Director of GMP Analytical, Pharmaceutical Analytical Sciences
Core
Lead a team of scientists to support GMP analytical activities including method validation, clinical release, and stability testing for small molecule drug substance and drug product.
Role type
Director of GMP Analytical Sciences
Builds
Clinical drug substance and drug product for oral solid dosage forms and sterile liquids
Domain
Pharmaceutical / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, cGMP knowledge, ICH guidelines, FDA guidelines, liquid chromatography, spectroscopy, titration, dissolution, project management, root cause analysis, corrective and preventative actions, budget management, talent recruiting, employee development, cross-functional leadership
Preferred skills
Process Analytical Technology (PAT), Regulatory Submissions, Risk Assessment, Biologics License Application (BLA)
Technologies
Liquid chromatography, Spectroscopy, Titration, Dissolution
Responsibilities
Ensure cGMP compliance and operational excellence in laboratories, maintain inspection readiness, lead method validation and stability testing, review and approve GMP data and reports, serve as analytical lead during compliance audits, drive process improvements, recruit and develop employees
Seniority
Director, strategic leadership & team management
