Biological Process Engineer

Vor 3 Tagen

Biberach an der Riß, Baden-Württemberg, Deutschland GULP – experts united Vollzeit

Are you ready for a new challenge in the pharmaceutical industry? We are looking for a skilled Downstream Process Transfer Engineer to join our team at GULP – experts united in Biberach. As a secure and attractive job with exciting tasks, we offer a unique opportunity to grow professionally and personally.

What we offer:

  • Attractive salary package with Christmas and vacation bonus
  • Extensive social benefits, including Christmas and vacation bonuses
  • Vacation entitlement of up to 30 days per year
  • Tailored training opportunities and free language courses
  • Discounts at sports, leisure and wellness facilities

Your tasks:

  • Planning and implementation of complex transfer projects in the field of early stage biologicals (CMC I) and late stage biologicals (CMC II)
  • High-quality and timely preparation of project-related transfer documents, taking into account the current legal basis and international regulatory guidelines (process descriptions, transfer reports, facility fit analyses and risk analyses)
  • Management of product transfer activities for clinical production facilities in the downstream area (purification)
  • Preparation of approval documents and answering queries from authorities
  • Collaboration with internal customers from development and commercial production facilities as well as external customers in the CMB business (contract manufacturing business)
  • Managing the direct process transfer of external customers
  • Representing the projects and the clinical production facility in interdisciplinary teams and cross-functional meetings
  • Acting as an expert for process technology issues in the production of biopharmaceutical molecules
  • Leading expert meetings
  • Representing the division in cross-functional meetings and interdisciplinary teams
  • Manage cross-site process transfers within the global biopharma network

Your profile:

  • Successfully completed studies in biology, (bio)chemistry, (bio)pharmacy, bioinformatics or comparable training with several years of relevant professional experience
  • Experience with biopharmaceutical manufacturing processes upstream (mammalian cell culture) or downstream (purification), their development, production and project management
  • Good understanding of biopharmaceutical manufacturing processes, ideally with a focus on downstream (purification)
  • Understanding of the requirements of GMP-regulated areas
  • Business fluent in written and spoken German and English
  • Quick comprehension as well as analytical and conceptual strength
  • Strong teamwork and communication skills, resilience and initiative

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