Manufacturing Supervisor

Manufacturing Supervisor

The Manufacturing (Filling) Supervisor oversees the production of biotechnology products for clinical and commercial use. This role involves working in cleanroom environments (ISO5ISO8), ensuring compliance with FDA cGMP and company SOPs, and maintaining high safety and quality standards.

Key Responsibilities :

• Follow work instructions and SOPs to meet production goals and maintain quality records.
• Perform and oversee activities such as :
• Material weighing and dispensing
• Equipment operation (autoclave, washers, fillers, mixers, pumps, etc.)
• Aseptic filling, filtration, and formulation of drug products
• Environmental and equipment cleaning (ISO5ISO8 areas)
• pH / conductivity checks, filter tests, and in-process sampling
• Complete all batch records, logbooks, and documentation accurately and on time.
• Ensure adherence to cGMP, SOPs, and regulatory standards.
• Handle hazardous materials safely and follow EHS guidelines.
• Participate in investigations, CAPA implementation, and validation activities.
• Supervise daily floor operations and guide staff to ensure efficient, compliant production.
• Train team members on SOPs, processes, and equipment.
• Conduct performance reviews, provide feedback, and support professional development.
• Communicate effectively with cross-functional teams and management.
• Identify and implement process improvements to increase efficiency and reduce waste.
• Support technology transfer from Process Development to Manufacturing.
• Review and update SOPs and manufacturing documents as needed.

Qualifications :

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!