Daiichi Sankyo
Senior Tech Management Lead Drug Product(m/w/x)
Vollzeit
Senior
Keine Angabe
Pfaffenhofen an der Ilm
DA
Daiichi Sankyo1 Monat
Tech Management Lead - Drug Substance(m/w/x)
Vollzeit
Senior
Keine Angabe
85276 Pfaffenhofen an der Ilm
Nejo KI-Zusammenfassung
As a Tech Management Lead for Drug Substance, you will oversee technology transfer processes for drug manufacturing, ensuring smooth transitions and collaboration across teams. This role involves leading site launch activities, reviewing technical documentation, and making data-driven recommendations to enhance manufacturing performance.
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Anforderungen
- •Ph.D. in biochemistry, chemistry, pharmaceutics, engineering, or related disciplines, or master's degree with equivalent work experience
- •Many years of experience in pharmaceutical/biotechnology industry in process development
- •Extensive experience in CMC related functions including biopharmaceutical process and product development
- •Strong knowledge of CMC development, process development, technology transfer, CMC regulatory, and GMP compliance
- •Strong verbal and written communication skills in English
- •Experience leading global project and cross-functional working teams
- •Ability to negotiate win-win solutions and resolve conflict
- •Ability to plan and organize tasks according to strategic decisions
- •Contributes to operational planning and organization of key functional processes
Doktor / Ph.D.
ODER
Master-Abschluss
Berufserfahrung
ca. 4 – 6 Jahre
Deine Aufgaben
- •Lead and coordinate Site Launch activities and associated teams
- •Act as the main interface for internal and external sites
- •Review technical documentation related to manufacturing and tech transfer
- •Conduct scouting activities and recommend CDMOs for site selection
- •Communicate and implement manufacturing plans aligned with CMC strategies
- •Share outcomes of key meetings with stakeholders and functional areas
- •Support technical recommendations for future site selections
- •Collect and share key data to improve drug substance manufacturing performance
- •Conduct data review and analysis for data-driven decision-making
- •Liaise between Tech Strategy and the site for data transfer
- •Recommend remediations and provide inspection support to mitigate risks
- •Participate in CMC working group meetings and provide updates on tech transfers
- •Support the compilation and review of CMC sections for regulatory submissions
- •Coordinate with lab units and other teams to drive collaboration and resolve issues
Sprachen
Englisch – verhandlungssicher
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