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Process Development Lead

vor 2 Monaten


Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit
About the Role

We are seeking a highly experienced and skilled Tech Management Lead to join our team at Daiichi Sankyo Europe. As a key member of our organization, you will be responsible for the management of technology transfer of manufacturing processes for drug substance, including Antibody-Drug Conjugates, to internal and external sites.

Key Responsibilities
  • Lead and coordinate Site-Launch activities and associated teams for internal and external sites and development projects.
  • Act as main interface to internal and external sites, ensuring seamless communication and collaboration.
  • Review technical documentation associated with manufacturing, tech transfer, site-to-site transfers, and PPQ as needed.
  • Conduct scouting activities and recommend Contract Development and Manufacturing Organizations (CDMOs) for clinical and launch site selection.
  • Communicate and implement manufacturing plans at the site, aligned with cross-functional CMC strategic discussions.
  • Communicate 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.
  • Recommend remediations, CAPAs, and provide inspection support as appropriate to mitigate risks or gaps.
  • Participate in 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.
Requirements
  • Ph.D. (biochemistry, chemistry, pharmaceutics, engineering, or related disciplines) or master's degree with equivalent work experience to doctoral degree within pharmaceutical/biotechnology sciences.
  • At least 4 years of experience or more in the pharmaceutical/biotechnology industry working in a process development environment.
  • Extensive experience in CMC related functions, including biopharmaceutical process (preferably drug substance manufacturing) and product development.
  • Strong knowledge of CMC development, process development, and technology transfer, CMC regulatory, and GMP compliance in the field of biopharmaceutical drug substances.
  • Strong verbal and written communication skills in English and ability to interface effectively with multi-national teams in a multi-cultural work environment.
  • Leadership skills, with experience in leading global project and cross-functional working teams.
Why Work with Us?

At Daiichi Sankyo Europe, we are committed to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. We foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. If you have a proactive mindset and passion for addressing the needs of patients, we encourage you to apply for this exciting opportunity to join our team.