Upstream Manufacturing

As an Upstream Manufacturing at Syngene, you will play a crucial role in the manufacturing process by following good aseptic behavior inside Biologics operations facility and performing various upstream activities such as Assembly preparation, Media Preparation, Vial thaw, Feed preparation and filtration, Bioreactor Operations to Batch Harvest. Your responsibilities will also include monitoring and process control of specific operations, maintenance of quality records, in-process product sampling and storage, preparation and review of operation related documents, as well as ensuring traceability from raw material till finished product. Additionally, you will be responsible for performing room owner and equipment/instrument ownership related responsibilities, initiating Complaint Slips for USP related areas and equipment, coordinating with QA for line clearance, and maintaining process area inspection-ready at all times. Key Responsibilities: - Follow good aseptic behavior inside Biologics operations facility - Perform various upstream activities such as Assembly preparation, Media Preparation, Vial thaw, Feed preparation and filtration, Bioreactor Operations to Batch Harvest - Monitor and control specific upstream operations - Maintain quality records and ensure traceability from raw material till finished product - Perform in-process product sampling and storage - Prepare and review operation related documents - Perform room owner and equipment/instrument ownership related responsibilities - Coordinate with QA for line clearance - Maintain process area inspection-ready at all times - Execute protocols related to upstream activities and equipment/instrument qualification Qualifications Required: - Masters degree/ bachelors degree in pharmacy, Masters degree in Pharmaceutical Sciences - Minimum 2 -10 years of relevant practical experience in mAbs downstream process At Syngene, safety is a top priority and as an Upstream Manufacturing, you will be expected to adhere to established Environment, Occupational Health, Safety and Sustainability (EHSS) practices for a safe work environment. You will also need to complete assigned trainings in a timely manner, comply with training procedures and calendars, and adhere to Current Good Manufacturing Practices and Good Documentation Practices. Additionally, you will be responsible for reporting nonconformities and deviations to supervisors, participating in on-time initiation and closure of deviations, investigations, CAPA and change controls, and following organizational policies & procedures on EHSS, POSH, Data Integrity and IT security. Syngene is an Equal Opportunity Employer committed to providing a safe and inclusive work environment. To learn more about us and what we do, please visit our website at https://syngeneintl.com/.,