Production Director

百明信康生物技术（杭州）有限公司 Worgpharma; Madrid; Presencial; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

A leading biotech company in Madrid is seeking a Production Director to oversee manufacturing operations for allergy diagnostic and therapeutic products. The role requires strong leadership, compliance with regulatory standards, and a focus on quality and efficiency. Candidates should have extensive experience in biotech manufacturing and a relevant degree. The company offers a competitive compensation package and a collaborative work environment focused on innovation.

Servicios

Competitive compensation package

Professional development opportunities

Dynamic work environment

Formación

• Minimum of 8–10 years in biotech or pharmaceutical manufacturing, with at least 5 years in a leadership role.
• Strong knowledge of EU GMP, ISO 13485, and relevant quality frameworks.

Responsabilidades

• Lead day-to-day production operations ensuring safety, quality, and cost targets are met.
• Drive capacity planning and resource allocation to meet business demand.
• Ensure compliance with regulatory requirements and manage production quality.

Conocimientos

Leadership

Collaboration

Quality Management

Educación

Degree in Biotechnology

Degree in Pharmacy

Degree in Industrial Engineering

Degree in Chemical Engineering

Herramientas

ERP

MES

LIMS

Descripción del empleo

We are seeking an experienced Production Director to lead the manufacturing operations of our allergy diagnostic and therapeutic product lines at our facility in Madrid. Reporting to the Head of Manufacturing , this role is responsible for ensuring the reliable, compliant and efficient production of high-quality biological products for both diagnosis and treatment of allergic diseases.

Key Responsibilities :

• Lead day-to-day production operations across diagnostic and therapeutic product lines to ensure safety, quality, delivery and cost targets are met.
• Complete all production tasks assigned by the factory department on time and with good quality.
• Oversees the implementation of lean manufacturing and continuous strategies.
• Drives capacity planning, resource allocation and production scaling to meet business demand.
• Ensure compliance with regulatory requirements
• Ensure that all production activities of our factory are carried out in accordance with the production management documents, and take responsibility for the entire production process and GMP management of the factory to ensure that the production quality meets the standards, and take responsibility for the quality of the produced products .
• Monitors and improve key manufacturing KPIs : OOE, yield, scrap rates, down times and lead times.
• Coordinate the sourcing, supply and control of surpluses in collaboration with the warehouse, production and commercial area.
• Actively participate in meetings in their field of action, implementing the relevant actions and transmitting the objectives to the team and all personnel related to the mission.
• Carry out analytical reports for strategic decision making, establishing continuous improvements and reporting to the Head of Manufacturing.
• Manage the budget of the production area, ensuring compliance and optimization of resources.
• Supervise compliance with customer delivery deadlines.
• Develop and execute manufacturing plans in coordination with Planning and Supply Chain functions to meet commercial, clinical, and inventory targets.
• Supervise and develop a multidisciplinary production team, fostering a culture of safety, quality, and continuous improvement.
• Collaborate closely with Engineering on equipment maintenance, qualification, and technical support to ensure operational reliability.
• Drive efficiency and scalability through implementation of Lean Manufacturing principles, KPI monitoring, and process optimization.
• Fosters a culture of safety, accountability and operational excellence.
• Oversee preparation and maintenance of production-related documentation in collaboration with Documentation Support to ensure data integrity and regulatory readiness.
• Support technology transfers, product launches, and scale-up activities in close coordination with R&D, Quality, and Regulatory teams.
• Lead or support investigations of deviations and non-conformances; ensure timely implementation of CAPAs.
• Participate in audits and inspections by health authorities (e.g., AEMPS, EMA) and ensure readiness at all times leading the resolution of any identified gaps

Requirements :

• Degree in Biotechnology, Pharmacy, Industrial Engineering, Chemical Engineering, or a related field.
• Minimum of 8–10 years of experience in biotech or pharmaceutical manufacturing, with at least 5 years in a leadership role .
• Experience in manufacturing biological products and / or diagnostic kits , ideally in the field of allergy immunotherapy .
• Strong knowledge of EU GMP , ISO 13485 , and relevant quality and regulatory frameworks for combination products.
• Demonstrated leadership skills with the ability to motivate teams and manage cross-functional collaboration.
• Fluent in Spanish and proficient in English (spoken and written).

Preferred Qualifications :

• Experience in allergen extraction, sterile or aseptic operations, and small-batch production environments.
• Familiarity with digital production systems (ERP, MES, LIMS).
• Lean Six Sigma certification or demonstrated experience in operational excellence initiatives.
• Background in tech transfer and supporting clinical to commercial scale transitions.

What We Offer :

• A leadership role in a purpose-driven biotech company improving the lives of allergy patients worldwide.
• A dynamic and collaborative work environment with strong emphasis on innovation and quality.
• Competitive compensation package and professional development opportunities.