6 months ago
*The individual will support the execution various CMO operations and manufacturing projects related to clinical pipeline programs (mainly in EU).
oThe role will involve ensuring the CMO for both cell therapy and vector manufacturing is able to meet clinical trial, program schedule and CMC objectives.
*Role will work with the CMO to ensure operational timeliness for the delivery of autologous cell therapies and vector lots.
*Support technology transfer activities as well as other CMC activities such as process changes, process monitoring and validation activities.
*The individual will organize and coordinate various activities amongst the technical functions including:
oEnsures necessary communication/information transfer within the technical team and CMO project team.
oServe as the regular person-in-plant (extension of the MSAT team) to ensure quality and operational requirements for GMP manufacturing of cell therapies/vectors are maintained.
oSupport investigations and operations issues that may arise from time to time including process and analytical issues.
oSupports the CMO technical team to investigate any project challenges with necessary risk assessment tools and techniques, leading to the implementation of corrective measures.
oSupport the implementation of assay and process changes during the clinical program.
oSupport project progression to ensure projects are completed on schedule and within budget.
*Degree/ Diploma in Biotechnology/Engineering or any related field with at least 8years of relevant working experience in manufacturing support and GMP operations
*Technology transfer experience and experience working with contract organization and vendors a must.
*Proactive in working on solving issues and problems
*Able to communicate with impact, ensuring alignment and negotiating positive outcomes from various stakeholders.
*Experience in cell and gene therapies a plus.
*Comfortable for working in a dynamic start-up environment and working remotely
*Comply to safety practices and standard operating procedures
*Travelling up to 40% to CMO site
*French speaking is a plus