Kelly Services are currently recruiting a Cell Specialist (Contract Manufacturing) for our Global Biopharmaceutical client in Co. Dublin.
This an 18 month contract initially with an excellent rate on offer.
· Provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure Contract Manufacturing work cell (hub) success. Site performance monitoring: Report contract site performance metrics to site lead.
· Manufacturing operations: 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) etc.
· Identify improvement opportunities for site performance.
· Daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools.
· Oversight and reporting of procurement/payment of invoices, and active participation in meetings with the contract site as well as internal site team.
· Project Management and Technology 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; provide escalation to the right level.
· Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.
Knowledge, Experience and Skills
* 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
* Demonstrated matrix management and influencing skills.
* Manufacturing and cGMP knowledge / experience.
* Demonstrated negotiation skills.
* Operational Excellence proficiency and ability to drive continuous improvement.
* Financial/budgeting knowledge and business acumen.
* Proficient in project management
* Problem-solving and critical thinking.
* Understanding of contractual requirements.
* Technical writing and multi-level communication skills.
* Demonstrated ability to lead effectively in collaborative/team environment.
* Demonstrated ability to take initiative, drive action, and work under minimum supervision.
Please apply today or contact Niall Curley on 086-4113572 for more information.
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.