drug product manager

vor 2 Wochen


Munich, Deutschland Discover International Vollzeit

Consultant Technology Management Drug Product TasksAdvise teams for Site-Launch activities for internal and external sites (incl. lab units, SC, RACMC and QA)Communicate with internal and external sites as part of the projectReview technical documentation (protocols, reports) associated with manufacturing, tech transfer, site-to-site transfers and PPQ as neededCommunicate and implement manufacturing plans at the site which are aligned with crossfunctional CMC strategic discussionsCommunicates outcome of key meetings to stakeholders and functional areasConduct data review and analysis, data-driven decision-making process and support data transfer to the appropriate data repository - liaison between the Tech Strategy (data digitalization) and the siteRecommend remediations, CAPAs and provide inspection support as appropriate to mitigate risks or gapsParticipate in the CMC working group meetings and communicate clear, timely and detailed updates on tech transfers and site activitiesAdvice the compilation and technical review of relevant CMC sections of regulatory submissions (MAA), responses to regulatory questions, briefing booksRequirementsPhD (biochemistry, chemistry, pharmacy, engineering or related disciplines) or Master's degree with equivalent professional experience in pharmaceutical sciences preferableSeveral years of experience in the pharmaceutical industry in a drug development environmentExtensive experience in CMC-related functions, including solid formulation processes and product developmentStrong knowledge of CMC development, process development and technology transfer, CMC regulations and GMP compliance in the area of solid dosage formsStrong verbal and written communication skills in English and the ability to work effectively with multinational teams in a multicultural work environmentAdvise global project and cross-functional work teams (e.g. Site Launch Team). Advises CMC work group team in defining scope, assumptions and key objectives to enable effective risk management and ensure adherence to scheduleInfluencing outcomes by negotiating win-win solutions


  • drug product manager

    vor 2 Wochen


    Munich, Bayern, Deutschland Discover International Vollzeit 72.999 € - 109.999 € pro Jahr

    ConsultantTechnology Management Drug ProductTasksAdvise teams for Site-Launch activities for internal and external sites (incl. lab units, SC, RACMC and QA)Communicate with internal and external sites as part of the projectReview technical documentation (protocols, reports) associated with manufacturing, tech transfer, site-to-site transfers and PPQ as...

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