SR.) MANAGER GMP OPERATIONS

Caring for the world… one 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.
.
by eliminating non-value adding steps (focusing on e.
.
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.
.
by eliminating non-value adding steps (focusing on e.
.
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, quality & EHS requirements.
§ Operations review and approval of GMP relevant documents – Departmental approval for TruVault § Deputy of Head of GMP Operations § Approver to release of manufacture batches within GMP operations Qualifications Your Profile.
§ At least bachelor or master’s degrees in life sciences GMP manufacturing management experience (6-8y § Lean/Continuous improvement mindset § Fluent in German and English § Able to handle stress § Analytical strong and able to handle complexity § Making use of Diversity, Equity & Inclusion § Able to lead, manage, and achieve goals through influence rather than power.
§ People developer § EHS mindset and experience with environment and safety concepts in pharma business § Achieves goals by building bridges between and across people, stakeholders, departments, and sites.
§ Clear and goal-oriented communication skills to all levels and layers within teams and the overall organization § Preferred Networker Benefits.
We offer a competitive salary and extensive benefits package.
The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance.
We offer career development opportunities for those who want to grow and be part of our organization.
We are Janssen! Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.