LSC have a great contract opportunity for Technical Specialist (Materials Science) to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Identify, lead, and implement harmonization, optimization, and continuous improvement initiatives and/or projects with an emphasis on single use items and technologies
- Assess raw material supplier change notifications, complaints, etc.
- Evaluate and/or test the feasibility of new manufacturing raw materials
- Responsible for technical evaluation of proposed raw material changes to Manufacturing processes
- Support technology and process transfer to and from the Manufacturing areas or facilities to ensure developing processes align with established large-scale and/or Commercial Manufacturing raw materials and practices
- Manage raw material change requests, CAPAs, and Action Items via Veeva QMS
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- BS in Life Sciences with 3-5 years of relevant experience in Material Science, Biopharmaceutical Manufacturing, Manufacturing Sciences and Technology, and/or Process Development.
- Strong knowledge of and expertise of pharmaceutical single use raw materials (bags, filters, tubing assemblies, drug product materials, chemicals, media, resin)
- Basic understanding of biopharmaceutical processes and raw materials used to support manufacturing operations
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 Adam Murphy at LSC on 021-4777329 if you have any more questions about this opportunity!
