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Position Summary
BMS Cruiserath Biologics is seeking to recruit a Manager, QA Laboratory Operations for Sterile Drug Product.
Reporting to the Senior Manager, QA Laboratory Operations, the Manager will support the start-up of a commercial drug product manufacturing facility for its biologic’s commercial portfolio and clinical pipeline and be the primary delegate for the Senior Manager. During start-up, this role will work in conjunction with the project team to provide QA oversight and support to QC start up activities, GMP operational readiness, Method Transfer and Laboratory Equipment Qualification activities.
Post start-up the successful candidate will be part of the QA Laboratory Operations team supporting routine commercial sterile drug product testing and release activities.
The start-up nature of this project will require adaptability & innovation due to the multiple project phases and multiple products onsite. The role will be both challenging & rewarding and will thus ensure that the successful candidate can seize a wide range of development opportunities within BMS. The Sterile Drug Product project scope includes construction and commissioning of new SDP product suite with parts prep, formulation, aseptic filling and capping of liquid & freeze-dried vials, aseptic filling of syringes, and Visual Inspection capabilities. The project also includes new and expanded clean utilities.
Key Responsibilities During Start Up
Provide QA oversight and support to start up activities, GMP operational readiness, Method Transfer and Equipment Qualification
Support qualification activities including QA approval of SOPs, deviations, CAPAs, change controls, risk assessments, equipment qualification documentation and method transfer documentation for QC operations.
Responsible for coaching and development of staff and direct personnel to achieve operational goals and ensure the timely completion of tasks.
Partnership with CQV and QC team in delivering the GMP scope of work associated with the startup of sterile drug product operations at Cruiserath.
Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.
Key Responsibilities During Commercial Operations
QA Laboratory Operations oversight of product testing and release activities for commercial and clinical sterile drug product
Laboratory Investigation system owner for the QC laboratories and Contract Test laboratories Manage the QC Triage business process
Laboratory Investigations SME during regulatory agency inspections
QA Laboratory Operations Lead at Investigations Review Board (IRB)
Liaising with manufacturing site and/or contract laboratory for complex investigations
QA Approver for complex/multi-functional deviations, root cause investigations, QC Laboratory investigations, impact assessments and associated CAPAs
QA Support Operational SOPs, test methods, forms and directives
Annual Product Reviews (APQRs)
Annual Trend reports
Laboratory equipment/instrument qualification protocols and reports
Method validations / technical transfers protocols and reports
Responsible for coaching and development of staff and direct personnel to achieve operational goals and ensure the timely completion of tasks.
Drive and support culture of continuous improvement initiatives and safe working practices.
Support Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem…