Needs for Upstream Cell culture manufacturing specialist

Job Description

Job Title: Junior Manager/Assistant Manager Upstream Cell culture manufacturing Job Location: Bengaluru, India Reporting to: Function head Job Grade: 8 About Syngene Syngene International Ltd is an integrated research, development, and manufacturing organization providing scientific services - from early discovery to commercial supply. We offer services in a wide range of industrial sectors, including pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical companies. Our culture of scientific innovation is driven by the expertise of our highly qualified team of 5,000 employees and is supported by state-of-the-art infrastructure and market-leading technology. 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. Core Purpose of 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. Role Accountabilities:
• Supervise 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 always in the workplace ensuring individual and lab/plant safety.
• Attend training on Environment, Health, Safety, and Sustainability (EHSS)
Education
• M.Sc/M.Tech/B.Tech in Biotechnology
Relevant experience
• 6-12 years of relevant work experience in Biotech company
Professional Skills and Capabilities
• 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.,

Keyskills :
continuous improvement facilitationmedia preparationcell cultureequal employment opportunitybatch records