Our client, a global biopharmaceutical leader, are seeking a driven Work Cell Specialist to provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure work cell/CMO success.
If you have a background in Quality, Tech Services, Tech Ops, MS&T, Process Development, or Manufacturing Science and have an interest in leading an innovative and data-driven continuous improvement project, this could be a good fit for you.
- Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting
- Inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) et
- Own NC Class II/III records, CAPA, CAPA EV, and more complex change control record
Project Management & Tech Transfers:
- 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
Site Performance Monitoring:
- Report contract site performance metrics to site lead
- Identify improvement opportunities for site performance.
- Conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by relevant teams.
- Active participation in team meetings with the contract site as well as internal site team.
You will have skills and experience in the following:
- Minimum BSc in Science or Engineering related discipline.
- 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.
- Project management experience leading multi-functional and/or multi-location team.
- Demonstrated negotiation skills.
- Operational Excellence proficiency and ability to drive continuous improvement.
- Financial/budgeting knowledge and business acumen.
- Proficient project management skills.
- Demonstrated ability to lead effectively in collaborative/team environment.
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.