Biotecnologia jobs in Spain

Job Title : Deputy Manufacturing Manager

About the Job :

The Deputy Manufacturing Manager is responsible for overseeing and managing aseptic manufacturing operations within a cleanroom environment. This role ensures compliance with cGMP regulations, leads process improvements, and provides strong leadership to a team of supervisors and operators. The Deputy Manufacturing Manager will directly oversee 4 to 6 direct reports and support a manufacturing division of approximately 120 personnel involved in the production of mammalian or microbial-based pharmaceutical or biologic products.

Key Responsibilities :

• Oversee and manage all aspects of aseptic manufacturing, including sterile filling, lyophilization (if applicable), capping, and inspection processes.
• Ensure strict adherence to aseptic techniques, environmental monitoring, and gowning requirements to maintain sterility assurance.
• Provide leadership and guidance to a team of 4 to 6 direct reports, fostering professional growth and ensuring alignment with operational goals.
• Support and oversee a broader manufacturing division of approximately 120 personnel, ensuring operational efficiency and compliance.
• Collaborate with maintenance, engineering, and quality teams to troubleshoot equipment issues and ensure minimal downtime.
• Drive continuous process improvements, optimizing manufacturing efficiencies while maintaining compliance with FDA, EMA, cGMP, and other regulatory requirements.
• Participate in regulatory audits and inspections, ensuring documentation accuracy and process validation compliance.
• Maintain and approve manufacturing documentation, including SOPs, batch records, deviations, CAPAs, and change controls.
• Lead investigations into process deviations and implement corrective and preventive actions (CAPAs) to ensure ongoing compliance and operational excellence.
• Foster a culture of safety, compliance, and continuous improvement across the manufacturing team.

Requirements :

• Minimum of 5+ years of experience in aseptic manufacturing, fill-finish operations, or sterile processing within the pharmaceutical or biotech industry.
• Strong understanding of cGMP, FDA, EMA, and other regulatory requirements related to sterile manufacturing.
• Proven leadership and team management experience, with a history of successfully leading and mentoring teams.
• Technical expertise in aseptic techniques, cleanroom environments, and validation processes.
• Experience managing a team of 4 to 6 direct reports , with oversight of a larger manufacturing workforce.
• Background in mammalian or microbial-based biologics manufacturing is preferred.
• Excellent problem-solving skills and ability to drive continuous improvement initiatives.
• Strong communication skills and ability to collaborate across departments.