Technical Transfer - (Intermediate) Specialist
A market-leading bio-pharmaceutical company based in south Dublin, Ireland, is looking for a Technical Transfer - (Intermediate) Specialist.
This role will require the candidate to provide process development support primarily to new product introductions (NPI) and life-cycle 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: 2 days on 7am-7pm, 2 nights on 7pm-7am, 4 days off.
The Job:
* Provide solutions when troubleshooting 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:
* 5+ 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.
Seniority Level
Entry level
Employment Type
Contract
Job Function
Product Management
Industries
Pharmaceutical Manufacturing
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