Job Properties
  • Job Type
    Full-time Position
  • Category
    Administration & Operations
  • Languages
    English
  • Experience Required
    Entry
  • Degree Required
    Bachelor
    • Province
      Groningen
    • Date Posted
      November 24,2021
    • JSS
    • VISA
    • MOCKINTERVIEW
    • IMG_6430
    • Career Consultation
    • COVERLETTER CHECK
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    Head of Operations

    Thermo Fisher Scientific Groningen is looking for an experienced leader in a complex and highly regulated environment. Are you the leader that has a track record in bringing teams to operational excellence?

    When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. You will have a real-world impact, and you’ll be supported in achieving your career goals.


    Purpose of the Job

    To plan, develop and execute clinical and commercial manufacturing processes in Operations Groningen, within corporate requirements and guidelines, in order to achieve financial, business and strategic objectives.


    Job and Position Context

    Thermo Fisher Groningen operates as a Contract Manufacturing Organization (CMO) for small to large Pharmaceutical customers. Thermo Fisher exclusively focuses on production of antibodies and other active pharma proteins using mammalian cell lines.

    The technologies that Thermo Fisher offers are industry standard to state of the art (including Single Use Technologies such as Single Use Bioreactors). For each new product a manufacturing process is to be developed and optimized. Annually, 5-10 new manufacturing processes are transferred into the Operations department.

    Production activities range from executing a totally new production run for the first time, to the routine production of commercial products. Due to the diversity of customers, and their associated products, the applicable processing steps are very diverse. Customers range from having products in the clinical stage of development to customers that have a commercial product. This requires different strategies to support customers from short time to the clinic to full commercial manufacturing in line with the required guidelines.

    The biopharmaceutical facility at the Groningen is a highly controlled environment that complies with rules and regulations which is essential for employee and patient safety and therefore the license to operate for the site.

    Leadership
    The job holder is responsible for the quality and quantity of the manufacturing processes. You wil have the responsibility for proper availability of personnel, equipment, facilities, systems & support, for proper execution of manufacturing.

    The job holder ideally has significant experience as a leader of change, gained in a highly regulated environment. Experience with leadership in bringing an organisation to operational excellence is highly valued.

    Collaboration
    The job holder is operating in a wide network within and outside Thermo Fisher and will closely collaborate within the local organisation, within the international Thermo Fisher network and with our clients.

    Quality and EH&S
    Responsible for acting according to EH&S, Quality and cGMP regulations. Production must be performed under safe conditions, while the health of the operators has to be guaranteed and negative effects on the environment have to be prevented.


    Key Areas of accountability / responsibility

    • Responsible for managing the Operations department (Manufacturing and Manufacturing Support), with responsibility for results on quantity, quality and safety:
    • Responsible for the yearly plans of the Operations department
    • Responsible for setting goals targets and standards for the Operations departments in line with the company goals.
    • Responsible for monitoring of the Key Operating Parameters of the Operations departments
    • Responsible for setting priorities in the planning of actions and resources.
    • Responsible for defining accountabilities, leading the department managers in all aspects of result orientation and transparency.
    • Measure for all the sub departments the output and report results, deviations and issues.
    • Manage a workforce that meets current and future requirements in terms of quality and quantity in order to establish and maintain cGMP compliance
    • Foster the awareness for EH&S and Quality in within and outside the Operations department.
    • Responsible for managing EH&S systems and policies within the Operations department and for creating and maintaining a safe and healthy working environment.
    • Responsible for making and maintaining the Master Production Schedule (MPS) in line with business needs and strategy.
    • Responsible for delivering cGMP-compliant manufacturing processes in a timely fashion according to the company’s business planning.
    • Ensure that activities in the Operations department are within regulatory requirements (EMEA/ FDA guidelines for manufacturing).
    • Ensure that the cleanrooms are maintained in a proper status of operation, order and cleanliness.
    • Formulate, get approval and manage the yearly cost budget for the Operations department
    • Judge and define investment proposals from the Operations department, get approval and manage investments
    • Responsible for cost reduction in fixed costs and continuous improvement in costs within the Operations department.
    • Responsible for managing investments to the Operations Department in order to maintain a ‘state of the art’ manufacturing facility, in line with BU strategy.

      Authorities
    • Directs the Operations Department with full responsibility for safety, quality and quantity of work, staffing, budgets, discipline, salary changes, performance standard and budget. Has the authority to set policies and establish objectives for the functional areas.
    • Member of the site leadership team and reports to the General Manager


    Knowledge and educational level

    • MSc. degree
    • Proven track record in leadership of change
    • cGMP
    • Knowledge and experience in manufacturing of biologics
    • Fluent in English, both in oral and written communication

     
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