Technical Transfer

2 weeks ago

Dublin, Ireland Berkley Group Full time

Overview

Technical Transfer (Intermediate) – Pharmaceutical Dublin Contract Aug 1, 2025

A market-leading biopharmaceutical company based in south Dublin, Ireland – looking for Technical Transfer – (Intermediate) specialist.

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

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.

The Job

- 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 expertise 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.

- 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.

Have You

- 3+ years of 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 regarding 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.

Candidates must have valid working VISA in Ireland or European Passport.

Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-group.com.

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to akremenskas@berkley-group.com

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