Assistant Manager-Upstream Manufacturing

Job Description

Designation: AssociateManager, Biopharmaceutical Operations Job Location: Bengaluru, India Reporting to: Deputy Manager, Biopharmaceutical Operations Job Grade: 7 Operating Unit : Biopharmaceutical Department: Biopharmaceutical Operations The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene s 4500+ scientists offer both skills and the 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 dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA. The Role The role is responsible to execute all the Upstream related activities including assembly preparation, feed and media preparation, gas bank management, USP cleanroom upkeep, Bioreactor readiness and operation. Key Result Areas Role-specific:
• Performing all upstream activities starting from assemblies preparation, Media preparation, Vial thaw, Feed preparation and filtration, Bioreactor operations to Batch harvest. Monitoring and process control of specific operations of Upstream.
• Involving in each and every phase of commissioning and Qualification activity of BMP1
• Maintenance and Calibration of Operations equipment in coordination with Maintenance Department.
• Monitoring of process efficiencies.
• Reporting of non-conformities and implementation of corrective/preventive actions in specific areas of operation.
• Preparation and review of Operations related procedures.
• Preparation, revision and review of Batch Manufacturing Records.
• Preparation of general validation protocols and report, Performance qualification documents.
• Review of Quality department Protocols related to Operations.
• Reporting Deviations and Change controls from Operations to QA.Verify PM, check the log books and ensure the clean room requirements in order to get line clearance from QA for batch execution. Possess the knowledge and exposure to Environment, Health, Safety, and Sustainability (EHSS) practices.
• Follow Environment, Health, Safety, and Sustainability (EHSS) requirements at all times in the workplace ensuring individual and lab/plant safety.
• Attend training on Environment, Health, Safety, and Sustainability (EHSS)
Education and Experience Education Master s degree in Chemistry Industry Experience 9-12 years Required Skill sets
• Capable of shift supervision for USP operations
• Manage shift schedule for USP operations
• Support in hiring process for USP
• Understanding of Commissioning and Qualification procedures and guideline requirements for the same
• Understanding of QMS requirements
• Capable of preparation, revision and review of master Batch Manufacturing Records (BMRs
• Capable of reviewing the executed batch records (BMRs)
• Capable of identifying gaps in existing system or procedure and provide solution for the same
• Capable of handling client and regulatory audits
• Decent following-up tendency to get the work completed within timelines
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.Please visit us at https://syngeneintl.com/ to know more about us and what we do. ,

Keyskills :
batch recordsaccountssalesconsumer goodsmistat