Senior Professional - Aseptic Process and Equipment

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Søborg

Do you have a passion for aseptic production processes and/or equipment, and does ensuring alignment between our internal standards and our Contract Manufacturing Organization’s (CMOs) around the world sound like your next career mission?Then you might be the Senior Professional (we are looking for to join the Global Contract Manufacturing (GCM) Drug Product (DP) External Manufacturing Technology and Optimization (EMTO) department.The PositionAs Senior Professional EMTO, you will collaborate with EMTO specialists and senior professionals on technology transfer projects for pre-filled syringes, cartridges, and vials to our CMO partners.You will play a key role in implementing new products, processes or equipment at CMO sites, by bringing aseptic expertise to the table while gaining in-depth knowledge of [xxxxx] processes and products to provide technical support to external production operations.In this position, you:
  • Work closely with our team of EMTO specialists, professionals, support and internal stakeholders ensuring the implementation of a robust production process at our CMO partners.
  • Gain and hold extensive knowledge of the production including the formulation preparation, filling, inspection, the production equipment, facilities and other processes related to the manufacture.
  • Deliver insight of the production operations and drive solutions whenever production disturbances occur.
  • Provide procedural, process and engineering recommendations, offer necessary competencies, and address obstacles to ensure the team achieves its goals and delivers measurable results.
  • Have a strong interaction with [xxxxx] Manufacturing development areas.
    • Several of the CMOs we currently work with are in project phases where extra focus is needed, leveraging a varied day with diverse tasks and ample opportunity for development. The position has a high degree of independence as well as the opportunity to travel frequently within Europe, USA, Asia or Africa (expected around 30-60 days per year.QualificationsTo be considered for this position, we expect you to:
  • Hold a master’s degree within Pharmacy, Engineering, Chemical Engineering, orsimilar.
  • Bring solid practical experience in the pharmaceutical industry, particularly in the manufacturing of sterile drug products such as pre-filled syringes, cartridges, and vials.
  • Have some knowledge with Lean 6 Sigma or equivalent, have experience working in technology transfer projects, and/or life cycle management projects within drug product manufacturing operations (i.e. Formulation, filling, inspection, etc.), or implementation/optimization of new equipment.
  • Possess GMP knowledge along with a strong understanding of drug product manufacturing practices, including aseptic filling processes, isolator and Rabs technology.
  • Know the FAT, SAT, Qualification and Validation processes
  • Have experience from a diverse and international environment.
  • Be able to - and motivated by - being on-site at global locations.
    • To thrive in this role, you enjoy building international relations and involving relevant parties to drive your tasks forward. You prefer a structured an analytical approach to effectively manage multiple activities. While you thrive working independently, you also value collaborating and sharing knowledge with your peers.About the DepartmentGCM Drug Product is part of [xxxxx]’s Product Supply organization. We are responsible for all [xxxxx] contracts and license manufacturing of semi-finished and finished drug products to global markets. We, in DP EMTO, bear the responsibility for the production, the QMS and the facility including all equipment, and we work closely with our GCM Operations team providing technical/expertise support during Commercial supply. You will join the GCM DP EMTO AP team consisting of highly experienced specialists and competent professionals with backgrounds in both pharmaceutical sciences and engineering. You will become a part of an international, diverse and well-functioning team that excels at solving problems in collaboration.Our main office is in Taastrup, Denmark and our CMOs are in Central Europe, North America, East Asia and South Africa.Working at [xxxxx]We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at [xxxxx], life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.ContactFor further information, please contact Julio Cesar Crepaldi Santiago GCM DP EMTO AP Director, at +[xxxxx].DeadlineApril 25th 2025.You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.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.


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

    Arbejdsstedet er beliggende i Søborg.

    Jobbet er oprettet på vores service den 14.2.2025, men kan have været deaktiveret og genaktiveret igen.

    Rapportér
    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • 16.04.2025
    • Øvrige
    • Søborg
    Rapportér

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