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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.

CMC Lead (f/m/d)

Professional Skills

  • Natural science/scientific background (FH, university)
  • 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.

Take this AOPPORTUNITY and


Your contact
Angelika Drabek
+43-664-88963746

Take this AOPPORTUNITY and apply now.

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

Take this AOPPORTUNITY and


Your contact
Angelika Drabek
+43-664-88963746