Offre d'emploi : CMC Manager - Biologics (M/F)
Amyl Therapeutics is a drug discovery biotech company pioneering a breakthrough approach to treat rare and severe peripheral protein misfolding diseases and neurodegenerative diseases.
Based in Liège (Belgium), Amyl Therapeutics’ unique and innovative technology offers a curative solution for all forms of amyloid mediated disease. In June 2021, the company completed a €18 million Series A financing. As a well-capitalized biotech company Amyl Therapeutics is positioned to continue to develop its R&D projects pipeline. For more information, please visit www.amyltx.com.
To expand its pipeline and reinforce its team, Amyl Therapeutics is looking for a (m/f): CMC Manager – Biologics.
Reporting to the CSO, you coordinate the CMC operational and technical aspects of therapeutic development projects. This includes Drug Substance and Drug Product manufacturing process and analytical development. In close collaboration with the R&D team, you set up, lead and manage the CMC development plan from preclinical to clinical stage.
- Develop and implement an ambitious CMC strategy for the R&D projects.
- Identify and select CDMOs and subcontractors from the RFI to the final choice.
- Manage CDMOs for process development/optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of R&D projects.
- Ensure a smooth transition from Preclinical to Clinical stage development in CMC.
- Participate in the development of analytical methods and stability plans.
- Manage of supply chain and logistics in support of clinical studies.
- Execute the validation and registration of API and DP following cGMP, ICH and FDA regulations.
- Write and review documents for INDs / IMPD/ regulatory section submissions.
- Review or edit cGMP batch records, CMC regulatory and Quality documents.
- Report to COMEX work evolution on a regular basis.
- PhD in Biochemistry/Chemistry, Bio-Engineering or Biotechnology or Master’s Degree in Bio-Science, or equivalent though experience.
- 5 to 10 years of experience in CMC within the biopharma industry. Experience with cell culture is a plus.
- Substantial experience working with CDMOs for the production of DS and DP.
- Experience with projects in (pre)clinical development.
- Thorough understanding of the drug development process.
- Analytical, rigorous, detail-oriented, autonomous, committed, and flexible.
- Open-minded with strong team spirit and excellent interpersonal skills.
- Excellent oral and written communication skills in English.
- Willing to travel worldwide.
- A new stimulating position within a small high-potential innovative biotech company.
- The opportunity to work in a science-driven, respectful and professional environment.
- A challenging scientific project in which you get to bring your knowledge and skills.
- A permanent contract (employee or management company) with an attractive salary package in line with the position responsibilities and your experience.
Send your CV together with an adapted cover letter via https://www.pahrtners.be/en/jobs/cmc-manager-biologics-mf-en/ or to the following address: firstname.lastname@example.org.
Your application and related information will remain strictly confidential.
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