Director, Analytical Development
Core
Leads a team of scientists to define end-to-end analytical development strategies for small molecule portfolios from candidate nomination through commercial approval.
Role type
Director, Analytical Development (People Management & Technical Leadership)
Builds
End-to-end analytical control strategies, regulatory submissions, and stability programs for small molecule drug products.
Domain
Pharmaceutical/Biotech, Small Molecule Development, Analytical Chemistry
Required skills
Small molecule analytical development, ICH guidelines (Q1, Q2, Q3, Q6A, Q14, M4, M7), cGMP, regulatory submissions, cross-functional leadership, team management, stability strategy, method development (HPLC/UPLC, GC, dissolution, etc.), pre-approval inspections, portfolio prioritization
Preferred skills
Experience with complex dosage forms (API, fixed-dose combinations, modified release, sterile injectables), LIMS/ELN and digital lab initiatives, PAT and modeling/simulation
Technologies
HPLC/UPLC, GC, dissolution, KF, spectroscopy, particle size, LIMS, ELN
Responsibilities
Lead and mentor a team of scientists; partner with Research, Regulatory, Process Chemistry, Formulation, Quality, and Manufacturing; drive development of analytical methodologies; guide technical transfer to internal QC and external partners; direct stability strategy and GMP programs; champion QbD and data integrity; serve on governance committees; author regulatory submissions; represent the team in health authority interactions; manage departmental budget and resources.
Seniority
Director, strategic leadership with hands-on technical oversight
