Analytical Development Chemist

hace 1 mes

Gijón, España Pci Pharma Services A tiempo completo

.Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI.Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.El Chemist I (Analista de Desarrollo Analítico I) es el encargado de ejecutar la parte experimental de los protocolos de validación y transferencia analítica, así como de la parte experimental del desarrollo de los métodos analíticos de acuerdo con la normativa aplicable en vigor (cGMP, FDA, etc), los procedimientos internos de trabajo de la compañía y las indicaciones establecidas por el técnico de Desarrollo Analítico.Descripción detallada de tareas y funciones a realizar por el Chemist I:Ejecución de ensayos menores (pH, osmolalidad, viscosidad, valoración KF, espectrofotometría, tamaño de partícula) y ensayos complejos (espectrofotometría, disolución in vitro, cromatografía líquida HPLC/UHPLC, cromatografía de gases).Realización de trabajo experimental en entorno GMP siguiendo los protocolos y método analíticos establecidos, así como la ejecución de verificaciones, validaciones y transferencias de métodos analíticos.Realización de trabajo tanto experimental como documental durante la fase de desarrollo de productos farmacéuticos participando en el desarrollo y optimización de métodos analíticos y caracterización de lotes.Registro documental del trabajo experimental realizado en todos los formatos requeridos según los procedimientos descritos por la compañía, así como la revisión de su correcta cumplimentación antes de su entrega al superior.Resolución de incidencias/eventos rutinarios con los equipos del laboratorio.En colaboración con el personal de Control de Calidad:Control de estándares, reactivos, columnas cromatográficas y material de laboratorio, así como gestión de muestras del Departamento de Desarrollo Analítico.Realizar el mantenimiento, calibración y verificación de la instrumentación del laboratorio.Participación en la gestión general, orden y limpieza del laboratorio de análisis.Colaborar en la formación del personal en prácticas.Reportar el trabajo realizado al personal técnico de Desarrollo Analítico.Participación en la detección y ejecuciones experimentales durante la investigación de eventos de calidad (incidencias/eventos, desviaciones, OOT, OOS).Elaboración de informes sencillos.Preferiblemente al menos 6 meses de experiencia en el sector y posición equivalente.Join us and be part of building the bridge between life changing therapies and patients.Let's talk future.Equal Employment Opportunity (EEO) Statement:- PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer

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