PE Global is currently recruiting for a Tech Transfer Lead on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.
The successful candidate will need to be prepared to participate in 24/7 support once or twice a quarter (depending on business needs) for approximately 1-2 weeks at a time.
Confirmed shift pattern: It’s 2 days on 7am-7pm, 2 nights on 7pm-7am, 4 days off.
Overview
This role requires the candidate to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes.
In addition, the candidate will be expected to provide technical support to biologics drug product manufacturing as part of the global Process Development organization, with the intention of moving to a new building that will house single-use end-to-end processes and new syringe fillers.
Responsibilities
Supports new product introductions to PM2 and PM3 from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer to PM2 or PM3.
Be accountable for the 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 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 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.
Develop characterisation studies, engineering runs, electronic batch record creation, validation plans, process performance qualifications for syringe filling.
Ensure all aspects of activity within any given process validation adhere 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 deliver against organizational goals and project milestones.
Pre‑approve and post‑approve process validation protocols and assessments from a quality system documentation perspective.
Communicate actively across functions and sites and act as a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions.
Act as the responsible point of contact from the site for the transfer project for drug product teams and Global Operations Teams.
Assist in developing any existing validation program to ensure continued compliance with 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.
Education and Experience
Third level Bachelor’s degree in science, engineering or a relevant quality discipline with 5 years of experience in a similar role OR Master’s degree and 3 years of directly related experience.
Knowledge of cGMPs and other worldwide regulatory requirements.
Problem‑solving ability and excellent oral and written communication skills.
Experience supporting commercial protein drug product 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 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.
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