Biologist (m/f/d)

Vor 5 Tagen


Biberach, Deutschland GULP – experts united Vollzeit

We are currently looking for a qualified Downstream Process Transfer Engineer on behalf of a business partner. Use our service as a springboard into an attractive company in the pharmaceutical industry in Biberach . Apply directly online now - or contact us by phone or e-mail and let our friendly colleagues advise you without obligation. By the way: We value equal opportunities and welcome applications from people with disabilities, whose inclusion is of particular concern to us.

Here's what we offer

Attractive salary and long-term job security through group affiliation Reimbursement of travel expenses Up to 30 days' vacation per year Skills development through a variety of e.learnings Regular appraisal interviews

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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