ESPECIALISTA DISEÑO MÉTODOS ANALÍTICOS
Core
Design and implement analytical methodologies for quality control of R&D products and raw materials, including standardization, validation, and error investigation.
Role type
Analytical Methods Design Specialist (Pharmaceutical R&D)
Builds
Analytical procedures, validation protocols, and quality control metrics for new drug formulations and raw materials.
Domain
Pharmaceuticals / Analytical Chemistry
Required skills
Analytical method design, Method validation, Physicochemical analysis, Dissolution profiling, CAPA management, Regulatory response, Error investigation, Data reporting
Preferred skills
None stated
Technologies
SolTRAQs
Responsibilities
Standardize analytical methodologies for new products and reformulations based on pharmacopoeias; Elaborate analytical procedures for new products and raw materials; Perform physicochemical analysis of R&D materials; Review and validate analytical methods; Investigate out-of-specification results and obvious errors; Manage inventory of open investigations; Report metrics on error investigations and process indicators; Support responses to regulatory requirements.
Seniority
Mid-level Specialist (4+ years experience)