Needs for Junior Manager, Biopharmaceutical Operations

Job Description

Designation: Junior Manager, Biopharmaceutical OperationsJob Location: Bengaluru, IndiaReporting to: Assistant Manager, Biopharmaceutical OperationsJob Grade: 8Operating 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 Role The role is responsible to ensure Downstream manufacturing process at Syngene s new microbial manufacturing facility for recombinant microbial products and biotheraputics at 200L and 500L scaleKey Result AreasRole-specific:
• Downstream process execution: Batch process operation/unit operation including CIP/SIP, preparation of downstream accessories. Close monitoring of batch performance data.
• Preparation of qualification documents as applicable as per SOP and coordinate with cross functional team for timely review and approval.
• Execution of Installation, Operational and performance qualification for downstream equipments.
• Preparation of SOPs related to facility and process equipments
• Adherence to Standard Operating Procedures, Operational control procedures.
• Maintenance of Operations equipment in coordination with maintenance Department.
• Reporting Deviations and Change controls from Operations to QA and implement the corrective actions.
• Upkeep the required stock of consumables for batch activity and take follow-up with respective team for its procurement and timely availability.
• Issue, Checking and Review of operations documents.
• Preparation and revision of Batch Manufacturing Records.
• Preparation of buffer/solvents as per process requirement
• Investigation of Batch failures in Operations if any
• Review of written Batch records, checklists and associated written documents in Operations.
• Compliance to current Good manufacturing practices and keep facility ready all the time as per regulatory requirements.
• Adherence to pollution control and safety requirements.
• 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 EducationMaster s degree in BiotechnologyIndustry Experience 3-6 years of relevant experienceOther competencies required for the role
• Expertise in downstream unit operations.
• Strong Hands on experience with Chromatography, Centrifugation, Cell lysis and filtration.
• Exposure to handle of recombinant proteins and biotherapeutics projects in cGMP area.
• Sound knowledge and awareness of GMP controls, Quality systems and regulatory aspects.
• Experience on the Equipment Qualification and commissioning aspect.
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.,

Keyskills :
troubleshootingsafetymechanicalstandard operating proceduresconsumer goodssap