Process Supporter for API Production Processes

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Hillerød

Are you curious about a dynamic role where you'll drive innovation in API production? We are seeking two process supporters to join our innovative team in Hillerød – one focusing on purification processes and another working with mammalian/microbial cell cultures. If you're passionate about bringing new pharmaceutical products to market and thrive in a collaborative environment, this is your chance to make a significant impact. Apply now and be part of our groundbreaking journey in a dynamic business area that produces Active Pharmaceutical Ingredients (API) for patients across the world.The PositionIn this position, you will play a pivotal role in supporting process validation and managing campaigns, including the meticulous submission of product documentation to regulatory authorities. Your success will be measured by how effectively and smoothly the new processes run under GMP standards across multiple production batches.Given that our projects are in the late phase of technical transfer, your role will involve running and optimizing production campaigns with new products post-process validation. This phase will require you to monitor, learn, and continuously improve the production processes. One of your main tasks will be to write and refine regulatory documents needed for product submission as we approach these critical milestones.The processes you will engage with include mammalian cell cultivation, recovery, and purification. We are looking for one supporter to focus on upstream processes and another on downstream/purification processes.Your key responsibilities will be:
  • Writing submission documents and participating in Q&A rounds after submission.
  • Preparation for (Pre License) Inspections and audits on new products.
  • Coordination of activities with internal and external stakeholders (process development, equipment, facility, production, automation, and QA).
  • Preparing and supporting campaigns for new products, including required documentation in accordance with the current standards and legislations, change requests, and process deviations.
  • Ensuring technology, process, and knowledge transfer between development and production.
  • Troubleshooting related to the daily manufacturing of new products.
  • Initiating problem-solving (A3 or similar) for observed process deviations or other issues in the production of the new products.
    • QualificationsTo succeed in this position, you:
  • Have an education as a bioengineer, biotechnologist, biochemist, or similar.
  • Have a minimum of 6 years of experience with the production and/or development of pharmaceutical products.
  • Speak English and Danish (minimum conversational level).
  • Have experience in mammalian cell culture/purification of proteins with changing products under GMP. You also have experience with late-stage product development and filing of new products.
    • As a person, you have strong analytical skills and preferably solid knowledge of cell cultivation processes. You are structured and proactive in your work, good at working independently, and making data-based decisions that are within our GMP framework as well as support our strategic goals. LEAN is a natural part of your skill set. You will have several stakeholders across the organization, and therefore your written and spoken communication skills in both Danish and English must be excellent. To succeed, you need to be able to keep a cool head and make decisions in a busy work environment where the agenda changes frequently.The departmentIn this role, you will be at the forefront of ensuring the successful technology and process transfer of new API processes into our production facilities. This critical function involves close collaboration with your colleagues from production and other key departments such as equipment, maintenance, calibration, IT/Automation, and QA. As a Process Supporter in the New Products team, you will be responsible for transferring new products from development to full-scale production.As our projects mature, we are now in the late phase of the technical transfer, meaning that we run campaigns with the new products after process validation, where we monitor, learn and then optimize production. Focus for the New Products team is to ensure to drive these activities and as we are approaching submission, write the regulatory documents.ContactFor further information, please contact [xxxxx] 27.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 Hillerød.

    Jobbet er oprettet på vores service den 14.4.2025, 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.
    • 14.04.2025
    • Øvrige
    • Hillerød
    Rapportér

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