Senior Process Specialist

Team Horizon is seeking a Senior Process Specialist for our client’s site in Dublin. This person will be the site lead for the successful development, planning, execution, and support of project plans related to technology transfer and marketed product enhancement activities.

The Senior Process Specialist liaises with both the site-based teams (QA / QC / Operations / Engineering) the Global QA and Science and Technology functions for the planning and execution of these activities, as well performing trouble shooting of existing and new processes and carrying out technical process investigations. This position reports to the Director of Pharmaceutical Technology.

Why you should apply:

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  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.


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  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.


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  Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

 



What you will be doing:

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  Responsible for the successful development, planning, execution, and support of project plans related to technology transfer and marketed product enhancement activities, ensuring site readiness at each project milestone.


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  Lead on-site new product development projects and ensure the successful execution of the Technical Operation site project programs.


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  Lead the preparation and execution of feasibility, NDA, demonstration (pre-validation) and Validation campaigns.


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  Lead the ongoing technical analysis and support of newly transferred and existing products, including process optimization, lifecycle management, batch scaling and timely troubleshooting, performing root cause analyses and recommendation of preventative and corrective actions.


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  Serve as the subject matter expert (SME) on the site’s products, representing the site to internal and external stakeholders (for example FDA).


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  The Senior Pharmaceutical Technology Scientist is responsible for the safe, compliant, and efficient execution of job duties in a team environment.


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  And any other duties as assigned

 



What you need to apply:

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  A third level qualification in Chemistry or related Science, preferably a bachelor’s degree.


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  5 years related experience and/or training; or equivalent combination of education and experience.


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  Experience in pharmaceutical manufacturing facility.


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  Experience working with pharmaceutical processing technologies and good understanding of 21CFR / cGMP documentation and electronic systems requirements.


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  Demonstrated experience applying sound and critical reasoning to troubleshoot complex process challenges.


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  Demonstrated success in making effective and persuasive presentations on complex topics to upper management.


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  Experienced in aligning individuals and teams to business objectives.


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  Exposure to Lean manufacturing concepts a plus.


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  Experience in managing by metrics.