Senior Research Associate/Associate Scientist/Senior Research Associate - Downstream MSAT

The Role:

• The role is responsible to perform the activities related to MSAT function for downstream process technology transfer, scale up, deviation investigation, process trouble shooting, technical report writing and review batch records.

Role-specific:

• Execution of internal and external technology transfer initiatives.
• Understand the facility constraint, perform facility fitment analysis and mapping.
• Provide shop floor support for technology transfer and scale up related activities. 
• Preparation of TTD and BMR review.
• Author technical reports. Documentation includes gap analysis, risk assessment, statistical data analysis and other related technical reports.
• Participate in planned and unplanned deviation investigation and perform/support related experimentation.
• Trouble shooting of process/product related concerns.
• Data collection/capturing, monitoring, trending and analyzing the data from cGMP campaign and authoring of summary reports.
• Shop floor support for process validation and process characterization.
• Coordination with cross functional teams
• Execution of laboratory experiments and documenting them in details in laboratory note book as per the requirement.
• 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)

Functional or Technical skills required:

• Hands on experience on downstream techniques like chromatography, depth/micro filtration centrifugation, viral filtration, refolding, and precipitation etc and process analytics.
• Experience in process scale up/scale down, risk assessment and statistical data analysis.
• Knowledge on facility fitment, process mapping will be added advantage.
• knowledge of downstream unit operations for large molecule is must. Preferred candidate should have worked on Mammalian cell culture derived mAb and/or non-mAb protein downstream purification.
• 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.
• Experience with single use systems will be added advantage.
• Possess good writing skill and should be proficient in MS excel/word.