Analytical Project Lead
hace 5 meses
Buscamos Analytical Project Lead para cubrir baja maternal.
Su misión principal será, coordinar las actividades analíticas necesarias durante todo el ciclo de vida de productos farmacéuticos oftálmicos (pomadas, geles y colirios) desde el desarrollo, transferencia hasta la
producción comercial.
Principales responsabilidades:
Coordinar las actividades analíticas necesarias durante todo el ciclo de vida de productosfarmacéuticos oftálmicos (pomadas, geles y colirios) desde el desarrollo, transferencia hasta la produción comercial) en la planta de El Masnou Desarrollo y optimización de métodos analíticos de excipientes, APIs y producto terminado o Testing de muestras del desarrollo de formulaciones y productos entrantes (excipientes, API), lotes piloto y clínicos Validación, verificación y transferencia de métodos analíticos Estudios de estabilidad Optimización de los métodos implementados para la producción comercial Soporte al área de control de calidad en la resolución de problemas Durante la ejecución de un proyecto, es el responsable de la supervisión científica de las actividades que se lleven a cabo en el laboratorio y del equipo asignado al proyecto Responsable de la edición de los documentos de soporte necesarios para llevar a cabo las actividades (SOPs, protocolos, informes, especificaciones, etc) Revisar resultados analíticos derivados de la ejecución de las actividades de desarrollo analítico asignadas y gestionar las posibles Desviaciones Analíticas ocurridas. Define la planificación del proyecto(s) asignado(s) y es el responsable de asegurar que se cumplen en el tiempo definido Informar sobre posibles desviaciones en tiempo o costes de los proyectos asignados. Da soporte a las áreas de QC y QA en las investigaciones analíticas derivadas de desviaciones,reclamaciones o procedimientos de registro. Revisa los procedimientos y procesos establecidos dentro del departamento de análisis, proponiendo optimizaciones y contribuyendo al proceso de mejora continua. Interviene en el proceso de evaluación de nuevos proyectos de productos farmacéuticos de clientes externos con respecto a los esfuerzos analíticos, la viabilidad y el potencial de optimización. Evaluación de los métodos analíticos de los productos existentes en cuanto al potencial de optimización de los mismos Estrecha colaboración con el departamento de desarrollo de formulaciones, QA, QC, business development y otras funciones de la planta, así como con sus homólogos de la empresa cliente. Representa a la compañía en cuestiones científicas y técnicas relacionadas con el desarrollo analítico en las reuniones llevadas a cabo con los clientes Responsable de la transferencia del know-how entre el cliente y Siegfried (y viceversa) así como entre plantas de la compañía. Responsable de transferir la información relacionada con el proyecto asignado a todas las partes interesadas Informar de manera periódica al Analytical Development Head sobre el progreso del proyecto (s) asignados, los desafíos, los bottleneck, etc.Your profile
Educación : BSc, MSc or equivalent in Chemistry, Pharmacy, Pharmaceutical Technology or equivalent I diomas : Idioma del país e Inglés Avanzado Experiencia : Mínimo 3 años de experiencia en laboratorios de Desarrollo Analítico,Control de Calidad o similares. Experiencia en gestión de proyectos.
Amplio conocimiento de técnicas analíticas. Conocimientos de cGMP
Working at Siegfried
Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs.Who we are
In the Midst of People’s Lives – Across the GlobeThe Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model. The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production. We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products. What we do in El MasnouBulk manufacturing and packaging of sterile ophthalmic products including eye drops, eye ointments, otic / nasal sprays-
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