Job Description In depth understanding of processes vial – Drug substance on mammalian/microbial based technologies. Monitor the manufacturing process, data acquisition, trending and analysis of manufacturing data. Identify areas for improvements (process efficiencies, cycle time, analytical methods variability & their impact on process etc.). In depth understanding of the various aspects and approaches of technology transfer, scale up principles. Work with R & D / Pilot plant team in execution of experimental runs and scale down experiments to support manufacturing process changes. Gain understanding of processes involved before tech transfer. Review of TTDs, MFRs, BPRs and any other relevant document to provide scientific inputs. Responsible for preparation of PPQ protocols and reports. Preparation of study protocols and reports, summary reports, technical reports to support manufacturing process. Carryout the investigations of process deviations and provide shop floor support during investigations. Review of process related change controls, deviations and CAPA, co-ordinate the approval process and follow up to close out. 

 

Work Experience

2 to 5 years of experiance 

Education MastersB.Tech in BiotechnologyCompetencies 1. Strategic Agility2. Innovation & Creativity3. Customer Centricity4. Developing Talent5. Result Orientation6. Process Excellence7. Collaboration8. Stakeholder Management