About Your New Employer
* Join a leading biotechnology and pharmaceutical company with a strong commitment to quality and innovation.
* Work at our state-of-the-art facility in Sligo, Ireland, where cutting-edge technology and processes are at the forefront of our operations.
* Be part of a dynamic and collaborative team that values excellence, continuous improvement, and professional growth.
About Your New Job
As the Process Scientist, you will be an integral part of our Quality team, focusing on Technical Transfer (TT) activities to ensure successful transfer of processes and technology. Your responsibilities will include:
* Planning and coordinating TT activities to support new product introductions and product support.
* Developing instructions for production operations such as tableting and packaging.
* Reviewing and reporting on TT activity data and working with the scheduling team to ensure timely execution.
* Supporting the Manufacturing team throughout the manufacturing process and developing necessary protocols.
* Using a risk-based approach for planning, readiness, and execution of TT activities.
* Developing functional partnerships with site business units to address TT-related issues.
* Providing on-the-floor process support and introducing statistically based tracking metrics.
* Monitoring process CPPs and updating process databases.
* Investigating and closing out non-conformances, deviations, and change control requests.
* Performing sample analysis and coordinating external test laboratories when required.
* Presenting issues and developing business cases for courses of action as appropriate.
* Engaging with and supporting Quality and Regulatory Audits.
What Skills You Need
* A minimum of a Master's degree in a technical discipline (e.g., biochemistry, chemistry, biotechnology, biopharmaceuticals). A PhD is desirable.
* At least
5 years of experience
in the
biotechnology and/or pharmaceutical
industry, with operational experience in new product introductions and product support.
* Knowledge of
pharmaceutical manufacturing processes
and equipment (oral solid dose, parenterals, and/or biologicals).
* Experience in authoring, reviewing, and executing process validation studies and reports.
* Experience with vaccines
is preferable, particularly in product development and stewardship.
* Proficiency in written and spoken English.
* Excellent understanding of GMP, ICH, and compendia regulations and guidance.
* Strong problem-solving, risk management, and decision-making skills.
* Excellent collaboration and communication skills.
* Attention to detail and significant data review experience.
* Effective time management and multi-tasking skills.
What's on Offer
* Competitive salary and benefits package.
* Opportunities for professional development and career growth.
* A dynamic and collaborative work environment.
* Exposure to cutting-edge technology and processes in the biotechnology and pharmaceutical industry.
What's Next
Apply now by clicking the "Apply Now" button or call me, Ross Keyes, on If the job isn't quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available.