Vaccine Manufacturing Lead

at  CEPI

Oslo, Oslo, Norway -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate21 Jan, 2025Not Specified22 Oct, 2024N/ASupply,Norway,Testing,Biochemical Engineering,Regulatory Agencies,Communication Skills,Due Diligence,Regulatory Compliance,Technology TransferNoNo
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Description:

EDUCATION, EXPERIENCE AND COMPETENCE

  • Master’s degree &/or PhD in Biochemical Engineering, Biological/Pharmaceutical sciences, or another relevant discipline.
  • At least 10-years’ experience in the vaccines industry, consulting or in an NGO (e.g. WHO) is essential - public health sector acceptable, biologics experience considered.
  • Demonstrated leadership of diverse teams to integrate technical, quality, regulatory compliance, and operational elements towards managing vaccine manufacturing site readiness.
  • Expertise across vaccine development, (drug substance/product) manufacture, testing, formulation, fill, release and supply for clinical trial or commercial use preferably within LMIC regions.
  • Expertise in biopharma organisation, evaluation, technology transfer and facility due diligence.
  • Managing licensed third party CDMO relationships.
  • Experience working across cultures and countries is preferred.
  • Prior interactions with National Regulatory Agencies considered advantageous.
  • Fluency in verbal-written English is a must and exceptional communication skills are required.

TRAVEL AND LOCATION REQUIREMENTS

  • This position can be based in the UK, US or Norway.Travel to other countries &/or regions is estimated to require
  • 20% of time.

Responsibilities:

ABOUT THE ROLE

CEPI is currently looking for a Vaccine Manufacturing Lead to join the Manufacturing & Supply Chain (MSC) division within the Manufacturing & Supply Chain Networks team.
Objectives
1. Deliver activities that help secure operational sustainability across the CEPI Vaccine Manufacturing Facility Network (VMFN) supporting CEPI’s projects with agile, robust, rapid equitable access solutions for vaccine production in Global South/LMIC regions.
2. Work with VMFN organisations to enable their outbreak response preparedness and future supply of CEPI vaccines portfolio to emerging disease threats leveraging novel platforms/innovations to reach the CEPI 100DM, in collaboration with global stakeholders and partners.

RESPONSIBILITIES

  • Lead vaccine manufacturing operational sustainability project activities with CEPI VMFN organisations in LatAm and Caribbean, Africa, M. East, S.E. Asia &/or W. Pacific.
  • Drive scientific-technical-manufacturing programs to achieve future sustainability across a range of vaccine platforms supporting productivity, quality, and equitable supply in Global South/LMIC regions.
  • Manage collaborative relationships with international partners, providing input to execute and maintain vaccine manufacture sustainability deliverables with CEPI VMFN organisations in each region.
  • Support CEPI VMFN due diligence processes and site-visits/meetings.
  • Engage with local and international organisations e.g., RVMC, WHO, PAHO, Africa-CDC, ASEAN to advance CEPI vaccine manufacturing sustainability deliverables with each facility.
  • Play a key role in defining and delivering long-term strategic goals with VMFN organisations and partners within each region – coordinating activities across CEPI internal teams and external partners, collaborators, and stakeholders.


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

IT Software - Other

Clinical Pharmacy

Graduate

Biochemical engineering biological/pharmaceutical sciences or another relevant discipline

Proficient

1

Oslo, Norway