Downstream Manufacturing

Designation Downstream Manufacturing Job Location Bangalore About Syngene Syngene is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply At Syngene safety is at the heart of everything we do personally and professionally Syngene has placed safety at par with business performance with shared responsibility and accountability including following safety guidelines procedures and SOPs in letter and spirit Key Result Areas Role-specific Maintain good aseptic behaviour inside Biologics operations 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 Preparation and review of operation related documents 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 Preparation of general Downstream related procedures protocols risk assessment and BMRs 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 Preparation and periodic revision of equipment cleaning checklist ECC as ad when required Execute the batch activity as per BMR and report nonconformity to the supervisor Review of executed Documents on time Issuance of annexures RM consumables and BMRs Track the work order status and ensuring timely closure Involve in upstream related activities under supervision of upstream supervisor Education and Experience Education Master s degree bachelor s degree in pharmacy Master s degree in Pharmaceutical Sciences Industry Experience Minimum 2 - 10 years of relevant practical experience in mAbs downstream process Other competencies required for the role Follow the established Environment Occupational Health Safety and Sustainability EHSS practices for safe work environment and adhere to the highest standards of quality integrity compliance for every work activity Complete the assigned trainings in a timely manner and comply with the training procedure training calendar Attend all assigned mandatory trainings related to data integrity health and safety measures Compliance to Current Good Manufacturing Practices and Good Documentation Practices Adherence to Standard Operating procedures Operational control Procedures Participate in support the trainings on procedures protocols and On-the-Job activities Follow the discipline of reporting structure at times of escalation Report nonconformities deviations to the respective supervisor s and or line manager s Participate in support for on-time initiation closure of deviations investigations CAPA and change controls Safety and DI Responsibilities Adhere to organizational policies procedures on EHSS POSH Data Integrity and IT security Always wear the applicable PPEs and adhere to any other Environment Health and Safety EHS requirements in the workplace for individuals lab plant safety Understand all necessary safety protocols and always follow the same to ensure safety for all Proactively identify near-misses potential incidents and communicate to supervisor and or line manager or through the respective web portals 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