab and instrument maintenance
Seniority
Principal, hands-on IC with mentorship