LSC have a great contract opportunity for a Packaging Launch Specialist 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:
- Co-ordinating and managing new and existing market launches (approx. 50-60 per year)
- Site representative at global launch forums, ensuring adherence to product launch plans and the production schedule.??
- Lead and demonstrate strong stakeholder management in terms of interfacing with other departments and global teams (Material Operations, Capital Projects, Process Engineering, Quality, Packaging Development, Product Artwork Team, MES,)
- Implement a launch management process, utilizing six sigma tools to identify opportunities for improvement.
- Support and partner closely with peer groups to ensure master batch records, SOPs, training records and other documents are current and compliant under cGMP conditions - ensure Manufacturing systems and practices are consistent throughout the organization.
- Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- At least 3-5 years' experience in a regulated manufacturing environment with excellent knowledge of packaging operations
- Proven project management experience with track record of delivering projects to tight schedules.
- Strong demonstrated ability in the area of communication and strong ability to interact across cross-functional.
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 opportunity!
