Tech Transfer Lead - 12 months contract
SRG are a strategic recruitment partner to a global diagnostics company who are looking Tech Transfer Lead to be based in Dublin area.
- This role will require the candidate to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes at ADL.
- Leads new product introductions to ADL PM2 and PM3 from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer to PM2 or PM3.
- Provide solutions when trouble shooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection and transportation for parenteral products through the NPI or post-NPI phases
- Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation.
- Third level Bachelor's degree in science, engineering or a relevant quality discipline with 5 years experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Prroduct development, process/product design, develops and characterizes drug product processes experience is a must.
#techtransfer #productdevelopment #drugproducts #cGMPs #engineering
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