CMO Tech Transfer Lead

vor 3 Wochen

Neuenburg, Schweiz AurigaVision AG Vollzeit
CMO Tech Transfer Lead – Drug Substance (Ref. 2424)6-8 Month contract

Our client is responsible for some of the most important latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. They are looking for a senior Consultant to help with Tech Transfer activities associated with Biological Drug Substance from inhouse in Switzerland to a contract manufacturing organization (CMO) in Incheon South Korea.

Your main tasks:

  • Primary focus will be to support technology transfer activities to the new CMO in South Korea.
  • Responsible for supporting commercial manufacturing performance at the external manufacturing site.
  • Maintains strong working relationships with external and internal partner(s).
  • Ensures effective communication between technical transfer internal and external team.
  • Represents MS&T external manufacturing team to provide technical support to the biological drug substance tech transfer process including deviation resolution, change management, delivery of yield targets and process optimization.
  • Interface with internal functions such as MS&T, Quality, and Supply Chain.
  • Ensures timely escalation of potential technical, compliance or safety issues to the MS&T team.
  • Implement and maintain high standard of quality and regulatory compliance to meet and exceed regulatory agency and quality requirements.

Your profile:

  • Scientific degree (min. BSc or MSc) as well as several years of GMP regulated industry experience.
  • Science or engineering degree in chemical engineering, mechanical engineering, biotechnology, biochemical or related discipline.
  • Experience in drug substance manufacturing is essential.
  • A strong practical knowledge of the technologies related to mammalian cell culture, therapeutic protein purification and process engineering.
  • Demonstrated ability to work independently and prioritize activities, as well as to provide leadership.
  • A proven ability to work on complex problems in which analysis of situations/data requires an in-depth evaluation of multiple factors is essential.
  • Ability to work in a multi-disciplinary team, partner with various functions to provide strong leadership to drive risk-based decisions.

Sebastian Pal is looking forward to receiving your application documents via job portal (CV, diploma, reference letters; no motivational letter necessary). Full discretion is guaranteed and we will gladly answer any additional questions.

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