Biologist (Scientist)
vor 3 Wochen
**Unlock Your Potential in a Dynamic Pharmaceutical Environment**
Are you a seasoned professional seeking a new challenge in the pharmaceutical industry? GULP – experts united is looking for a highly skilled individual to join our team as a Downstream Process Transfer Engineer. We offer a secure job, attractive benefits, and exciting tasks that will help you grow professionally.
**What We Offer**
- Competitive salary package with bonuses
- Extensive social benefits, including bonuses and vacation entitlement
- Tailored training opportunities and language courses
- Discounts at sports, leisure, and wellness facilities
**Your Key Responsibilities**
- Planning and implementation of complex transfer projects in early stage biologicals (CMC I) and late stage biologicals (CMC II)
- Preparation of high-quality project-related transfer documents, taking into account current legal basis and international regulatory guidelines
- 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
- Managing direct process transfer of external customers
- Representing projects and 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
- Managing cross-site process transfers within the global biopharma network
**Your Profile**
- 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, analytical, and conceptual strength
- Strong teamwork and communication skills, resilience, and initiative
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