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Drug Substance Development Senior Lead - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

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Drug Substance Development Senior Lead

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  • Drug Substance Development Senior Lead
    Location: Antwerp Area, Belgium OR East Paris, France
    Job type: Permanent position

    Salary: €65,000-€80,000 depending on experience

    Job reference: J23478

    - Do you want to be a part of an innovative clinical-stage Biotech company?
    - Is drug substance development CMC your area of expertise?
    - Want to have oversight and leadership over various development projects?
    We are currently working with an innovative biotech company which has received massive funding in recent years. They focus on the discovery and development of small molecule medicines for immune-related diseases.

    Job Description:
    You will be acting as the Lead for drug substance development CMC, responsible for up-scaling strategy and overseeing various development projects
    - Leading API (synthesis and solid state) development
    - Compile/ prepare CMC documentation for clinical trial applications and preparing responses to Agency questions about drug substance
    - Evaluation of stability data and impurity identification
    - Play a leading role in building the CMC development plan
    - Select and manage contractors within the drug substance development department

    Job Requirements:
    - At least 5 years"e; 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
    - Managed CROs
    - 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, Flanders, Antwerp, Flemish, Netherlands, Paris, France, Biotech, Biotechnology, Manager, CMC, Drug substance, Regulatory Affairs,Regulatory Affairs Manager, Lead, Senior, Senior Lead, Drug development, clinical trials, early phase, strategy


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