We re seeking to recruit a QC Site Operations Projects Senior Specialist to support the QC Site Operations Projects team at its Multi-Product Cell Culture Drug Substance Facility.

Reporting to the QC Site Operations Projects Senior Manager, they will support the activities in the Projects team as defined below

Key Responsibilities:

• Support the QC teams with continuous improvement projects as part of the QC Projects team portfolio.
• Support of process improvements for onboarding, training plans and method specific training.
• Support of process improvements for investigation reduction and right first time in the QC teams.
• Support Lean labs and automated scheduling tool process improvements.
• Project management of projects assigned to self, including planning, tracking, communication and escalations were needed.
• Strategically plan and implement procedures and systems to maximise operating efficiency through the use of Operational Excellence tools
• Support of operational training activities to support efficiency and compliance across QCSO e.g support onboarding and other training related requests.
• Support of transfers managed by QC Projects team where needed.
• Perform activities to support Drug Substance release e.g tracking, data collation.
• Compliance with Standard Operating Procedures and Registered Specifications.
• Ensure any laboratory process improvements align with the BMS Safety culture.
• Approval of SOPs, Training documents etc where required.
• Participate in regulatory agency inspections as required.

Requirements:

• Excellent written and verbal communication skills.
• Experience of working with teams and influencing decisions.
• Experience leading cross-functional teams.
• Knowledge of applicable regulatory requirements is desirable.
• A third level qualification (Degree) in Science or related discipline.
• 6 years of experience in a pharmaceutical / healthcare laboratory or related technical function.
• A strong knowledge of laboratory operation, in particular training and testing requirements from receipt to CoA is required.
• Involvement in project scoping and tracking is desirable.

The Next Step for you:

Should this position be of interest to you please forward your CV to Nuira Esmau at Next Generation Recruitment via the Apply button. Next Generation are specialists in recruiting for roles in Data Science, Digital, Engineering & Life Sciences, IT, Supply Chain & Operation, Engineering and are in strict confidence. Next Generation will never share your data outside of our organisation without your prior written consent; all our calls are recorded for training and quality purpose. Please read our Data Protection Policy on our website.