Ansprechpartner
Nadja Küppers
+49 (0)89 7263 210 – 09
kueppers@ageneo.de
Branche
Pharmazeutische Industrie
Berufsfeld
QM
Region
Bayern

DAS UNTERNEHMEN

For an innovative biotech company in southern Germany we're looking for a manager quality/ CMC (m/f/d) in the field of gene therapy. The position can be either be a full time or a part time one. 

 

IHRE AUFGABEN

  • Development and maintenance of a Quality Management System together with external experts
  • Prepare, execute and follow up internal, external and supplier audits
  • Preparation and development of processes and description thereof in SOPs
  • Support acquisition of a manufacturing license for therapeutic products
  • Lead or participate in quality management improvement projects
  • Author and review of quality related documents
  • Be the main contact person for colleagues from other departments encountering quality related questions
  • Plan and execute training arrangements for colleagues and new employees with regard to the quality management system
  • Support or lead on CMC related questions and documentation

IHR PROFIL

  • M.Sc. or Ph.D. in molecular biology, virology, biotechnology, pharmacology or related field
  • Multiannual work experience in quality management in industrial settings, preferably in biopharmaceutical industry or at a CDMO
  • Proficient knowledge on national and international standing regulations (GMP
  • Experience in planning and execution of internal, external and/or supplier audits
  • Basic knowledge about largescale AAV manufacturing
  • Able to work under minimal supervision, be teamoriented and collaborative, able to multitask and manage different projects
  • Outstanding communication skills
  • Language proficiency (English fluent in spoken and written)
  • Knowledge of AAV molecular biology would be a nice to have
  • In depth understanding of AAV manufacture in industrial settings as well as relevant CMC technologies and documentation thereof would be a nice to have

BENEFITS

  • Position based in a very attractice area of southern germany
  • multicultural teams and an open corporate culture
  • an inspiring working atmosphere as fertile ground for your further development
  • an interesting chance in an exciting industry