LSC have a great contract opportunity for Technical specialist to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products.
If you have a minimum 2+ years' experience in Technical Services / Process Development / Manufacturing in a biological bulk drug substance manufacturing organization and are ready for your next challenge
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Acting as technical SME to support the selection and introduction of critical raw materials and single use components
- Providing technical leadership for material/component related issues, complaints, and investigations Identifying opportunities to simplify existing manufacturing processes
- Liaising with Vendors to ensure they conduct adequate investigations and implement appropriate corrective actions when issues are identified
- Providing significant technical depth to support troubleshooting efforts and deviation investigations in conjunction with Technical Services, Operations, Engineering and Quality
- To author and review process transfer documentation, gap assessments, technical protocols and reports, and process validation documentation, strategy documents
- To identify requirements for laboratory studies to support process fit, decisions or process transfer, and to liaise closely with Global Process Development to oversee the design and execution of studies
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing
- Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings
- Ability to present and defend technical and scientific approaches in both written and verbal form
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!
Apply via this advert or contact Peter Cronin at LSC on 021-4777329 if you have any more questions about this role!