CMC Lead

vor 14 Stunden

Wien, Wien, Österreich AOP Orphan Vollzeit

AOP Health is a pioneer in integrated therapies for rare diseases and critical care. To enhance our team in Vienna, we seek a skilled CMC Lead. This full-time role offers personal responsibility and opportunities for creativity.

Your Daily Responsibilities

  • You will lead outsourced pharmaceutical development activities, overseeing life cycle operations and providing input on product optimization projects, including tech transfers.
  • As a key CMC representative, you will be responsible for technical documentation and sections of regulatory submissions (IMPD and CTD Module 3).
  • You will provide essential CMC input during due diligences and portfolio expansion initiatives, ensuring seamless integration with existing processes.
  • Key budget planning responsibilities include allocating resources efficiently to drive business growth.
  • We encourage continuous improvement in technology, methodology, and AOP processes, recognizing opportunities for cost reduction and enhanced efficiency.

Required Qualifications and Experience

  • You hold a higher degree in a technical or scientific field, preferably chemistry, biotechnology, or process engineering.
  • With a strong background in CMC-related topics, such as late-stage process and product development, continuous improvement, and analytics, you have at least 5 years of professional experience in a GMP environment.
  • Your expertise includes applicable EMA/FDA/ICH/WHO/Global regulations, with a proven track record of success in regulatory submissions and/or investigation management.
  • You possess excellent problem-solving skills, hands-on mentality, and the ability to convey complex technical information clearly and concisely.
  • Strong verbal, presentation, and written communication skills in English are essential for effective collaboration within our international team.

Our Offer

  • This position provides ample space for personal and professional growth within our dynamic, agile team.
  • Join an innovative company that values your contributions, encourages open communication, and fosters a collaborative work environment.
  • We offer attractive benefits, including a competitive salary package plus bonus and various perks, such as gross monthly compensation from EUR 4,500.- based on full-time employment, depending on qualifications and experience.

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