CMO and CTL Operation Manager

Posted 12 November 2021
Job type Limited
DisciplineLife Sciences

Job description

For its pharmaceutical partner, Kelly Scientific is looking for a:

CMO and CTL Operations Manager

(1 year temporary contract - could extended)

Your mission:

  • You will ensures successful manufacture of cell therapy materials and performance within our external network
  • You will work with Contract Manufacturing Organizations (CMOs), and Contract Testing Labs (CTLs), with a focus on understanding the risk to quality, yield, and timelines from the technical implementation and/or execution of our client processes at remote CMO sites

Your responsibilities:

  • Supports operational oversight of CMO management, ensuring compliant, efficient, and timely production and delivery of products.
  • Manages a portfolio of cross-functional external manufacturing projects with focus on developing and maintaining overall project plan objectives and timelines. May act as project manager or serve on a project team. Ensures smooth execution of manufacturing-related projects and process improvements, acting as a resource for both CMO and our client stakeholders.
  • Support the CMO relationship manager in managing the CMO, including logistics, batch scheduling and tracking. Track internal change controls, deviations, and corrective actions as part of our client internal processes.
  • Manages and tracks CMO performance through data analysis and monitoring of KPIs for CMO performance, meeting administration and engagement. Maintains action trackers, Share Point forms and risk registers. May perform data analytics.
  • Support tracking of change controls, deviations, and corrective actions as part of our client internal processes.

Your profile:

  • Bachelor or Master in Life Sciences, Chemistry or equivalent
  • Minimum of 3-5 years of relevant experience
  • Ideally experience in commercial or clinical manufacturing of cell therapy materials or biologics
  • Experience in project management and data management highly preferred.
  • Excellent problem-solving skills and ability to work effectively with multiple assignments
  • English fluent, another language would be a plus

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