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