Process Development Scientist Opportunity
About the Role:
We are seeking a highly skilled Process Development Scientist to join our team. As a key member of our process development organization, you will be responsible for providing process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes.
In this role, you will provide technical support to biologics drug product manufacturing as part of the global Process Development organization. You will be accountable for the success of product transfer projects from initiation to transfer, through line characterization, engineering studies, process performance qualification, and ultimately to regulatory approval.
You will also provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation for parenteral products through the NPI or post-NPI phases. Additionally, you will provide process development knowledge for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer, and validation.
Responsibilities:
* Support new product introductions from a Process Development perspective and serve as the Process Development SME for these products following completion of the transfer.
* Be accountable for the success of product transfer projects from initiation to transfer, through line characterization, engineering studies, process performance qualification, and ultimately to regulatory approval.
* Provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation for parenteral products through the NPI or post-NPI phases.
* Provide process development knowledge 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.
Requirements:
* Bachelor's degree in science, engineering, or a relevant quality discipline with 5 years of experience in a similar role.
* Knowledge of cGMPs and other worldwide regulatory requirements.
* Problem-solving ability and excellent oral and written communication skills.
* PREFERRED QUALIFICATIONS: Doctorate or Master's in Science or Engineering; experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as sterile processing, process characterization, tech transfer, or validation.
What We Offer:
* Contract role - Hourly rate €45 - €60 per hour.
* Minimum 12-month contract with the possibility of an extension.
* Moderate international travel might be required during the course of the project.
* 24/7 support participation may be required.
Benefits:
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant. Our client is a leading international Biotechnology company with a state-of-the-art aseptic manufacturing facility in Dun Laoghaire, South Dublin. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
The position will report to a Process Development Senior Engineer. Excellent communication skills are essential for this role.
Candidate must have strong knowledge of Quality systems, Drug Product Manufacturing, and Validation.
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