Tech Management Lead

vor 4 Wochen


Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

About the Role:

The Tech Management Lead Drug Substance is responsible for the management of technology transfer of the manufacturing processes of drug substance for investigational and commercial drugs to the sites of manufacture, both internal and external to Daiichi Sankyo, until transition to routine manufacture.

Key Responsibilities:

  • Lead and coordinate the Site-Launch activities and associated teams for internal and external sites and development projects
  • Act as main interface to internal and external sites
  • Review technical documentation associated with manufacturing, tech transfer, site-to-site transfers and PPQ as needed
  • Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. Drug Substance perspective
  • Communicate and implement manufacturing plans at the site which are aligned with crossfunctional CMC strategic discussions
  • Communicates outcome of key meetings to stakeholders and functional areas
  • Support technical recommendations for future sites and their selections
  • Collect and share key data from KPI perspective to improve drug substance manufacturing site performance
  • Conduct data review and analysis, data-driven decision-making process and support data transfer to the appropriate data repository - liaison between the Tech Strategy (data digitalization) and the site
  • Recommend remediations, CAPAs and provide inspection support as appropriate to mitigate risks or gaps
  • Participate as in the CMC working group meetings and communicate clear, timely and detailed updates on tech transfers and site activities
  • Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses to regulatory questions, briefing books
  • Coordinate with lab units, SC, RACMC, QA to drive collaboration and solves issues in Tech Mgmt. Drug Substance team

About You:

We are seeking a highly qualified candidate with a Ph.D. (biochemistry, chemistry, pharmaceutics, engineering, or related disciplines) or master's degree with equivalent work experience to doctoral degree within pharmaceutical/biotechnology sciences.

What We Offer:

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients' lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.



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