Sterile Manufacturing Operations Leader

About the Company

Founded in 2012, today, Immacule Lifesciences has become a renowned name in the pharmaceutical industry. At Immacule, our dedicated team of scientists is here to provide you with customized services, supported by our extensive network of capabilities and resources. No matter where you are, as an end-to-end pharmaceutical service provider and partner we offer quality, speed and value by combining our technical competencies and cost-effective solutions.

We are backward integrated in pharmaceutical research and development and our focus ranges from the classification and development, to the commercialization of complex liquid (aqueous / non aqueous) and lyophilized injectables in vials and ampoules, with robust capabilities for terminal sterilization as well as aseptically filled injectables.

As a CDMO we are rapidly capturing the highly competitive sterile US market, in collaboration with our partners we have received 37 ANDAs approvals, have 18 ANDAs under review and a filing target of 50+ by 2025. Immacule is focusing on First to File 505(b)(2) submissions, NCEs & complex generics niche products scale-up, exhibit batches & commercial manufacturing support services to its global clients.

About the Role

Planning and execution of monthly manufacturing / packing plan and other manufacturing / packing activities. Responsible for production related tasks including production planning and process control and troubleshooting for achieving the planned periodic schedules.

Responsibilities

• To ensure effective compliance of quality management system as per cGMP and international regulatory requirement in production and ancillary areas.
• Responsible for implementation of systems, processes and procedures to facilitate smooth functioning of overall operations.
• To ensure the execution and maintenance of validated status of the injection facility.
• To ensure effectiveness of all standard operating procedures, batch document, master documents of production and compliance to documents.
• Assuring that the department is in compliance with cGMP / regulatory requirements.
• Co-ordination for new product transfers and thereafter support for process validations.
• Co-ordination with QA for self-inspection and compliance to the audit observations.
• Responsible for improvement in product yield and productivity.
• Proper utilization of man and machine and to ensure compliance for documents as per cGMP requirements.
• To prepare and review capex, user requirement specification etc.
• To prepare and review MIS report and other related documents of production department as per requirements.
• To ensure that initial and continuing training of production persons has been performed as per schedule.
• To confirm the training matrix, training reports of new and existing employees.
• To ensure scheduled validation of the equipment, calibration of devices and maintenance of equipment’s.
• Responsible for planning and implementation of preventative and predictive maintenance schedules.
• Overseeing the recruitment, performance of subordinates, mentoring / motivating them to improve their contribution levels.
• Responsible for man management and administrative functions and new Project management.
• Responsible for implementation of system, processes and procedures to facilitate smooth functioning of overall operations enhance operational efficiency and cost optimization.
• Market compliant investigation jointly with QA and other CFT’s.
• To comply and ensure the implementation of safety practices.
• To report that entire daily schedules and executions to the management.
• Responsible for self-Inspection as per schedule.
• Review and approval of QMS elements and process documents through ample logic and EDCS system.
• Review and approval of RM, PM, consumable and other dispensing activities through ERP system.

Qualifications

Experience