CMC Lead Pharmaceutical Development (f/m)

AOP Orphan Pharmaceuticals AG
  • Wien
  • Vollzeit
  • Berufserfahrung
  • 17.8.2018

AOP Orphan Pharmaceuticals AG is a European pioneer with focus on rare diseases. We develop and market innovative solutions beyond drugs. To enhance our team in Vienna we are looking for a:

CMC Lead Pharmaceutical Development (f/m)

As part of our Pharmaceutical Development team you will play a key role in managing CMC related activities for development products.

Ready for an ambitious job?

  • You plan and execute the CMC strategy for new development products and manage the practical activities at the respective contract parties
  • You are strongly involved in CMC dossier preparation and authority registration processes of the CMC part (submission, deficiency process, life-cycle/variations)

Able to align?

  • You work and collaborate with other CMC Leads in a dynamic team
  • You ensure effective communication with external partners and monitor subcontracted activities
  • You strongly coordinate the CMC strategy with the Regulatory Affairs department
  • You are the CMC part in a global project management team

Looking for an agile environment?

  • You enjoy working in a high-performing international environment
  • You prefer a high degree of independence and responsibility for assigned projects
  • You are keen to manage multiple projects and being able to prioritize and self-manage

Professional skills

  • Natural science/scientific background (HTL, FH, university)
  • Practical experience in CMC development of oral solid dosage forms or parenteral products (injectables, lyo) - formulation, manufacturing and analytics
  • Profound operational pharmaceutical quality knowledge and reasonable implementation of GMP and CMC regulations/guidelines
  • Strong communication and presentation skills in English and German
  • IT skills (MS Office, Adobe Acrobat, alternatively MS-Project)

The gross monthly salary provided for this function is a minimum of EUR 4.000, - based on full-time employment. Any potential overpayment depends on professional experience and qualifications.

If you like this AOPPORTUNITY please send your application to:

Angelika Drabek
AOP Orphan Pharmaceuticals AG
Wilhelminenstraße 91/II f, 1160 Wien
Tel.: 01/503 72 44-62, Fax: 01/503 72 44-61

Original-Inserat anzeigen

AOP Orphan Pharmaceuticals AG

Pharma, Chemie, Biotech
101 - 500 Mitarbeiter

Über uns

AOP Orphan erforscht, entwickelt, produziert und vertreibt weltweit innovative Präparate und Applikationen zur Behandlung seltener Erkrankungen – und ist damit ein europäischer Pionier im Bereich Orphan Diseases. AOP Orphan wurde 1996 von Dr. Rudolf Widmann in Wien gegründet, um…