LSC require a Technical Transfer Lead (Senior) for our biotech client based in Dun Laoghaire, Dublin. As part of the Process Development – NPI group this dedicated technical expert will be be accountable for success of the transfer project from project initiation to the transfer, through regulatory approval and will execute processes on site, per the required technology, characterization, and drug product specific knowledge that will be transferred to the facility. This position provides leadership and expertise for operational, scientific and engineering technology, including interface with quality and regulatory policies.
Your primary responsiblities will include:
o Development of validation plans, process performance qualifications for vial and syringe filling.
o Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
o 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.
o Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones.
o Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
o Actively communicates across functions and sites and is a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions.
You will have :
o 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.
o Knowledge of cGMPs and other worldwide regulatory requirements.
o Problem solving ability and excellent oral and written communications skills.
o Doctorate or Masters in Science or Engineering.
o 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.
o 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.
o Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
o Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
Please contact Kathy for full details on this role or apply directly through this advert.