Advanced Bioprocessing Scientist
MeiraGTx · Shannon, Munster, IE
Your mission The main purpose of the Advanced Bioprocessing Scientist is to perform advanced manufacturing and continuous improvement activities for the prod...
Job description
Your mission The main purpose of the Advanced Bioprocessing Scientist is to perform advanced manufacturing and continuous improvement activities for the production of sterile gene therapy products in line with current Good Manufacturing Practice (cGMP). Job Description: Major Activities: - Responsible for driving own development and coaching/training of Bioprocessing Scientists in line with the Training Plan. - Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures. - Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken. - Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state comply with MeiraGTx procedures including Health and safety and GMP. - Responsible for performing manufacturing activities in multiple unit operations, following all GMP instructions and good practices to manufacture the required products. - Responsible for identifying, reporting and investi...