external manufacturing technical lead (h/f) in Bulle

posted
contact
Kian Razavi, Randstad Inhouse Services UCB Bulle
job type
temporary
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job details

posted
location
bulle, fribourg
sector
life sciences
job type
temporary
reference number
209836-81
contact
kian razavi, randstad inhouse services ucb bulle
phone
079 515 13 46

job description

Do you have a Talent that rewards Patients? Because every single employee in UCB does! For this position we are searching for a highly experimented person as External Manufacturing Technical Lead to start ASAP (or to be discussed) for a 1 year mission:

Mission:

  • Interact with Biological Contract Manufacturers (CMO, internal production sites) in order to supply biological Drug Substances in the required quality, quantity and timing.
  • Ensure efficient Operational interaction with CMOs producing UCB Drug Substances for a late-stage development product
  • Perform regular risk analysis of the CMOs as internal UCB procedures and guaranty that the projects are on track according to agreed timelines
  • You are responsible of the Product Lifecycle Management (Tech Transfer, modification of manufacturing processes) and the documentation
  • Guaranty the coordination of technical information within External Manufacturing Operations Bio DS team.

qualification

Your profile:

  • You have a degree in biotech/pharma/chemicals or any other relevant Life Sciences field
  • You have +10 years of experience in biotech manufacturing, CMC or QA roles
  • Successfully demonstrated ability to manage, organize and track projects
  • Experience in interacting with external partners and leading outsourced activities
  • Skilled at writing and reviewing technical documentation, including cGMP documents and regulatory submissions relating to biological products
  • Fluent in English in oral and in written and French is a plus

we can offer you a new challenge in a diverse and innovative environment. Have we sparked your interest? Then we look forward to receiving your online application.