Production Manager

Noord-Brabant Medical Device Permanent 06.02.2019

The role entails a broad range of duties and the specific areas of focus will be dependent on the skills and experience of the person holding the role.

The role entails a broad range of duties and the specific areas of focus will be dependent on the skills and experience of the person holding the role.

The basic responsibility is to ensure that cell therapy products are manufactured according to quality guidelines, regulatory requirements and trial needs.

The GMP Production Manager will work closely together with the Chief Operating Officer, Quality Control, Quality Assurance and the Development department. 

 

Job Responsibilities

  • Plan and organise cell production and reaching the GMP production target;
  • Manage the team in executing production process in dedicated manufacturing area; 
  • Interact with development manager on required improvements to the production process; 
  • Analyse results, write reports and provide management information like batch related data, production plan, production yield and critical process parameters; 
  • Review and revise manufacturing procedures, standard operating procedures, work instructions and worksheets; and 
  • Plan and execute installation qualification and operational qualification of equipment including supervision of functioning and maintenance.Managing development projects;

 

Education, skills and experience

The Production Manager will have:

  • MSc, BSc in biotechnology, bioprocessing, biology or other related fields. PhDs with relevant experience are also invited to apply;
  • Experience in Good Manufacturing Practices, preferably in managing GMP cell production;
  • Over 5 years experience in cell culture of mammalian cells and in flow cytometry; 
  • Interest and experience in laboratory devices; Organisational skills; 
  •  More than 3 years experience in leading a motivated team.

 

Conditions of employment:

  • After a successful trial period a permanent contract is extended.
  • Competitive salary, after your first year your salary will be adjusted accordingly with your performance and dedication; 
  • Pension premium contribution; 
  • Travel allowance or public transport reimbursement.
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