LSC have a great contract opportunity for a Sr Project Manager to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
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!
KEY RESPONSIBILITIES:
- Project Management and Technology transfers: The role involves leading and managing new product introductions (NPI) and technology transfers to external (third party) manufacturing organisations. This includes coordinating cross-functional teams, ensuring adherence to business processes, and overseeing multiple complex projects. Responsibilities also cover project planning, budgeting, communication, and reporting, as well as driving continuous improvement initiatives to enhance quality, efficiency, and alignment with company priorities.
- Follow-up and track activities in a department-wide project from conception to implementation and close-out.
- Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.
- Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; contract inputs and requirements, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.
- Own Deviations (Major/Minor). Maintain and monitor systems to ensure all deviations received are appropriately investigated and concluded per the company's quality standards and procedures.
- Optimise deviations management, corrective and preventive actions effectiveness to prevent reoccurring events. Own SICAR | CAPA | CAPA EV and more complex change control records.
ABOUT YOU
- Bachelor's in Business Administration, Engineering or Science-related field
- 5+ years of experience in protein, API, DS, DP or packaging manufacturing environment
- 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
- 2+ years of project management experience leading multi-functional and/or multi-location team
- 1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
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 Brian Garvey on 021 4777329 if you have anymore questions about this role!
