Production Supervisor

The ideal candidate will manage sterile manufacturing operations in a highly regulated pharmaceutical setting, ensuring full adherence to cGMP, safety, and quality requirements. This role demands solid expertise in aseptic processing and practical experience with biosimilar and oncology filling lines. The candidate will lead production teams, uphold operational efficiency, and champion continuous improvement across all sterile production processes.Key ResponsibilitiesSupervise day-to-day sterile production activities, ensuring adherence to approved batch records, SOPs, GMP, and safety protocols.Oversee aseptic filling operations for biosimilars and oncology products in compliance with regulatory and internal quality requirements.Ensure optimal performance of isolator-based filling systems, monitoring environmental conditions and sterility assurance measures.Manage operations involving prefilled syringes (PFS) and prefilled pens (PFP), ensuring accuracy, efficiency, and compliance throughout manufacturing.Coordinate with Maintenance, Quality Assurance, Engineering, and Planning to ensure equipment readiness and production continuity.Lead, train, and mentor production technicians and operators to ensure high skill levels and cGMP compliance.Allocate resources, assign tasks, and monitor team performance to achieve production targets.Foster a culture of safety, accountability, and continuous improvement.Enforce strict compliance with aseptic techniques, gowning procedures, and contamination control practices.Participate in deviation investigations, CAPA implementation, change controls, and root cause analyses.Review production documentation for accuracy, completeness, and compliance before submission.Support internal and external audits and prepare required documentation.Identify opportunities to enhance productivity, reduce waste, and improve process robustness.Support validation activities, including equipment qualification and process validation.Collaborate with cross-functional teams to introduce new products or technologies into sterile operations.QualificationsBachelor’s degree in PharmacyMinimum 8 years of experience in sterile pharmaceutical manufacturingProven hands-on experience with: Filling of biosimilars and oncology products Isolator technologies, Prefilled Syringes (PFS), Prefilled Pens (PFP)Strong understanding of aseptic techniques, contamination control, cleanroom operations, and cGMP regulations.Excellent leadership, communication, and problem-solving skills.Ability to work under pressure in a fast-paced, highly regulated environment.