Sr Manager Gmp Operations

"Caring for the worldone person at a time”inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo **Sr Manager GMP Operations** Main responsibilities: Aim of the position: Leads and manages all organizational and manufacturing related activities within GMP Operations for ExPEC production to ensure that business objectives are met efficiently and effectively. Manages in-house manufacturing of cell banks, virus seeds, drug substances and drug products to meet the business needs for pre-clinical through commercial supplies. - Manages flow to ensure successful transformation of raw materials into products (cell banks, virus seeds, drug substances and drug products) for ExPEC production from early stage to commercial - Ensures that manufactured products are stored according to the appropriate documentation to obtain the required quality - Accountable for proper operating of all manufacturing process-related equipment. Qualification, maintenance, and validations of the process equipment are done appropriately - Pursue cost-effective manufacturing through continuous improvements, e.g. by eliminating non-value adding steps (focusing on e.g. first-time-right/zero-deviation manufacturing) - Makes sure training plans are aligned with areas in need of improvement. Reviews and approves standard operational and working practices - Ensures the approval of needed documents to release the manufactured batches within GMP Operations - Ensures effective transfer from Product development department of new products into manufacturing process - Maintains raw material, work-in-progress, and finished goods inventory levels relative to demand. - Assists in the development of manufacturing cost control reports, cost estimates, capacity planning, manpower and facility requirements. - Tracks key performance metrics. Develops, implements, and maintains quality control requirements and processes. - Communicates and enforces business objectives, policies, and procedures to the department. - Recommends revisions to standard operating procedures and observes employees to ensures compliance with business. - Manages the proper installation and routine maintenance of processing equipment. - Manages flow to ensure successful transformation of raw materials into products (cell banks, virus seeds, drug substances and drug products) for Lenti production from early stage to commercial - Ensures that manufactured products are stored according to the appropriate documentation to obtain the required quality - Accountable for proper operating of all manufacturing process-related equipment. Qualification, maintenance, and validations of the process equipment are done appropriately - Pursue cost-effective manufacturing through continuous improvements, e.g. by eliminating non-value adding steps (focusing on e.g. first-time-right/zero-deviation manufacturing) - Makes sure training plans are aligned with areas in need of improvement. Reviews and approves standard operational and working practices - Ensures the approval of needed documents to release the manufactured batches within GMP Operations - Ensures effective transfer from Product development department of new products into manufacturing process - Maintains raw material, work-in-progress, and finished goods inventory levels relative to demand. - Assists in the development of manufacturing cost control reports, cost estimates, capacity planning, manpower and facility requirements. - Tracks key performance metrics. Develops, implements, and maintains quality control requirements and processes. - Communicates and enforces business objectives, policies, and procedures to the department. - Recommends revisions to standard operating procedures and observes employees to ensures compliance with business. - Manages the proper installation and routine maintenance of processing equipment. - Definition and execution of departmental strategy in alignment with site strategy and stakeholders. - Monitoring and improving departmental performance - Preparation of departmental budget - Management of departmental supply/demand, including deployment of contractors - Line management of employees, creating an open, supportive, and healthy working environment which fosters personal development, and which allows a sustainable work/life balance. - Departmental communication and stakeholder management - Representation of department in governance and management structures, governance bodies and project teams as required. - Ensuring activities are executed in compliance with applicable regulations as well as legal, q