22 days ago

Manufacturing Project Leader

Kelly Scientific Resources Genève

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Manufacturing Project Leader


Kelly Scientific is looking for a Manufacturing Project Leader

Job Overview:
Our client is seeking an experienced Manufacturing Project Leader to support its product development programs. The Manufacturing Project Leader will lead the development and implementation of manufacturing processes for the production of new biological entities (NBE) either in-house and/or with external partners (CMO) to timely deliver the required quantities of material for preclinical and/or clinical studies.
 
 
Key Responsibilities:

  • Lead and coordinate the development, manufacturing and distribution of NBE, from Drug Substance synthesis to Investigational Medicinal Product distribution to Clinical Sites.
  • The activities typically encompass CMC project management, process development, process scale-up, industrialization and manufacturing (non-GMP and GMP) both in-house and at CMOs.
 
Qualifications: 
  • At least 5 years of experience in CMC project management in the pharmaceutical industry which should cover:
    • Demonstrated ability to plan, coordinate and complete complex
    • CMC projects within agreed budgets and timelines
    • Demonstrated ability to lead a process development and manufacturing project to success and timely deliver related milestones
    • Experience in formulation development and/or clinical production and supply would be an asset
    • Experience in Vaccines and Small molecules would be an additional asset
  • At least 3 years of experience in Process Development, Small-scale
  • Production, Scale-up and GMP manufacturing
  • Personal features include:
    • Ability to communicate clearly and efficiently at all levels, within
    • the company and with external partners
    • Ability to integrate and learn fast
    • Self-motivating
    • Team player
    • Fluency in English is a must; French and a third language are assets
Your contact at Kelly Scientific:
Karine Legerot
Engineer in Biotechnology
Consultant Professional Staffing Life Science