Global Dengue Vaccine Analytical LCM Lead

Takeda

Linz

On-site

EUR 191,000 - 263,000

Full time

7 days ago
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Job summary

Takeda is seeking a global Dengue vaccine Analytical LCM Lead in a senior, cross-functional role. You will own the analytical lifecycle, ensuring robust control strategies and proactive planning across development and commercialization.

You will collaborate with QA, QC, Regulatory, IT, and manufacturing teams to align strategies, drive risk-based approaches, and propel digital analytics innovations within the LCM program.

Qualifications

  • BS/MS in Microbiology, Virology, Immunology, Biochemistry, Biology, or related discipline (PhD preferred).
  • 10+ years in pharma/biotech with depth in Analytical Development and/or QC, leading vaccine analytical programs; experience with live-attenuated vaccines.
  • Experience developing analytical control strategies and supporting regulatory submissions (IND/IMPD/BLA/NDA/MAA).
  • AQbD, validation/verification, robustness, and lifecycle management knowledge.
  • Strong scientific leadership and stakeholder management across functions.

Responsibilities

  • Single point of accountability for the global Analytical LCM of Dengue vaccine (live-attenuated tetravalent).
  • Owns the Dengue vaccine Analytical LCM Strategy and Roadmap across the lifecycle, with clear roles and resource planning.
  • Collaborates with MSAT, QC labs, Regulatory CMC, QA, and IT to align plans and resources.
  • Drive analytical technology innovation and platform modernization within the Dengue vaccine LCM program.
  • Embed risk-based thinking in method development, qualification/validation, and tech transfer to improve robustness and efficiency.

Skills

Analytical leadership
Regulatory submissions
Vaccine analytics

Education

BS in Microbiology
MS in Immunology

Tools

CDS
LIMS
ELN

Job description

Takeda is seeking a global Dengue vaccine Analytical LCM Lead in a senior, cross-functional role. You will own the analytical lifecycle, ensuring robust control strategies and proactive planning across development and commercialization.

You will collaborate with QA, QC, Regulatory, IT, and manufacturing teams to align strategies, drive risk-based approaches, and propel digital analytics innovations within the LCM program.

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