Operations Lead Biotech NPI

2 weeks ago

Dublin, Dublin City, Ireland TN Ireland Full time

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Operations Lead Biotech NPI - Dun Laoghaire, Dublin

Employment Type: Contract

Experience: 3+ years

Visa: EU passport or Stamp 4 visa required

About the Role:

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.

This is an excellent opportunity to gain experience in Ireland's leading aseptic manufacturing plant.

The Operations Lead will serve as the primary production process owner responsible for New Product 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.

The Operations Lead will be the point of contact for coordinating the manufacturing effort and will be responsible for driving process efficiencies as part of the project for operations.

They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to ensure streamlined manufacturing operations in both vial and syringe facilities.

This role is primarily based on-site in Dun Laoghaire.

Key Responsibilities:

  1. Function as the site interface between the Product Delivery Teams (PDTs) and ADL Manufacturing operations.
  2. 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.
  3. Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling, and Inspection.
  4. Develop, review, and update Production, Engineering, Operating Procedures & training materials.
  5. Assist in providing training on scientific or technical aspects of the current process/project(s) to Direct Manufacturing.
  6. Evaluate, plan, and implement solutions for process improvement opportunities both current and project-related.
  7. 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.
  8. Provide troubleshooting support throughout the project and on the floor during execution of activities.
  9. Hold people accountable for delivery and behaviors within the Manufacturing Support team and associated with the projects.
  10. Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing.
  11. Partner with Learning & Performance to define training strategies for current processes, NPIs, and complex projects.
  12. Consult with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch documentation, and licenses.
  13. Develop, review, and update Protocols for manufacturing activities.
  14. Document and approve protocol deviations for manufacturing activities.
  15. Consult with Process Development, Direct Manufacturing, Equipment, and System Owners regarding process changes in an effective and timely manner.
  16. Own and lead change controls as required by the Manufacturing support team.
  17. Review and approve Bills of Materials.
  18. Develop, review, and update Product Quality Risk Assessments.

Requirements:

  1. 3+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry.
  2. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
  3. Strong Project Management and organizational skills, including the ability to follow assignments through to completion.
  4. Critical thinking skills: Gathers data from key stakeholders, analyzes and interprets information to develop solutions to technical problems of moderate complexity.
  5. Negotiation and influencing skills.
  6. Initiative to identify and drive improvements.
  7. Excellent verbal and written communication skills: Strong technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good presentation skills.
  8. Ability to escalate issues professionally and in a timely manner.
  9. Decision-making skills and confidence to challenge others on decisions that impact the manufacturing area.
  10. Teamwork and coaching others.
  11. Ensures compliance within a regulatory environment.
  12. Demonstrated ability to work independently and deliver right first-time results under minimal direction.

Package:

Contract role - Hourly rate €35 - €45 per hour, 20% shift premium. Minimum 12-month contract with the possibility of an extension.

Shift Patterns & On-Call Opportunities:

Currently, there are a lot of PPQ activities coming up due to the new vial line. Volunteers will be asked for a 3-to-4-week period for the PPQs.

Volunteers will be needed to go on the two-cycle shift pattern. If not going on the shift pattern, on-call availability for weekends will be required.

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:

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.

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