Technicial Transfer Lead– Team Horizon
We are seeking applications for an experienced Technical Transfer Lead to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes at our client site.
You will be the product lead where the majority of input provided will be leading of process performance qualification (PPQ). You will also provide technical support to biologics drug product manufacturing.
 
This role a WFH role until covid restrictions are lifted. You will then be required to work full-time onsite thereafter - with some flex to WFH home, no more than 2 days/week.
 
Some shift work may be required as part of the role.
 
Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

 
What you will be doing:

• You will lead new product introductions to our client site from a Process Development perspective and then serve as the Process Development SME for these products following completion of the transfer.
• 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.
• Key responsibilities include:
• Development of validation plans, process performance qualifications for vial and syringe filling.
• 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.
• 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.
• Act as the responsible point contact from site for the transfer project for drug product teams and Global Operations Teams.

• A relevant third level Bachelor’s degree in science, engineering or a relevant quality discipline couple with relevant experience in a similar role.
• Knowledge of cGMPs and other worldwide regulatory requirements.
• Preferred Qualifications
• 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.