Sr. Scientist, Pharmaceutical Development
Core
Senior technical leader driving pharmaceutical development from early discovery through commercialization, focusing on process design, scale-up, and manufacturing readiness for neurological, psychiatric, endocrine, and immunological disorders.
Role type
Senior IC pharmaceutical development scientist (CMC)
Builds
Robust, phase-appropriate formulations and manufacturing processes for drug products
Domain
Biopharmaceuticals / Pharmaceutical Development / CMC
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> product features (drug products)
Required skills
cGMP compliance, process design and optimization, scale-up and validation, technology transfer, analytical method development and validation, stability program management, regulatory submission authorship (IND/NDA), CRO/CDMO management, Quality by Design (QbD), statistical analysis, root cause analysis, cross-functional leadership
Preferred skills
Postdoc experience, strategic planning, budget management, portfolio-level decision-making, emerging technology assessment
Technologies
DoE, CPV, CPI, characterization instrumentation, data analysis tools
Responsibilities
Lead CMC project teams across the product lifecycle; design and scale manufacturing processes using QbD; oversee CRO/CDMO partnerships and technical transfer; act as technical lead during manufacturing campaigns; author and review regulatory submissions; mentor team members
Seniority
Senior, hands-on IC with strategic leadership