Sr Manager Gmp Operations - Bern, Schweiz - Johnson & Johnson

Johnson & Johnson

Geprüftes Unternehmen

Bern, Schweiz

vor 3 Wochen

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

"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 processrelated equipment. Qualification, maintenance, and validations of the process equipment are done appropriately
Pursue costeffective manufacturing through continuous improvements, e.g. by eliminating nonvalue adding steps (focusing on e.g. firsttimeright/zerodeviation 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, workinprogress, 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 processrelated equipment. Qualification, maintenance, and validations of the process equipment are done appropriately
Pursue costeffective manufacturing through continuous improvements, e.g. by eliminating nonvalue adding steps (focusing on e.g. firsttimeright/zerodeviation 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, workinprogress, 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