LSC have a great contract opportunity for a Senior Specialist, Drug Substance 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 5 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Providing technical and scientific direction for ongoing commercial drug substance manufacture at CMOs.
- Provide technical direction for the identification and implementation of process optimization initiatives as well as efficiency and capacity improvements at CMOs, using AI tools where applicable.
- Oversee process monitoring and statistical analysis of commercial external manufacturing activities (continued process verification).
- Support the generation and review of CMC sections of the NDA/MAA and other technical documents for regulatory agency submission for commercial CMO sites
- Communicate operational status of CMOs regularly to management, as required, at the appropriate level of detail. Communication will be both written documents, and in formal and informal oral presentations.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum of 5 years' experience in a technical or manufacturing role in the pharmaceutical industry with a major focus on drug substance (DS).
- Broad experience of technology transfer, process validation management, and continuous improvement.
- Knowledge of drug substance upstream and downstream unit 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 Cian Marnane at LSC on 021 4777329 if you have any more questions about this role!
