Senior Research Associate/Associate Scientist/Senior Research Associate- Upstream MSAT

The Role:

• To perform activities related to MSAT function for technology transfer for upstream (microbial), scale up, deviation investigation, process trouble shooting, technical report writing as per guidance and other documents available in Syngene.
• Provide technical instructions and upstream experiments as per the requirement, data analysis and interpretation of data along with feedback to manufacturing team/Process Development team.

Role-specific:

• Perform internal and external upstream technology transfer initiatives.
• Preparation, review of TTD and BMR review.
• Participate in planned and unplanned deviation investigation and perform/support related experimentation.
• Understand the facility constraint and perform gap assessment, shop floor support for technology transfer and scale up related activities. 
• Author technical reports. Documentation includes gap analysis, risk assessment, statistical data analysis and other related technical reports.
• Data collection/capturing, monitoring, trending and analyzing the data from cGMP campaign and authoring of summary reports.
• Trouble shooting of process/product related concerns.
• Represent USP technical team for client interactions and telecoms. Coordination with cross functional teams.
• Ability to work in a team and willingness to work in shifts including night shiftsPossess 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)

Functional or Technical skills Required

• Hands on experience on upstream microbial/mammalian process.
• Experience in process scale up/scale down, risk assessment and statistical data analysis using tools like JMP, Stat-Ease etc.
• Knowledge on facility fitment, process mapping will be added advantage.
• knowledge of upstream unit operations for large molecule is the must. Preferred candidate should have worked on microbial and/or mammalian culture derived products.
• Should be conversant with interpretation of analytical and process data.
• Should be conversant with scale-up principles and have been involved in at least one scale-up related activity.
• Proficient in handling of Single use and SS bioreactors, incubators etc and interpreting experimental results using standard tools.
• Possess excellent communication and good writing skill and should be proficient in MS excel/word.