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