1 192 offres d'emploi dans Pharmaceutique / Biotechnologie / Chimie

Engineer in Upstream Process (USP)

10.04. | Employé | 100%

Engineer in Upstream Process (USP)

Kelly Scientific is looking for an Engineer in Upstram Process (USP) for its biotech partner based in the Vaud canton.
(Permanent position)

Missions:

  • You will be responsible for the transfer of Upstream manufacturing processes from Development to internal or external GMP manufacturing facilities
  • You will also be responsible for as the management and scientific support of CMOs/CROs for GMP manufacturing of Phase I, Phase II and Phase III clinical trial supply of the company portfolio


Responsibilities:

  • Provide expertise to support the selection process of Drug Substance CMOs
  • Interact with CMOs for Drug Substance manufacturing during different phases of product development.
  • Lead the technology transfer of Upstream processes from Process Sciences to Ichnos manufacturing team, and external CMOs for Phase I, Phase II and Phase III production.
  • Evaluate Upstream process development studies and make recommendations based on their applicability to the company projects
  • Manage externalized process developments in the area of Upstream process in collaboration with Process Sciences
  • Collaborate with Process Sciences and provide input to ensure transferability to early (Phase I, Phase II) and late stage manufacturing activities (Phase III and BLA)
  • Provide documentation and operational input to facilitate IMP management for clinical trials.
  • Lead process improvement and process characterization of the company late Upstream processes, in collaboration with Process Development
  • Collaborate with the CMC project leaders in the planning and organization of tech transfer activities
  • Interpret and report results of work carried out in written and oral format both internally and externally.
  • Perform technology watch in the field of upstream production processes and monitor innovative technology development

Profile:

  • Master's degree with 3-5 years of relevant industry experience or PhD with 1-3 years of experience in biotechnology, chemical engineering or related discipline
  • Experience in scale up, technology transfer and management of upstream processes
  • Proven cell culture experience, including hands-on experience with large scale (200L and beyond) disposable or stainless steel bioreactors
  • Experience with monoclonal antibodies
  • Knowledge of process control methods and process validation principles
  • Strong knowledge of GMP
  • Excellent planning and organization skills
  • Exposure to the principles of QBD (Quality By Design)
  • Ability to manage a team in a matrix organization
  • Fluency in English, both written and verbal; French is a plus
  • Must be available to travel abroad several weeks per year


Your contact at Kelly:
Mrs Karine Legerot
Consultant Professional Staffing Life Science
Kelly Scientific Geneva