Gmp Manufacturing Manager

JR Spain; Bilbao; Presencial; EUR 50.000 - 80.000; Jornada completa

Descripción de la vacante

Una organización de desarrollo y fabricación de terapias avanzadas en Bilbao busca un GMP Manufacturing Manager. Las responsabilidades incluyen liderar un equipo, asegurar el cumplimiento de normativas y gestionar las operaciones de fabricación a escala comercial. Se requiere un título universitario y experiencia sustancial en entornos GMP farmacéuticos, así como habilidades en liderazgo y comunicación. Se ofrece la oportunidad de construir una organización de alto rendimiento en un mercado en crecimiento.

Servicios

Oportunidad de unirse a una tecnología única y disruptiva

Participar en la construcción de una organización de alto rendimiento

Formación

• 8-10 años de experiencia en un entorno GMP farmacéutico/biotecnológico.
• 3+ años supervisando un equipo en un entorno de cGMP bio/farmacéutico.
• Fluidez en inglés y español.

Responsabilidades

• Dirigir y desarrollar un equipo de profesionales cualificados.
• Gestionar las instalaciones de fabricación GMP de acuerdo con las normas de calidad.
• Iniciar y optimizar las actividades de fabricación GMP.

Conocimientos

Liderazgo

Comunicación efectiva

Resolución de problemas

Educación

University degree

Herramientas

Chromatography (ÄKTA)

Filtración estéril

Descripción del empleo

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GMP Manufacturing Manager

A new state-of-the-art, Advanced Therapies Contract Development and Manufacturing Organization (CDMO), located in Bilbao, Spain, is looking for a GMP Manufacturing Manager.

Key duties / Responsibilities

• Manage, develop, and lead a team of skilled professionals.
• Manage the GMP manufacturing facility to meet established delivery schedules and the company's stringent quality standards.
• Support a culture of operational excellence where teamwork and active problem solving lead to continuous improvement throughout the organization.
• Ensure that team activities, equipment, facilities, and personnel are operated and maintained in a state of compliance with appropriate requirements.
• Defend his/her area of responsibility in regulatory or customer audits.

Minimum Qualifications

• University degree.
• 8-10 years of experience in a pharmaceutical/biotechnology GMP environment.
• 3+ years of experience supervising a team in a bio/pharmaceutical cGMP operating environment.
• Expertise in chromatography (ÄKTA process systems), tangential flow filtration or sterile filtration.
• Experience in commercial scale cGMP operations, deviation handling, GMP change control and validation.
• Familiarity with advanced therapy products is a plus.
• Experience in defending and managing audits, including those conducted by EMA and FDA, as well as customer-initiated audits.
• Flexible enough to adapt to a growing organization and diverse client needs.
• Proven ability to innovate and drive continuous improvement.
• Ability to build and lead high performing teams and be a strong team player.
• Strong organizational skills.
• Ability to solve practical problems and deal with a variety of variables.
• Good communication skills.
• Fluent in English and Spanish.

We offer

• Join a new CDMO with a unique, disruptive technology in a high-growth market.
• Help build a high-performance organization.
• Initiate and optimize GMP manufacturing activities.