Puja Sharma

Responsible, driven, skilled individual with over six years of experience in downstream RND. Committed to the motto of organization and put forward a conscious effort to overcome challenges. Expertise and enthusiasm for the study of downstream processing and protein purification. I'm eager to demonstrate my abilities as an RND scientist by joining an organization.

• Practical proficiency in purification of monoclonal antibodies , Bi-specific Abs (CHO cells and ExPi293 expressed)
• Skills in mammalian and microbial recombinant protein purification techniques, including Protein A capture, use of multi-modal ligands for selectivity, SEC polishing. Analytical QC: Endotoxin testing , SDS-PAGE.
• Gained hands-on experience in transformation, induction, lysis, and purification processes in a laboratory setting.
• Successfully delivered client project on COVID – 19 semi synthetic conjugated vaccine for process development, scale – up and manufacturing at Anthem Biosciences pvt Ltd.
• Experience in microbial protein purification principles and methods including modes of chromatography,cell lysis, filtration centrifugation, depth filtration, tangential flow filtration.
• Experience in mammalian protein purification including depth filtration, microfiltration, capture step chromatography, viral clearance, polishing step and UF/DF.
• Hands on experience of AKTA chromatography systems using UNICORN software and NGC Chromatography system using chromlab software, and in chromatography column packing.
• Experience in process development scale-up and technology transfer.
• Experience in managing client projects and organizing workflow with group members to meet requirement of project.
• Generate and analyze data, prepare experiments/data for presentation and prepare documents (Development protocols, reports, SOPs including change control, non-conformity handling).
• Experience with installation, operational and performance qualification activities of equipments and instruments.
• Assist in maintaining process development laboratory including general lab up keep, material and equipment inventory, maintenance and organization.
• Experience in use of EPR inventory system (SAP) for project based material ordering, batch no. creation.
• Co-ordinate internal and external activities pertaining to timeline to deliver project successfully.
• Maintaining the equipment and instrument in a state of compliance with effective calibration.
• Actively participated during regulatory audit DCGI.

• Continued process verification (CPV) of batch manufacturing data.
• Batch manufacturing Records data collection and compilation.
• MAb production platform process, Evaluation of Resin Performance, Pressure flow curve test, Determination of Dynamic binding capacity of the resin.
• Estimation of resin compressibility, Determining the breakthrough capacity for the chromatographic media
• Packing and unpacking of columns and tangential flow filtration.
• Resin shelf life establishment of Expired Resin(IEX, Affinity, CEX)
• Understanding of Affinity chromatography,Ion exchange chromatography and hydrophobic interaction chromatography, Buffer preparation.

• Mammalian Expressed - Transtuzumab, Tenecteplase
• Microbial Expressed - GCSF, PEG-GCSF, CpB, Serratiopeptidase, Trypsin, Enterokinase