Purpose
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 projects.
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 processes and collaborate 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.
* Assist in providing training on scientific or technical aspects of current processes/project(s) to Direct Manufacturing.
* Evaluate, plan, and implement solutions for process improvement opportunities both current and project-related.
* Support scheduling and execution of Characterisation, Engineering, and PPQ runs, ensuring all necessary pre-requisites are included on the schedule and assess process performance by observation of floor operations and review of performance data.
* Provide troubleshooting support throughout the project and on the floor during execution of activities.
* Hold people to account for delivery and behaviors within the Manufacturing Support team and associated with the project(s).
* Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing.
* Partner with Learning & Performance to define training strategies for current processes, NPIs, and complex projects.
* Consult with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch documentation, and licenses.
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.
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), 2-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, so if on morning shift week 1 then on evening shift week 2 and so on.
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 Compensation is as per the on-call policy.