LSC have a great contract opportunity for a Technical Service Manager 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 6 years' experience in the pharmaceutical industry and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Provide guidance to process validation program for OSD manufacturing processes at CMOs. Provide technical input to process development for defining the critical process parameters of new processes.
- Provide technical direction for the identification and implementation of process optimization initiatives as well as efficiency and capacity improvements at CMOs.
- Communicate operational status of CMOs regularly to management, as required, at the appropriate level of detail. Communications will be both written documents, and in formal and informal oral presentations.
- Support the generation and review of CMC sections of NDA and other technical documents for regulatory agency submission for commercial CMO sites.
- Provide significant technical depth to support continuous process improvement to maximize yield and lower cost of goods (CoGs).
- Up to 20% international travel may be required.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Demonstrated ability to project manage technology transfer and/or new product launches.
- Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
- An advanced degree (MS, PhD) is desirable.
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 Pawel Jurkiewicz at 0214777329 at LSC on 021-4777329 if you have anymore questions about this.