Our client is a European pioneer in the development, marketing and distribution of medicines for people with rare and complex diseases. To enhance the R&D team at the Vienna headquarters our client is looking for a CMC Lead (m/f/d).

Your tasks

  • Accountable for CMC activities of one or more marketed products
  • Manage and monitor the subcontracted activities at the respective contract parties (CxOs)
  • Manage the enhancement/improvement of product and process knowledge and general product/project administration
  • Manage together with the respective contract parties (CxOs) Optimisation- and Technology Transfer projects for marketed products
  • Contribute to submission documents (module 3) and responses to authority registration processes (deficiency process)
  • Maintain effective working relationship with contract parties (CxOs)
  • Represent the CMC part in a global project management team and in technical product meetings
  • Work and collaborate with other CMC functions and departments as QM, SCM, RA, PC
  • Compile/create/review CMC relevant documents
  • Evaluate new CxOs for APIs and Finished Products
  • Involvement in contract negotiations, quality agreements and budget monitoring of your projects
  • Be part of AOP’s GMP audit team

Your qualifications

  • Higher degree in technical or scientific education, preferably chemistry, biotechnology or process engineering
  • At least 5 years of professional experience in the pharmaceutical industry
  • Profound experience in the CMC field of oral solid dosage forms and/or parenteral
  • Very good knowledge of guidelines and requirements in the pharmaceutical industry
  • Deep and broad understanding and profound expertise in analytical procedures and handling of impurities is an asset (e.g. ICH Q2(R1), ICH Q3A-Q3E, ICH Q14)
  • Strong communication and presentation skills in English are essential
  • Relevant computer skills (MS Office 365, Adobe Acrobat, Minitab, MS-Project)
  • Well-organized and self-reliant with good interpersonal and communication skills, capable of analyzing and solving complex problems
  • Enjoying to work in a high-performing international environment
  • Preferring a high degree of independence and responsibility for assigned projects
  • Keen to manage multiple projects and being able to prioritize and self-manage

The gross yearly salary provided for this function is a minimum of EUR 56,000 (excluding bonus) based on a full-time employment. Any potential overpayment depends on professional experience and qualifications.

If you are interested in this challenging position, please forward your CV and a recent photograph quoting reference number E1242  to jobs2@eblinger.at

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