AOP Orphan is a European pioneer in the development, marketing and distribution of medicines for people with rare and complex diseases. To enhance our team in Vienna we are looking for a:
AOP Orphan is a European pioneer in the development, marketing and distribution of medicines for people with rare and complex diseases. To enhance our team in Vienna we are looking for a:
CMC Lead (f/m/d)
As part of our Pharmaceutical Development team you will play a key role in managing CMC related activities for development products.
Practical experience in CMC development and lifecycle of oral solid dosage forms or parenteral products (injectables, lyo) – formulation, manufacturing, analytics and their controls (cMA, cPP, cQA etc.)
Profound operational pharmaceutical quality knowledge and reasonable implementation of GMP and CMC regulations/guidelines
At least 5 years working experience in the pharmaceutical industry
Strong communication and presentation skills in English and German
Strong IT skills (MS Office, Adobe Acrobat, Minitab, MS-Project)
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 (CDMOs)
You plan and execute CMC activities for marketed products (product lifecycle-management) and manage the practical activities at the respective contract parties (CxOs)
You create CMC relevant documents, and you draft dossier (module 3) sections and responses to authority registration processes (submission, deficiency process, lifecycle/variations)
You plan and monitor the budgeting for your project/product
Like to take accountability?
You evaluate new CxOs for APIs and Finished Products together with contributing departments as Business Development and SCM/QM
You are involved in contract negotiations/quality agreements and budget monitoring of your projects
You will be part of AOP’s GMP audit team and execute QM documents (e.g. change controls, deviations)
You manage the improvement of product and process knowledge and general project administration
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 contribute to the CMC strategy and dossier preparation with the CMC RA group
You represent the CMC part in a global project management team and in technical product meetings
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
The gross monthly salary provided for this function is a minimum of € 4.000.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications.
The gross monthly salary provided for this function is a minimum of € 4.000.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications.
Ihr Ansprechpartner
Angelika Drabek
+43 1 503 72 44-62
