Purpose and Scope
The Operations Lead serves as the primary production process owner responsible for New Product Introduction, Life Cycle Management Projects, CAPEX projects, and established process improvements.
This role requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes, including Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation, and Capping.
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Key Responsibilities
* Function as the site interface between Product Delivery Teams (PDTs) and ADL Manufacturing operations.
* Engage with staff members within the Manufacturing department to ensure understanding of the processes and work collaboratively cross-functionally with Facilities & Engineering, Quality, PD, and Supply Chain.
* Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling, and Inspection.
* Develop, review, and update Production, Engineering, Operating Procedures, and training materials.
* Assist in providing training on scientific or technical aspects of the current process/project(s) to Direct Manufacturing.
* Evaluate, plan, and implement solutions for process improvement opportunities both current and project-related.
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Requirements
* Bachelor's degree in a science discipline.
* 3+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry.
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
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Shift Patterns and On-call Cover
People required to go on a two-cycle shift pattern for the duration of each PPQ activity:
* 8-hour days operating over a 5-day week (Monday - Friday)
* Two-week rota
* Week 1: Morning Shift (07:00 - 15:00 Mon-Thurs), (07:00 - 14:00 Fri)
* Week 2: Evening Shift (14:30 - 22:30 Mon-Thurs), (13:30 - 20:30 Fri)
Alternating pattern. 20% shift premium applied. On-call cover for weekends from 07:00 Saturday - 19:00 Sunday (excluding nights). Rostered on-call. Must be able to attend site if required over both days.