Tech Transfer Leads (Intermediate)

Team Horizon is seeking a Tech Transfer Leads (Intermediate) for our client based in Dublin. This role will require 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 construction that will house single use end to end processes and new syringe fillers.

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:

• Development of documentation and process design for characterisation studies, engineering runs, electronic batch record creation, validation plans, process performance qualifications for 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.


• 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.


• 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.

What you need to apply:

• Third level Bachelor’s degree in science, engineering or equivalent discipline with 4 years experience in a commercial manufacturing or NPI role OR Master’s degree & 2 years of directly related experience OR Associate’s degree & 7 years of directly related experience.


• Strong technical writing skills.


• 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).


• 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.