Daiichi Sankyo
Tech Management Lead - Drug Substance(m/w/x)
Vollzeit
Senior
Keine Angabe
Pfaffenhofen an der Ilm
DA
Daiichi Sankyo1 Monat
Senior Tech Management Lead Drug Product(m/w/x)
Vollzeit
Senior
Keine Angabe
85276 Pfaffenhofen an der Ilm
Nejo KI-Zusammenfassung
In this role, you will lead the technology transfer of drug manufacturing processes, ensuring alignment across multiple sites. Your day-to-day responsibilities will involve coordinating teams, reviewing technical documents, and driving strategic recommendations to enhance site performance.
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Anforderungen
- •Ph.D. in biochemistry, chemistry, pharmaceutics, engineering, or related disciplines, or master's degree with equivalent work experience
- •Multiple years of experience in pharmaceutical/biotechnology industry in drug development
- •Extensive experience in CMC related functions including solid formulation and/or sterile and lyophilized process development
- •Excellent knowledge of CMC development, process development, technology transfer, CMC regulatory, and GMP compliance
- •Creativity and demonstrated track record of success in drug development, tech transfer, and validation
- •Strong verbal and written communication skills in English and ability to interface effectively with multi-national teams
- •Leadership of global project and cross-functional working teams
- •Ability to influence outcomes by negotiating win-win solutions and resolving conflict
- •Strong problem solving and risk-based decision-making skills
- •Leadership of programs with global reach and high priority
- •Ability to develop and implement long-term vision for Technology Transfer of Drug Product processes
Doktor / Ph.D.
ODER
Master-Abschluss
Berufserfahrung
ca. 4 – 6 Jahre
Deine Aufgaben
- •Lead and coordinate Site Launch activities for internal and external sites
- •Drive program strategy for complex supply chains with multiple manufacturing sites
- •Act as the main interface for internal and external sites
- •Review technical documentation related to manufacturing and tech transfer
- •Manage scouting activities and recommend CDMOs for site selection
- •Create and implement technology transfer and manufacturing plans
- •Communicate outcomes of key meetings to stakeholders
- •Drive technical recommendations for future site selections
- •Collect and share key data to improve Drug Product site performance
- •Conduct data review and support data transfer to repositories
- •Recommend remediations and provide inspection support to mitigate risks
- •Participate in CMC working group meetings and provide updates on tech transfers
- •Support technical review of CMC sections for regulatory submissions
- •Coordinate with lab units and other functions to solve issues
- •Establish and maintain relationships with internal and external stakeholders
Sprachen
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Daiichi Sankyo erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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