Biologist (Scientist)
vor 2 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 invites you to explore a secure and rewarding career opportunity as a Downstream Process Transfer Engineer.
**What We Offer**
- A competitive salary package with comprehensive benefits, including a Christmas bonus and vacation entitlement of up to 30 days per year
- Extensive social benefits, including a vacation bonus and discounts at sports, leisure, and wellness facilities
- Tailored training opportunities and free language courses to enhance your skills and knowledge
**Your Key Responsibilities**
- Plan and implement complex transfer projects in early stage biologicals (CMC I) and late stage biologicals (CMC II)
- Prepare high-quality project-related transfer documents, adhering to current legal basis and international regulatory guidelines
- Manage product transfer activities for clinical production facilities in the downstream area (purification)
- Prepare approval documents and respond to queries from authorities
- Collaborate with internal customers from development and commercial production facilities, as well as external customers in the CMB business (contract manufacturing business)
- Manage direct process transfer of external customers
- Represent projects and clinical production facilities in interdisciplinary teams and cross-functional meetings
- Act as an expert for process technology issues in biopharmaceutical molecule production
- Lead expert meetings and represent the division in cross-functional meetings and interdisciplinary teams
- Manage cross-site process transfers within the global biopharma network
**Your Ideal 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 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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