Head Of R&D
$65 por añoVirixene
*Desafío inicial:* desarrollar productos oncológicos genéricos para transferencia a manufactura en España y Argentina, con moléculas adicionales ya definidas para el pipeline.
*Responsabilidades principales*
* Liderar todas las operaciones de I+D, con responsabilidad total sobre el pipeline de oncológicos genéricos.
* Conducir proyectos iniciales a través de formulación, desarrollo analítico y escalado, hasta su transferencia a manufactura.
* Construir y documentar procesos robustos de formulación galénica, desarrollo analítico y escalado de laboratorio a escala industrial
* Establecer sistemas de calidad, procedimientos y documentación técnica para presentaciones ante FDA y EMA
* Trabajar directamente CEO y Operations Manager, en cada transferencia tecnológica
* Definir y construir el equipo técnico a medida
* Gestionar la documentación de IP en coordinación con asesoría legal
*Requisitos*
* Carrera en Farmacia, Ciencias Farmacéuticas, Química o equivalente (posgrado valorado)
* Mínimo 5 años en I+D farmacéutico, con experiencia en oncología o inyectables estériles
* Expertise en desarrollo galénico: diseño y adecuación de formulaciones, desarrollo analítico, escalado lab-to-industrial
* Experiencia en inyectables líquidos y/o liofilizados oncológicos (diferencial fuerte)
* Conocimiento de requisitos técnicos FDA/EMA para genéricos (ANDA o equivalente)
* Trayectoria comprobable llevando productos al ciclo completo de desarrollo hasta transferencia a manufactura
* Español e inglés profesional pleno, oral y escrito
* Radicado en Puerto Rico o con compromiso genuino de relocalizarse (no requiere residencia previa en la isla)
* Perfil emprendedor, autónomo, con capacidad de actuar con urgencia en entorno lean
*Qué ofrecemos*
* Mandato fundacional, construir una función de I+D desde cero, con plena autoridad técnica
* Beneficios fiscales Act 60 Capítulo 2 para profesionales que se relocalizan (proceso facilitado por la empresa)
* Salario base benchmarked al mercado farmacéutico de Puerto Rico, bono por performance y participación en el crecimiento
*Cómo aplicar* Postulaciones confidenciales: enviar CV y carta de presentación breve (español o inglés) a *******
Tipo de puesto: Tiempo completo, Indefinido
Sueldo: A partir de $65,****** al año
Lugar de trabajo: Empleo presencial
$180 000 por año
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