LSC have a great contract opportunity for a Senior Technical Specialist to join a biopharmaceutical company based in Dublin. The company is focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
The Senior Specialist Technical Services is responsible for providing technical support of commercial and clinical drug substance and drug product manufacturing operations performed at contract manufacturing organisations (CMOs). The successful candidate will be responsible for providing scientific and engineering support through all phases of the product lifecycle, including technology transfer, process scale-up, process validation and routine commercial or clinical manufacturing.
0 Provide significant technical expertise to support all aspects of the manufacturing of commercial and late stage clinical biopharmaceutical products at CMOs or internally.
0 Lead troubleshooting efforts and high-level deviation investigations in conjunction with CMOs and internal partners (Process Development, Manufacturing, Quality, etc.)
0 Support all aspects of the manufacturing process from raw material selection and specification through upstream manufacture, downstream processing, testing and release.
0 Technical review of change controls for impact to product quality, safety and efficacy.
0 Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated at CMOs.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
0 Minimum of five years’ experience in providing technical support to biologics drug substance manufacturing or a strong operations role
0 Extensive knowledge of biologics manufacture, mammalian cell culture and purification unit operations.
0 Experience of technology transfers and scale-up.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
To apply, submit your CV via this advert or contact Aaron Kingston at LSC on 021-4777329 if you have anymore questions about this opportunity!