Biotech Tech Transfer Lead

Biotech Tech Transfer Lead - NPI - Hybrid

Office/Project Location:Dun Laoghaire, Dublin

Employment Type: Contract

Work Location: Hybrid

Pay: €45 - 55 per hour

Experience: 5+ years

Visa: EU passport or Stamp 4 visa required

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.

Overview

This role will require you to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes. 

In addition, you will be expected to provide technical support to biologics drug product manufacturing as part of the global Process Development organization.

Supports new product introductions from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer.

Be accountable for success of the product transfer project from initiation to the transfer, through line characterisation, engineering studies, process performance qualification and ultimately to regulatory approval.

Provide solutions when trouble shooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection and transportation for parenteral products through the NPI or post-NPI phases.

Provide process development knowledge for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation. 

Support commercial drug product manufacturing operations with technical evaluation of Change Control/NC/CAPA and technology transfer.

The position will report to Process Development Senior Engineer. 

Moderate international travel might be required during the course of the project.

Development of validation plans, process performance qualifications for vial and syringe filling.

Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.

Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related to technology transfer.

Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones.

Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.

Actively communicates across functions and sites and is a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions.

Act as the responsible point contact from site for the transfer project for drug product teams and Global Operations Teams.

Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations and input to site validation guidance documents.

Collate and report on relevant shipping and filter validation.

Assist in deviation and exception resolution and root cause analysis.

Contribute to product quality assessments and process flow documents.

Requirements

Third level Bachelor's degree in science, engineering or a relevant quality discipline with 5 years experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience.

Knowledge of cGMPs and other worldwide regulatory requirements.

Problem solving ability and excellent oral and written communications skills.

Preferred Qualifications

Doctorate or Masters in Science or Engineering.

Experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, tech transfer (to commercial DP sites) or validation.

Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling (PpK / batch homogeneity) and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability.

Project management skills including the ability to manage multiple projects and evaluate project resource requirements.

Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.

Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skills are essential for this role.

Package

Contract role - Hourly rate €45 - €55 per hour / €67.50 shift rate when required.

Minimum 12 month contract with the strong possibility of an extension. 

Onsite Requirements: Initially, we'd expect a presence on-site three days a week to cover events and tasks, with increased flexibility as you become more adept in the role.

Shift Details: Predominantly normal working hours, with a 35% shift commitment. 

Be prepared for occasional shift work due to upcoming NPIs and LCMs.

The successful candidate will need to be prepared to participate in 24/7 support once or twice a quarter (depending on business needs) for approx. 

1-2 weeks at a time. 35% shift rate applies.

Confirmed shift pattern: Its 2 days on 7am-7pm, 2 nights on 7pm-7am, 4 days off.

Moderate international travel might be required during the course of the project.