CMC Lead (f/m/d)

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)

Professional Skills

• Natural science/scientific background (FH, university)
• Practical experience in CMC development and CTM manufacturing of oral solid dosage forms or parenteral products (injectables, lyo) - key words API or formulation development, manufacturing, analytics, process control (cQA, cPP, cMA, 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 control strategy for new development products
• You manage the practical activities at the respective contract parties (CDMOs) including manufacturing of CTMs
• You create CMC relevant documents, and you draft dossier sections (IMPD)
• 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
• 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 EUR 4.000.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications.

Take this AOPPORTUNITY and apply now.

Your contact
Angelika Drabek
+43-664-88963746