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VP Process Development & Manufacturing CMC 100%
Aussicht: 159
Update Tag: 21-03-2024
Kategorie: Wissenschaft Labor
Industrie: Business Consulting Services
Position: Executive
Jobtyp: Full-time
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Jobinhalt
Our clientGlycoEra AG is a start-up biotech company specialized in the development of glycoengineered biologics and is located in a biotech hub near Zurich, Switzerland. With her CustomGlycan Platform, they aim to unlock the power of glycan-mediated biology to develop novel biologics for a wide range of indications. For the future development and in preparation for the clinical studies in 2024, we want to strengthen the CMC process development and GMP manufacturing expertise. Working location: Wädenswil / ZH
Tasks
- Develop GMP-compliant manufacturing processes for the product candidates capable to meet quality expectations for therapeutics
- Overseeing the design and execution of studies, process investigations, data analysis, and writing/review of technical reports.
- Develop GMP compliant manufacturing processes for the product candidates capable to meet quality expectations for therapeutics
- Plan and supervise on-going work in the up- and downstream teams to allow on-time delivery of materials for pre-clinical and clinical studies
- Improve the manufacturing processes towards high performance, robustness, GMP compliance and high yields
- Lead the manufacturing CMC parts, ensuring that all relevant documentation will be provided by the SMEs
- Search and evaluate CMOs for clinical production and leading the TechTransfers to external partners
- Extensive experience in industrial up- and downstream process development for large molecule biologics
- Ability to work independently and as a team player in a multicultural environments Kinetoplastida is desired
- 10+ years’ experience in biotech industrial process development is a must
- 5+ years’ experience in technology transfer to external partners
- Proven track record of preclinical and clinical formulation and drug product development
- Experience in GMP manufacturing and CMC regulatory requirements
- Excellent leadership, negotiation, and communication skills in English, German and additional languages are an asset
- Good IT knowledge (Excel, databases, statistical software)
- Ability to work independently and as a team player in a multi-cultural environment
- Challenging and inspirational tasks within a hot research area and a unique approach to target protein degradation
- You will work in an attractive work environment within an international, motivated, supportive, and friendly team
- Attractive compensation package standard in the industry
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Frist: 05-05-2024
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