Operational Lead

21 hours ago

Dublin, Ireland Team Horizon Full time

Team Horizon is seeking an Operational Lead to serve as the primary production process owner responsible for New Production Introduction, life cycle management projects, CAPEX projects, and established process improvement projects. 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.

Why you should apply:

- This is an excellent opportunity to join a world-class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering from serious illnesses.
- There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically enhance people’s lives.
- Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply as they expand internationally.

What you will be doing:

- Function as the site interface between the 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 material.
- 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.
- 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 accountable 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 on 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.
- Develop, review, and update Protocols for manufacturing activities.
- Document and approve protocol deviations for manufacturing activities.
- Consult with Process Development, Direct Manufacturing, Equipment, and System Owners regarding process changes in an effective and timely manner.
- Own and lead change controls as required by the Manufacturing support team.
- Review and approve Bills of Material.
- Develop, review, and update Product Quality Risk Assessments.

What you need to apply:

- 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.
- Strong Project Management and organizational skills, including the ability to follow assignments through to completion.
- Critical thinking skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexity.
- Negotiation and influencing skills.
- Take initiative to identify and drive improvements.
- Excellent verbal and written communication skills: Strong technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good presentation skills.
- Escalate issues professionally and in a timely manner.
- Decision-making skills and confidence to challenge others on decisions that impact the manufacturing area.
- Teamwork and coaching others.
- Ensures compliance within a regulatory environment.
- Demonstrated ability to work independently and deliver right-first-time results under minimal direction.

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