R&D Technical Project Leadership

buscojobs España; Valladolid; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

Una empresa líder en medicina biosimilar busca un líder de proyectos técnicos en I+D para su sitio de fabricación en León, España. Este rol implica la coordinación de actividades técnicas y la mejora de procesos de producción, contribuyendo a la optimización y cumplimiento regulatorio. Se requiere un PhD en Bioquímica o Química, y fluidez en español e inglés.

Formación

• Experiencia relevante de más de 6 años en actividades de laboratorio con productos farmacéuticos biológicos.
• Habilidades en lectura y escritura de documentos técnicos.
• Capacidad para gestionar la calificación y el mantenimiento del laboratorio de I+D.

Responsabilidades

• Coordinar actividades relacionadas con los proyectos técnicos en producción.
• Planificar y organizar ensayos de producción.
• Asegurar el cumplimiento de las regulaciones en el laboratorio de I+D.

Conocimientos

Fluidez en español

Fluidez en inglés

Coordinación técnica

Optimización de procesos

Educación

PhD en Bioquímica / Química

Descripción del empleo

At mAbxience, a company specialized in the development and manufacturing of biosimilar medicines, we are hiring a R&D Technical Project Leadership for our Manufacturing Site in León (Spain).

General Responsibility

Responsible for coordinating technical project related activities across the different team (AD, FD, DSP, UPS, and CLD) of antibody and non-antibody protein biosimilar molecules production processes.

Specific Responsibilities

Planning, organizing and overseeing processes or production trials

Making improvements or modifications to current processes.

Technical coordination across the different units of the R & D department (PD / AD / FD).

Ensure technical activities performance according to the program plan.

Leads the performance and execution of troubleshooting studies.

Project specific patent review and support IP department.

Day to day technical support to manufacturing process.

Oversee testing procedures and fine-tuning the product or process in order to optimize performance.

Writing and reading technical papers, reports, reviews and specifications.

Lead and manage internal compliance of regulations in the R&D laboratory.

Lead and management assurance qualification, maintenance R&D laboratory equipment; as well as the documentation management of the R&D laboratory.

Coordination of a follow up of R&D investment Budget

Requirements and personal skills

Education : PhD in relevant Biochemistry / chemistry specialty.

Languages : Fluent Spanish and English, knowledge of other languages will be an asset.

Experience (years / area) : +1 (I), 3-6 (II) or +6 (III) years of relevant expertise in laboratory activities working with biologics pharmaceuticals and biotech environments.

Travels : Not required.

Mabxience is a company committed to equal opportunities, and therefore, all candidates will be considered without distinction of race, color, gender, age, sexual orientation, religion, origin, marital status, citizenship, or disability.