Principal Scientist, Pharmaceutical Development
Core
Senior technical leader in Pharmaceutical Development guiding CMC projects from early discovery through commercialization for parenteral drug products.
Role type
Principal Scientist, Pharmaceutical Development
Builds
Parenteral drug products (monoclonal antibodies, peptides, conjugates) for clinical and commercial use
Domain
Biopharmaceuticals / Parenteral Drug Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process development and scale-up, Quality by Design (QbD), experimental design (DoE), technology transfer, regulatory submission authoring, CRO/CDMO management, analytical method validation, characterization instrumentation, lifecycle management
Preferred skills
Combination product design, postdoc experience
Technologies
cGMP, ICH guidelines, FDA/EMA regulations, DoE, QbD
Responsibilities
Lead CMC strategy and execution across product lifecycle, oversee CRO/CDMO partnerships and technical transfer, act as technical lead during manufacturing campaigns, author and review regulatory submissions (IND, NDA), mentor team members, drive continuous process verification and improvement
Seniority
Principal, hands-on IC with strategic oversight
