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Details

Senior Tech Transfer Lead


Reference:KG-AQDO-642044 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Our client is one of the world's largest biotechnology companies, with approximately 20,000 employees. This is an excellent opportunity to join a leader in their field, and develop your career.

This role will require the candidate to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes at ADL.
The candidate will establish themselves in a product lead role where the majority of input provided will be leading of process performance qualification (PPQ).
In addition, the candidate will be expected to provide technical support to biologics drug product manufacturing at ADL as part of the global Process Development organization.

Responsibilities:
Leads new product introductions to ADL 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 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 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.
The position will report to Process Development Principle Engineer. Moderate international travel might be required during the course of the project.

Basic Qualifications
•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.
•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 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.

If you would like further Information you can contact the recruiter directly:

Kevin Silke | Tel: +353 (0) 1 507 9255