Your mission
Purpose of Job
The main purpose of the Bioprocessing Scientist is to support GMP-compliant activities for the production of sterile gene therapy products.
Job Description
Major Activities
* Perform production processes following SOPs and GMP practices to manufacture required products.
* Proficient in aseptic manufacturing techniques to ensure the manufacture of sterile products.
* Operate within GMP guidelines in a clean room environment to ensure compliance.
* Monitor the GMP facility daily to ensure safe and compliant operations for gene therapy product manufacturing.
* Perform routine cleaning of the manufacturing facility.
* Review and update process documents as needed.
* Conduct environmental monitoring of the manufacturing facility.
* Maintain the manufacturing facility and storage areas in a fit-for-purpose state.
* Conduct stock checks and assist with inventory management.
* Assist in stock control, including ordering, receipt, storage, and release of materials.
* Comply with MeiraGTx procedures, including health and safety and GMP standards.
* Ensure equipment calibration and maintenance in line with SOPs.
* Report procedural problems and deviations.
* Participate in planning to ensure timely delivery of products.
* Perform other duties/projects within your skills and responsibilities.
* Support technology transfer activities if required.
Job Responsibilities
* Ensure compliance with GMP, Data Integrity, and GDP.
* Complete training in a timely manner before undertaking tasks.
* Manage GMP documentation such as issues, CAPAs, change controls, BMRs, and audit actions, ensuring timely closure and compliance.
Job Background
* Degree or certificate in Bioprocessing or relevant scientific discipline with practical lab experience, or equivalent experience.
* Experience in pharmaceutical manufacturing, preferably biologics and aseptic techniques.
* Good understanding of GMP.
* Experience with sample preparation and analysis.
* Numerate with proficiency in Microsoft Office (Word, Excel, PowerPoint).
Why us?
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