Sr Manager Gmp Operations
vor 6 Monaten
"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
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