Outsourcing Professional for Aseptic Production

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Måløv

Are you motivated by the opportunity of being part of an ambitious process support team collaborating with internal stakeholders in project teams and Contract Manufacturing Organisations (CMO) globally?
Do you have experience with aseptic production and a strong interest in working with some of our existing new drug candidates in clinical development? Then please keep reading as you might be our new colleague.
We are hiring new colleagues to build up competences and ramp-up for exciting and increased activities at CMO’s around the world.
The position
You will be part of the Outsourced Production team in CMC Aseptic Pilot Plant with currently 10 dedicated colleagues. Together with colleagues within the team and across departments you will be driving project activities related to CMO productions.
Your main task will include the following:
  • Responsible for manufacturing activities incl. batch documentation.
  • Input to production facility and processes.
  • Communication with CMO before, during and after production.
  • Contribution to problem solving and handling of deviations.
  • Together with QA drive the release process including batch review.
  • As you will be supporting productions globally (primarily Europe) some travel can be expected

    Qualifications
  • A relevant higher academic degree within pharmacy, engineering, science or similar.
  • Experience with aseptic production of injectables – eg. filling and formulation
  • Preferably experience working with outsourcing activities.
  • Fluent in spoken and written English.
  • As we are stronger together you must see yourself as a team player with great ability of building relations with stakeholders in very dynamic project teams while creating collaboration in a global environment. You must be eager to learn and develop your skills. About the Department
    At Aseptic Pilot Plant (APP), we are in the exciting interface between development and production and therefore have broad contact with many different functions in [xxxxx]. We manufacture injectable sterile products for clinical trials - primarily phase 1 and 2. The products vary, but they are all produced according to applicable GMP requirements in an aseptic environment. Some of these products are outsourced, and we therefore have partners globally.

    We have an exciting everyday life where tasks are challenging and varied. We approach tasks with curiosity and the desire to make a difference. APP is located in Måløv and is part of CMC Drug Product & Analytical Development. The department consists of approximately 90 employees - all on day shift - and includes process areas such as washing & sterilization, formulation, filling, inspection, supply, environment, cleaning, maintenance and calibration.

    Working at [xxxxx]
    At [xxxxx], we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

    Contact
    If you want to know more about this position, please contact Associate Manager Jens Oluf Eriksen at +[xxxxx].

    Deadline
    Apply before November 14, 2024 We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


    Information og data

    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Måløv.

    Jobbet er oprettet på vores service den 31.10.2024, men kan have været deaktiveret og genaktiveret igen.

    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • 31.10.2024
    • Øvrige
    • Måløv

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