Scientific Officer / Senior Scientific Officer

Job Description

Position Title : Senior Scientific Officer/Scientific Officer Grade : E - 7 Reporting To : Section Manager Natureof Position : Permanent EducationalQualification : M.Sc. / M.Tech (Biotechnology/Microbiology) Experience : 4 to 7years Locationofwork : Lalru Roles and Responsibility: 1. Knowledge about the updated cGMP guidelines 2. Knowledge about Cleaning, Operation, documentation and maintenance of chromatography systems (AKTA series) and water bath. 3. Responsible for online documentation as per cGMP along with routine log book management of production activity and equipment. 4. Knowledge of qualification (IQ/OQ/PQ) of chromatography systems (AKTA series), TFF systems, and refrigerators, cold rooms, HVAC/UDAF and tanks. 5. To ensure the entire downstream processing activity to be carried out as per compliance and process requirement 6. Knowledge for preparation and implementation of SOP/BMR/Protocols 7. Knowledge of adsorption, desorption, depth filtration, coarse and micro filtrations, centrifugation, ultrafiltration systems, Ion exchange, size exclusion and affinity chromatography. 8. Responsible for the execution of the purification modification with project team as and when required. 9. Knowledge of column packing 10. To ensure the effective cleaning and sanitation of the Core area, and systems as per schedule. 11. To ensure GMP compliance as per the applicable National and International rules and guidelines Such as Schedule M and World Health Organization (WHO). 12. Well versed with UNICORN software and integrity tester 13. Well versed with handling of QMS elements 14. Media fill, sterile filtrations, online particle counter and chartless temperature recorder 15. Hand on in MS word and excel 16. Calibration and verification of weighing balances, pH meters and spectrophotometer. 17. Knowledge of vNPC monitoring Competencies Required: 1. Thorough knowledge and understanding of column chromatography, column packing and TFF systems . 2. Understand Aseptic Behavior aseptic handling, aseptic working & aseptic cleaning. 3. Must understand Sterile Operations, Scientific practices & process criticalities of Vaccine manufacturing. 4. Analytical approach – Good in trend analysis, data evaluation & process calculations. 5. Adequate, Timely & Quality deliverance/ Output within stipulated timeframe. 6. Effective Communicator 7. Understanding of different room grades and area monitoring. 8. Motivate Team and Enable High Performance 9. Effectively Manage Absenteeism / Vacancy 10. Effective Performance Reviews of the Team and their Training responsibilities Preferred candidate profile