CMC Lead
vor 5 Monaten
CMC Lead (f/m/d)
1190 Vienna Vollzeit Start: as of now
What Your Day To Day Will Look Like
Lead of outsourced pharmaceutical development and life cycle activities CMC representative in product development and optimization projects e.g. Tech transfers Responsible for relevant technical documentation and sections of regulatory submissions (IMPD and CTD Modul 3) Providing CMC input in due diligences and portfolio expansion opportunities Planning budget Support 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 engineering Background 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 years Experienced in applicable EMA/FDA/ICH/WHO/Global regulations Experience in regulatory submissions and/or back-ground in investigations, OOS, deviations and CAPAs is a benefit Hands-on mentality, analytical thinking and good problem-solving skills Capability of conveying technical and project information in a concise and clear manner Good verbal, presentation, and written communication skills in English
Our offer
A position with personal responsibility and space for creativity Open corporate culture with the opportunity to bring in your own ideas Highly motivated, agile, and international team Great opportunities for personal and professional development Attractive work environment with excellent career opportunities and flat hierarchies Competitive salary package plus bonus and various benefits Gross 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:
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