Operations Lead Biotech NPI

3 weeks ago

Dublin, Dublin City, Ireland JobContax Full time

Operations Lead Biotech NPI - Dun Laoghaire, Dublin

Office/Project Location: Dun Laoghaire, Dublin

Employment Type: Contract

Work Location:   Site Based

Pay:  €35 - €45 per hour

Experience: 3+ years

Visa:  EU passport or Stamp 4 visa required

Operations Lead Biotech NPI - Dun Laoghaire, Dublin

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 get experience into Ireland's leading aseptic manufacturing plant.

Operations Lead will serve as primary production process owner responsible for New Product Introduction, Life Cycle Management Projects and/or CAPEX projects and established process improvements projects. 

This role requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation and Capping.

They will be the operations point of contact for coordination of 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 are enabled in both vial and syringe facilities.

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

Function as the site interface between the Product Delivery Teams (PDT's), and ADL Manufacturing operations.

Engaging with staff members within the Manufacturing department to ensure understanding of the processes and working 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 & 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.

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 SOP's, batch documentation and licences

Develop, review and update Protocols for manufacturing activities

Documentation and approval of 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 Materials

Develop, review and update Product Quality Risk Assessments

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.

Strong Project Management and organizational skills, including 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 regulatory environment

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:

Now they have a lot of PPQ activities coming up due to the new vile line we'll be asking for volunteers for a 3-to-4-week period for the PPQ's. 

There will be volunteers to go on the two-cycle shift pattern & then the other ask is, if you're not going on the shift pattern can you do on-call for the weekends.

People required to go on a two-cycle shift pattern for the duration of each PPQ activities:

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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