Sr. Executive-Downstream Manufacturing

Job Description

Designation: Senior Executive, Biopharmaceutical OperationsJob Location: Bengaluru, IndiaReporting to: Assistant Manager, Biopharmaceutical OperationsJob Grade: 9Operating Unit : BiopharmaceuticalDepartment: Biopharmaceutical OperationsThe CompanySyngene 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 RoleExecution of BMP4 Downstream manufacturing operations by adhering to Syngene safety and GMP practices.Key Result AreasRole-specific: Common Responsibilities:
• Adherence to all procedures related to data integrity
• Ensure there are no violation of any environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
• Wear all required PPE at all times
• Understand and demonstrate that you are responsible for the safety of yourself & colleagues by following all necessary safety protocols at all times
• Identify near-misses and potential incidents proactively and communicate those.
• Attend all assigned mandatory training related to data integrity, health, and safety measures
Specific Responsibilities:
• Responsible for co-ordinate C&Q activities through a technical collaboration with various internal and external cross-functional teams and SME s.
• Responsible for execution of BMP4 downstream manufacturing operations by adhering to Syngene safety and GMP practices .
• Preparation and review of qualification documents URS, SLIA, Validation Plan, System Boundary, CLIA, DQ, RA, RTM, IQ, OQ, and PQ and applicable deliverables based on qualification procedure.
• Coordination with the cross-functional team for qualification document review and approval.
• Execution of installation and operational qualification for downstream equipment.
• Preparation and revision of SOPs related to facility and process equipment.
• Preparation and revision of BMR and checklists and associated written documents in operations.
• Compliance with current Good manufacturing practices and keep facility ready all the time as per regulatory requirements.
• Maintenance of quality records.
• Adherence to Standard Operating Procedures, Operational control procedures
• Verification of operations equipment calibration.
• Adherence to pollution control and safety requirements.
• Meet training requirements
• Ensuring readiness of prerequisites for batch activities
• Support and technical collaboration with Process development, MSAT, and Operational Excellence to handle scale-up and at-scale technology transfer aspects.
Education and ExperienceEducationM.Sc/B.Tech in BiotechnologyExperience3-6 yearsFunctional or Technical skills Required
• Handling of Downstream equipment.
• Knowledge of GMP activities
• Willing to work in shifts
Equal Opportunity EmployerIt 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 :
equal employment opportunityanimal healthcontinuous improvement facilitationstandard operating procedures