Analytical Project Senior Scientist Pharmaceutical Development
Core
Develop analytical methods, strategies, and control plans for oral solid dosage forms and inhaled products from early development through commercialization.
Role type
Senior IC analytical project scientist (pharmaceutical development)
Builds
Robust analytical methods, control strategies, and regulatory submission-ready documentation for new medicines
Domain
Pharmaceutical development (oral solids and inhaled products)
Required skills
HPLC/UPLC, LC–MS, dissolution, aerosol characterization, method validation, CMC authoring, stability evaluation, GxP compliance, data integrity, cross-functional collaboration, technical supervision
Preferred skills
Six Sigma, multivariate experimental design (DoE), Bayesian optimization, chemometrics, solid-state characterization (XRPD, DSC, TGA), clinical manufacture support, team leadership
Technologies
HPLC/UPLC, LC–MS, impactor analysis, ELN/CDS, JMP/Minitab, Python/R
Responsibilities
Design, develop, validate, and transfer analytical methods; lead drug product characterization and stability programs; conduct root cause analyses and data integrity assessments; author CMC content for regulatory submissions; develop analytical control strategies aligned with ICH guidelines; mentor colleagues and drive science/technology initiatives
Seniority
Senior, hands-on IC with mentorship responsibilities
