Pharmaceutical Development Lead Scientist I
Core
Technical lead for formulation design and development of oral solid dosage forms, leading clinical trial manufacturing activities.
Role type
Senior IC pharmaceutical development scientist (oral solid dosage forms)
Builds
Pharmaceutical formulations and clinical trial supplies
Domain
Life sciences / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
formulation design, experiment design, process development, regulatory compliance (GMP), technical documentation, team supervision, project management, data interpretation, instrumentation expertise, change impact assessment, cross-disciplinary data synthesis, deviation management, new technology assessment
Preferred skills
Master's or Doctorate degree in life/physical sciences, advanced data analysis, external presentation/publishing
Technologies
GMP, CMC filing packages, P100/PAPR respirators
Responsibilities
Develop and execute laboratory work plans, author and approve technical documents (protocols, SOPs, reports), review documents for regulatory compliance, train and mentor technical staff, supervise work assignments and performance, lead projects and manage customer interactions, drive efficiency improvement projects
Seniority
Senior, hands-on IC with supervisory responsibilities