Gmp Manufacturing Manager

hace 2 semanas

Bilbao, España LIM GLOBAL A tiempo completo

Bilbao

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 one or more of the following areas: 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 regulatory agencies such as 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.

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