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vor 1 Monat
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Tech Management Lead
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Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitJob Title: Tech Management Lead - Drug SubstanceAt Daiichi Sankyo Europe, we are seeking a highly skilled Tech Management Lead - Drug Substance to join our team. As a key member of our organization, you will be responsible for managing technology transfer of manufacturing processes for drug substance, particularly Antibody-Drug Conjugates, to internal and...
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Tech Management Lead
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Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitJob Title: Tech Management Lead - Drug SubstanceAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With a strong commitment to inclusion and diversity, we foster a culture of mutual respect and continuous learning.Job...
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Tech Management Lead
vor 2 Wochen
Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe VollzeitJob Title: Tech Management Lead - Drug SubstanceAbout Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve patients' lives. With a strong commitment to inclusion and diversity, we foster a culture of mutual respect and continuous learning.Job...
Process Development Lead
vor 2 Monaten
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.
- 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.
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.
