Assistant Manager

Designation Assistant Manager Job Location Bangalore Job Grade 8-II The Company Syngene International Ltd BSE 539268 NSE SYNGENE ISIN INE398R01022 is an integrated research development and manufacturing solutions company serving the global pharmaceutical biotechnology nutrition animal health consumer goods and specialty chemical sectors Syngene s 4500 scientists offer both the skills and capacity to deliver great science robust data management and IP security and quality manufacturing at speed to improve time-to-market and lower the cost of innovation With a combination of 1 9 Mn sq ft of specialist discovery development and manufacturing facilities as well as dedicated research facilities for Amgen Baxter Bristol-Myers Squibb and Herbalife Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA Key Result Areas Role-specific Maintain good aseptic behavior inside BMP4 facility Perform all the Downstream activities like Assembly preparation accessories arrangement for step Dispensing of raw materials and consumables Reconciliation of excess and unused raw materials and consumables Buffer Preparation Harvest Clarification Chromatography operation Low pH and Intermediate depth filtration Viral filtration TFF Operation and 0 2 filtration Operating and cleaning of downstream equipment s as per standard operating procedures and EOP Monitoring and process control of the specific Operations of the Downstream Maintenance of Quality records Perform In-process product sampling sample submission and storage Perform room owner responsibility for the assigned DSP area Perform equipment instrument ownership related responsibilities related to DSP Initiate Complaint Slips work orders for DSP related areas and equipment Coordinate with QA for line clearance Maintaining process area All-time ready for Inspection audit purpose Maintain facility and assigned zone all-time ready for visit and audit Involve and support in execution of batches as and when required and perform error free operation as per Batch Manufacturing Record BMR Involve in shipment of samples final product as per packing and dispatch record Work proactively to meet all document s on time closure requirement Execute the protocols related to Downstream related activity and equipment instrument qualification Involve in Shipment of samples final product as per packing and dispatch record Execute the batch activity as per BMR and report nonconformity to the supervisor Issuance of annexures RM consumables and BMRs Track the work order status and ensuring timely closure Education and Experience Education Master s degree in Pharmaceutical Sciences Chemical Engineering Biotechnology or related field Industry Experience Minimum 9-12 years of relevant practical experience in Downstream Manufacturing for biopharmaceuticals specifically with CHO cell lines for monoclonal antibodies fusion proteins etc Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity EEO to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local law In addition Syngene will provide reasonable accommodations for qualified individuals with disabilities Pls visit us at to know more about us and what we do