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Posted 10 hours agoTech Transfer Lead (Junior)
Dún Laoghaire, IrelandOn-site
Responsibilities
- Support commercial drug product manufacturing operations with technical evaluation of Change Control/NC/CAPA and technology transfer.
- Ensure that the site meets the quality
- Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
- Collate and report on relevant shipping and filter validation.
Requirements
- requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related to technology transfer.
- Contribute to product quality assessments and process flow documents. Basic
- Qualifications Third level Bachelor's degree in science, engineering or equivalent discipline with 2 years
- experience in a commercial manufacturing or NPI role OR Master's degree & 1 years of directly related
- experience OR Associate's degree & 5 years of directly related experience.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- 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).
- 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.
- 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.
Additional details
- This role will require the candidate to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes on site.
- With the intention of moving to a new building construction that will house single use end to end processes and new syringe fillers.
- Responsibilities would include the following: Support and/lead new product introductions to the site PM3 from concept to PPQ from a Process Development perspective and complete product filings.
- 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 freeze/thawing, formulation, filling syringes, 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 process validation, input on design for new parts of the facility where needed.
- The position will report to Process Development Manager.
- Moderate international travel might be required during the course of the project(s). Key
- Responsibilities Development of documentation and process design for characterisation studies, engineering runs, electronic batch record creation, validation plans, process performance
- Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.