(Senior) Specialist Stability Studies– Quality Control

Date posted: 03. August 2022
Location: Vienna

Position Summary

The QC Specialist manages program-specific stability studies, oversees stability related activities and ensures timely execution at external contract laboratories. Monitoring and analyzing data as well as summarizing the results and conlusion in a report are also part of this function.

Main Responsibilities
  • Management of Stability Studies for Drug Products, Drug Substances, and Intermediates stored under several conditions (long-term, accelerated studies, In-Use stability studies)
  • Generation of Stability Protocols and Reports
  • Ensuring timely testing of stability samples within the analytical test window at external contract laboratories
  • Data monitoring and trending as well as statistical analysis
  • Support evaluation of shipping and handling excursions
  • Ownership of OOS/OOE events, deviations and changes with regards to stability
  • Act as subject matter expert for stability relevant sections for regulartoy submissions
  • Contribute to continuous improvements and process optimization of HOOKIPA’s Quality Management System

Qualifications

  • University degree in natural sciences or equivalent technical discipline required, ideally in Biochemistry, Biotechnology or Pharmacy
  • Strong experience in Quality Control and/or Quality Assurance
  • Profound biotechnological and/or pharmaceutical understanding
  • Particular knowledge of stability studies with gene therapy products is a strong plus
  • Hands-on knowledge of EU GMP regulation
  • Experience with quality systems (OOS investigations, deviations, CAPAs, and change controls)
  • Competence in Microsoft Office Tools
  • Fluent in English, both spoken and written
  • Valid EU working permit

What we offer

  • Strong team with dedicated and passionate employees
  • State of the art infrastructure
  • An excellent working atmosphere
  • Opportunities for personal development
  • Employee benefits such as health screening, public transportation card, Sodexo pass
  • Working in a multinational and multicultural environment

We are required by Austrian law to post a minimum salary. The minimum monthly gross salary for this position is EUR 2.754,- (Specialist) based on fulltime (40 hours per week); depending on experience and qualification salary can be negotiated. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.

Starting date: as soon as possible

Contact:

If you (m/f/d) are interested in this challenging position, please send your CV including a cover letter (summarizing your qualification and experiences) as well as your credentials to: talent@hookipapharma.com

For more information on HOOKIPA please visit www.hookipapharma.com

 

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