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CMC Lead (f / m / d)

CMC Lead (f / m / d)

AOP OrphanWien, DE
Vor 30+ Tagen
Gehalt
4.500,00 € monatlich
Stellenbeschreibung

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 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 :