Senior Executive - Gene Therapy, GMP Upstream

Job Description

GMP Upstream role KEY RESPONSIBILITIES Carries out the Cell and Gene Therapy manufacturing in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs) Executes manufacturing operations in clean room, following cGMP requirements and wearing sterile gowning Prepares equipment and raw materials for manufacturing Performs (preparation and execution) aseptic process simulation (media fill) Executes all steps outlined in the batch records Reads and fulfils in real time production batch records and equipment logbooks Perform and assures the cleaning state and routinary maintenance of the manufacturing equipment Immediately reports any deviations occurred during manufacturing execution or preparation, errors in the documentation or any potential matter relevant for the correct completion of the manufacturing to the management Carries out the work in compliance with company Safety Policies Prepares for production (engineering batch, full scale batch, clinical batch) and identification of batch specific requirements Reports any accidents, incidents and injuries immediately notifying any hazards, unsafe procedures, or conditions in the workplace Keep up to date by participating in training courses and opportunities Participates at writing and revision of SOPs and Manufacturing documents Participate to the quality investigation from production side Participates at Regulatory Authorities audits for aspects pertaining the role Supports the activities for periodic qualification of clean room interacting with QA and engineering Is involved in process-related meetings Collaborates with Process Development team to bring manufacturing process in GMP Experience and Knowledge Experience in clean room environments Previous experience in fermentation and cell culture is mandatory Experience in manufacturing of any or all - plasmids, viral vectors, or Biologics GMP upstream is essential Experience of any or all tasks including performing aseptic fermentation and cell culture techniques, operation of large-scale bioreactors (50 to 500L) and related equipment. Good communication skills with the ability to liaise with internal and external stakeholders Showing initiative in executing plans and delivering objectives. Problem solving mindset. Strong team player Qualifications BSc or MSc Degree or equivalent in Life Sciences or Biological / Chemical Engineering with 3-5 years of experience in cGMP setting.