Microbial Control Global Manager

At mAbxience, a company specialized in the development and manufacturing of biosimilar medicines, we are hiring a Microbial Control Global Manager.

General Responsibility

The Microbial Control Global Manager is responsible for developing, implementing, and overseeing contamination control strategies in a biopharmaceutical manufacturing environment across the different sites and proactively ensures compliance with regulatory requirements, industry standards, and company policies to maintain a proactive microbial control strategy to guarantee the safety of the products. This role will serve to execute continuous improvement activities in the microbial area in all sites guaranteeing the harmonization of practices across the different sites. She / he will serve to train and educate in best aseptic practices.

Specific Responsibilities

• Continuously improve a comprehensive Contamination Control Strategy (CCS) to minimize microbial, particulate, and chemical contamination risks in.
• Harmonize microbial practices across different sites of mAbxience
• Provide subject matter expertise during deviation investigations and corrective actions.
• Create best practices documents globally to assure harmonization and communication between sites
• Communicate proactively improvement opportunities for both sites and make sure implementation and training to the staff
• Lead contamination control risk assessments and establish proactive mitigation measures.
• Ensure compliance with regulatory guidelines (FDA, EMA, GMP, ICH, ISO) and internal quality standards.
• Oversee environmental monitoring programs, including air, water, and surface contamination testing.
• Manage contamination control training programs for production and quality personnel.
• Collaborate with cross-functional teams to design and maintain cleanroom and controlled environmental standards.
• Investigate contamination-related deviations, identify root causes, and implement corrective and preventive actions (CAPAs).
• Optimize cleaning and disinfection procedures to ensure a high standard of facility hygiene.
• Stay updated with industry trends, new technologies, and regulatory updates related to contamination control.
• Provide subject matter expertise during audits and regulatory inspections.

Qualifications & Requirements:

• Bachelor's or master's degree in microbiology, Biotechnology, Biochemistry, or a related field.
• Minimum of 5 years of experience in contamination control, environmental monitoring, or quality assurance in the biopharmaceutical industry.
• Strong knowledge of GMP regulations and industry best practices in microbial control.
• Experience with risk assessment tools, CAPA processes, and validation protocols.
• Excellent problem-solving, analytical, and communication skills.
• Ability to lead cross-functional teams and train personnel effectively.
• Strong attention to detail and commitment to maintaining high-quality standards.

Preferred Qualifications:

• Experience in aseptic processing and sterile manufacturing environments.
• Experience in Biologics manufacturing GMP.
• Certification in contamination control or microbiological quality assurance.
• Familiarity with digital monitoring and data analytics tools for contamination tracking.

Working Conditions:

• Proactive and continuous improvement mindset.
• Operational Excellence knowledge is a plus
• Interaction with various departments, including Quality, Manufacturing, Engineering, and Regulatory teams on all sites of mAbxience.
• Travel (25%) may be required for improvement opportunities, audits, inspections, and training sessions.
• Location can be either Argentina, León or Madrid.

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.