Job Title: Tech Transfer Lead
Description:
This role requires a Tech Transfer Lead to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes. The candidate will establish themselves in a product lead role where the majority of input provided will be leading of process performance qualification (PPQ).
Responsibilities:
* Leads 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 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.
* 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 at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones.
* Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
* Act as the responsible point contact from site for the transfer project for drug product teams and Global Operations Teams.
* Assist in the development of any existing validation program to ensure continued compliance to 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.
Requirements:
* Third level Bachelors degree in science, engineering or a relevant quality discipline with 5 years experience in a similar role OR Masters degree & 3 years of directly related experience
* Knowledge of cGMPs and other worldwide regulatory requirements.
* Problem solving ability and excellent oral and written communications skills.
* 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.
What We Offer:
We are committed to providing a supportive and inclusive work environment that encourages our employees to grow and develop their careers. We offer competitive salaries, comprehensive benefits packages, and opportunities for professional growth and development.