DA
Daiichi Sankyo
12 Tage

Senior Tech Management Lead Drug Product(m/w/x)

Vollzeit
Senior
Keine Angabe
Pfaffenhofen an der Ilm

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

Englischverhandlungssicher

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