Director Manufacturing Operation

vor 2 Monaten

Cuxhaven, Deutschland Vibalogics GmbH Vollzeit
Director Manufacturing Operation (m/f/d) View job here Director Manufacturing Operation (m/f/d)
  • Vollzeit
  • Zeppelinstraße 2, 27472 Cuxhaven, Deutschland
  • Mit Leitungsfunktion
  • 11.09.24

ReciBioPharm, with its Vibalogics GmbH site in Cuxhaven, is a globally recognized partner for the development of the latest virotherapies and vector-based vaccines. We develop manufacturing processes and produce oncolytic viruses for the sustainable fight against cancer, gene shuttles for the treatment of genetic diseases and innovative viral vector vaccines to protect against fatal infectious diseases.

ReciBioPharm is part of Recipharm, a leading contract development and manufacturing organization for the pharmaceutical industry. It employs over 5200 people worldwide and offers manufacturing services for pharmaceuticals in various dosage forms. Our portfolio also includes the production of clinical trial material and active pharmaceutical ingredients as well as pharmaceutical product development.

As a contract manufacturer with project business, we work according to the principles of Good Manufacturing Practice (GMP). We serve customers in Europe, North America and Asia, thereby supporting the development of highly innovative medicines. Our day-to-day work is extremely varied and therefore offers a wide range of development opportunities. We would now like to strengthen our team with a highly motivated colleague (m/f/d).

Director Manufacturing Operation (m/f/d)

Goal of this position is the management of the production according to all relevant legal and international requirements like AMG, GMP and required standards of the Group of Recipharm. 

Responsibilities:

  •          Manage Production Department according to all applicable legal requirements such as AMWHV, AMG, GMP and required Standard Operating Procedures.
  •          Ensure HSE rules and standards are fulfilled according to all applicable regulations and company standards.
  •          Create and implement a site-wide Safety Culture.
  •          Execute production plans and deliver on defined goals for Production.
  •          Ensure an annual investment plan for Production and a list of critical equipment.
  •          Responsible for the qualification and maintenance of the department, premises and equipment.
  •          Ensure the appropriate validations.
  •          Make sure that the required initial and continuing training of department personnel is carried out and adapted according to needs.
  •         Responsible for complete and timely documentation according to the requirements.
  •         Ensure that the production records are evaluated and signed by himself or an authorized person.
  •         Approve instructions related to production and ensure their strict implementation.
  •         Drive quality an efficiency improvement in Production.

      Profile:

  •          Very good knowledge of cGMP, AMG, AMV and GDP as well as Hygienic aspects.
  •         Minimum of 7 years of experience in Pharma Production, preferably sterile.
  •         Technical know how of the process and equipment used in Pharma Production.
  •         Good knowledge of IT-Systems and IT-Tools.
  •      Social skills and learning capabilities.
  •      Good leadership skills.
  •      Excellent communication skills in English and/or German complete the profile.

Our offer:

  • Permanent full-time position, 30 days vacation
  • An extremely varied working day
  • A friendly working atmosphere in an international environment
  • Attractive renumeration package
  • Company fitness program, capital-forming benefits, bike leasing option
  • A location with maritime flair and support for a possible relocation to Cuxhaven
  • A mentoring program for induction and much more
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