Tech Transfer Lead in Dun Laoghaire, Ireland
CK Group are recruiting for a Tech Transfer Lead (Senior) to join a global Bio-tech in Dun Laoghaire. The role will be offered on a 12 month contract initially and is full time.
The Company: Our client is one of the worlds leading manufacturers of biosimilar and biopharmaceutical products used in the treatment of a wide range of human healthcare conditions from cancer to arthritis. This company are a strong believer in helping patients by developing new treatments and taking them to market via their global network of specialist aseptic manufacturing, packaging and distribution sites.
The Location: This role is located on a state of the art manufacturing facility based in Dun Laoghaire and is a quick 30 minute drive away from the centre of Dublin, or 60 minutes drive from Dublin Airport. The site is easily commutable from Kildare or Wicklow by car and there is a good public transport network if you would prefer to live within Dublin itself. Dun Laoghaire is a vibrant cultural hub in south Dublin which is best known for its maritime history and locally caught sea food.
The Tech Transfer Lead will provide process development support primarily to new product introductions and lifecycle management changes. The candidate will establish themselves in a product lead role where the majority of input provided will be the leading of process performance qualification. In addition, the candidate will be expected to provide technical support to biologics drug product manufacturing as part of the global Process Development organisation.
Responsibilities would include the following:
- Lead new product introductions to 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.
- Be accountable for the success of the product transfer project from initiation to the transfer, through line characterisation, engineering studies, process performance qualification and ultimately to regulatory approval.
- 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.
- Support commercial drug product manufacturing operations with technical evaluation of Change Control/NC/CAPA and technology transfer.
To be considered for the role, you will be required to have the following skills, knowledge and experience:
- Bachelors degree in science, engineering or a relevant quality discipline with experience in a similar role -Experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, tech transfer (to commercial DP sites) or validation.
- Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling (PpK / batch homogeneity) and/or lyophilisation processes.
- Knowledge of protein biochemistry with regard to chemical and physical stability.
- Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
For more information or to apply for this position, please contact Jenni, Julie or Heather at CK Group on 01438 723500 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA44251 in all correspondence.