Araris Biotech AG is a PSI and ETH spin-off company based at ETH Zürich-Hönggerberg, Switzerland, developing highly innovative next generation antibody-drug conjugates (ADCs) using its proprietary Linker and Enzymatic Bioconjugation Technology. The company is in the process of transitioning from research into development stage. Therefore, we are currently looking for a CMC expert to drive CMC development from preclinical into clinical stage.
Reporting line and accountability:
- You will directly report to Chief Development Officer (CDO)
- You will be accountable for the strategic planning and execution of all CMC activities
- Quality: Responsible for establishment of the manufacturing platform and drug supply chain, including CDMO and supplier selection, qualification, auditing, and continuous progress monitoring with support of external Subject Matter Experts as needed.
- Technical Operations: Direct and coordinate the company’s overall CMC operational management activities, including process and analytical development, GMP production as well as distribution of materials, intermediates, drug substance, drug product, and the investigational medicinal product.
- Project Management: Responsible for CMC project management and integration of CMC plan with full transparency of timelines, costs, risk analysis, and risk mitigation.
- Regulatory Affairs (RA): Responsible for CMC-regulatory compliance, regulatory submissions of CMC-related IND/IMPD dossier, coordination of RA experts, and interactions with Health Authorities.
- MS, PharmD or PhD in biochemistry, biochemical engineering, chemistry, or other discipline within pharmaceutical/biotechnology sciences with ideally ³ 5 years of industrial experience.
- Strong background and experience in the development of New Biological Entities (NBEs) and/or New Chemical Entities (NCEs).
- Track record in CMC development of ADCs including antibody development, linkers, payloads and (enzymatic) conjugation technology would be highly appreciated.
- Experience in enzymology, bioengineering and bioconjugation would be a plus.
- Good communication, presentation, organizational skills and passionate about working in a start-up company that is rapidly evolving.
- Most importantly, we look for a strong and motivated team player.
If you feel ready for this exciting journey at Araris Biotech, then please send us your documents (motivation letter and CV in a single PDF file) by email no later than July 12th, 2021: email@example.com.