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Administracja biurowa » Pracownik biurowy

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Drug Substance Development Senior Lead - Biotech Nr ref.: /JOBS.pl Drug Substance Development Senior Lead - Biotech Location: Antwerp Area, Belgium OR East Paris, France Job type: Permanent position Salary: €70,000-€90,000 depending on experience Job reference: J23999 - Are you looking to use your strong drug substance development experience to work for an innovative clinical-stage Biotech? - Want to lead and project manage various development projects? - Do you have an interest in growing with a highly successful mid-sized company? We are currently supporting a very successful clinical-stage Biotech company who have formed partnerships with some of the biggest names in the industry. They focus on small molecule medicines for immune-related diseases. Job Description: You will be acting as the Senior Lead for drug substance development CMC, responsible for up-scaling strategy and overseeing various development projects. - Leading API (synthesis route and solid state) development - Manufacturing non GMP and GMP batches and upscaling - Compile/ prepare CMC documentation for clinical trial applications and preparing responses to Agency questions about drug substance - Evaluation of stability data and impurity identification - Lead and build the CMC development plan - Select and manage CRO&quote;s and contractors within the drug substance development department Job Requirements: - At least 5 years&quote; experience in drug substance development CMC - Strong theoretical and practical knowledge of the drug development process - Experience in preparing drug substance development reports for CMC sections of IND/IMPD/NDA submissions - Fluent English Remember if this role is not suitable for you or you are no longer looking for a new job please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice. Key words: Belgium, Mechelen, Flanders, Antwerp, Flemish, Paris, France, Romainville, Biotech, Biotechnology, Manager, CMC, Drug substance, Drug substance development, GMP, Regulatory Affairs, Regulatory Affairs Lead, Senior Lead, Drug development, clinical trials, early phase, early phase drug development Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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