CMC Lead (f/m/d)

AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care. To enhance our team in Vienna we are looking for a: CMC Lead (f/m/d) 1190 Wien Vollzeit Start: as of now What Your Day To Day Will Look Like Lead of outsourced pharmaceutical development and life cycle activitiesCMC representative in product development and optimization projects e.g. Tech transfersResponsible for relevant technical documentation and sections of regulatory submissions (IMPD and CTD Modul 3)Providing CMC input in due diligences and portfolio expansion opportunitiesPlanning budgetSupport continuous improvement in the technology, methodology, and AOPs processes as well as recognizing opportunities for cost and risk reduction Your Qualifications and Experience Higher degree in technical or scientific education, preferably chemistry, biotechnology or process engineeringBackground in CMC relevant topics, such as late-stage process and product development and continuous improvement (process and/or analytics)Professional experience in a GMP environment for at least 5 yearsExperienced in applicable EMA/FDA/ICH/WHO/Global regulationsExperience in regulatory submissions and/or back-ground in investigations, OOS, deviations and CAPAs is a benefitHands-on mentality, analytical thinking and good problem-solving skillsCapability of conveying technical and project information in a concise and clear mannerGood verbal, presentation, and written communication skills in English Our offer A position with personal responsibility and space for creativityOpen corporate culture with the opportunity to bring in your own ideasHighly motivated, agile, and international teamGreat opportunities for personal and professional developmentAttractive work environment with excellent career opportunities and flat hierarchiesCompetitive salary package plus bonus and various benefitsGross monthly salary provided for this function is a minimum of EUR 4.500.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications. If you would like to work as a team player in an international environment and can identify with our values "Agile, Ambitious, Aligned, Accountable and Appreciative", then: