- Entry level
- No Education
- Salary to negotiate
JobTitle Cell Culture Specialist 28900A
About Company Our client based in Dun Laoghaire is seeking aCell Culture Specialist to join its expanding team
Duration of Role 12 months
Summary Objective Provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure Amgen Contract Manufacturing (ACM) work cell (hub) success.
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.Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.
Site performance monitoring: Report contract site performance metrics to site lead; 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 used by the Work Center Teams (WCT),oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.
Requirements no visa processing Basic Qualifications:
• Bachelor’s in Business Administration, Engineering or Science-related field
• 5years of experience in protein, API, DS, DP or packaging manufacturing environment (Preference is Drug Product)
• 5years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
• 2years of project management experience leading multi-functional and/or multi-location team
• 1years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products
BenefitsBenefits of working with Independent Solutions
Excellent Team of Colleagues
Access to high-value projects
Excellent Technical Project Managers
Excellent pay & conditions
Independent Solutions are Approved Suppliers for Multinational Pharma Biotech, Medical Device, clients with locations based here in Ireland.
At Independent Solutions, we will not require you to become an employee of Independent Solutions, we will facilitate and support you to become an independent contractor, thereby reaping the maximum rewards from your contract role.
We work in the area, we know the business, we are not a recruitment agency!
We continue to partner and grow our client base and thereby ensure that we have continuous supply of excellent roles
Yes, of course we benefit from having YOU with US, but we can assure YOU that YOU too will benefit …
- business administration
- ms project