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)
- 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.