Experience

Teneobio, Inc.

• United States
• Biotechnology
• 1 - 100 Employee

• Research Associate II, Protein Sciences

  • Apr 2019 - Present



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Scientist II, Process Sciences

  • May 2017 - Apr 2019

  Conjugation and Purification Development• Develop, optimize, and scale-up (~100g) robust conjugation and HIC purification processes for toxicology, pre-clinical, and clinical manufacturing of antibody-drug conjugates (ADCs).• Optimize and execute processes to conjugate and purify critical reagents such as sulfotagged, biotinylated, HRP tagged, and His-Tagged proteins to support existing clinical programs.• Analyze and characterize process intermediates and final product quality using analytical methods such as HPLC SEC, HIC, Reverse Phase, and Spectrophotometry.• Execute high throughput conjugation conditions using Tecan RADCAP liquid handling.• Lead and execute the production of toxicology ADCs.• Contribute in process development documentation such as process description and development reports.• Collaborate regularly with analytical development, Manufacturing, GLP Bioassay development groups.



Bayer Pharmaceuticals

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Scientist

  • Jul 2016 - May 2017

  Process Optimization for a Monoclonal Antibody Product• Evaluated membrane adsorber purification configurations at different flow rates to increase process efficiency and analyzed fractions by HCP ELISA to establish optimal peak cut off.• Supported upstream studies on small-scale reduction model and investigation, which included full train process purification, formulation, sterile bottling, and LIMS sample planning/submission.• Analyzed the stability of GMP process intermediates and drug substance samples via in-house analytical assays and submission to analytical department.• Led and managed a small team to conduct bench scale full train purification processes which included planning, scheduling, sample submission, data analysis and compiling.• Assisted in editing and reviewing internal reports.• Provided training to new contractors and interns.Pilot Scale (200L) Production of Monoclonal Antibody• Executed two GLP 200L development lots as an operator to performing clarification using depth filter, chromatography on AKTA Ready, viral filtration, tangential flow filtration (TFF), and sterile bottling.• Performed tubing assemblies, large scale buffer preparations, and flow kit installation on AKTA ready and method editing on UNICORN.• Aided in the preparation of batch process record documents for purification processes.Clinical Manufacturing Campaign of Monoclonal Antibody• A team member in two clinical manufacturing campaigns executing the isolation and purification of monoclonal antibodies in Phase 1 and Phase 2b where Good Manufacturing Practice was implemented.• Operated large scale bioprocessing equipment and automated control system used in chromatography processes.• Proficient in understanding of manufacturing process, compliance, standard procedure.• Competently executed processes according to SOP and Batch Process Records (BPR). • Assisted and reported to SMEs in purification processes and bottling.

• International Intern

  • Sep 2014 - Aug 2015

  Downstream Process Development of a Protein Therapeutics• Conducted bench-scale experiments to develop downstream purification process for a therapeutic protein which included the use of column chromatography, resin screening, column packing.• Established process intermediates and final product quality using analytical methods such as SDS-PAGE, HCP ELISA, Western Blot, Size Exclusion Chromatography, and Spectrophotometry.• Established optimal elution condition by evaluations of gradient elution and fractionation using various salt concentrations.• Screened 20 different resins for this antibody using scouting method.• Developed appropriate process buffers with various pH and conductivity, required for optimal purification.• Performed further optimization experiments for the developed process.• Compiled a database of purification trains and analytical data from various experiments.• Managed sampling plan, inventory, and submission of process intermediates and final product for submissions through LIMS.• Wrote and presented project results using Microsoft Word, Excel and Power Point.• Scaled-up the developed small-scale process into a pilot scale (200L), purified the protein, and compared its process, intermediates and product quality. Other Supporting Work• Supported a CEX-AEX column sequence switch study by executing purification runs using AKTA (Avant & Explorer) as well as conducting in-house analytical work.• Investigated the root cause of protein precipitation by concentrating a process intermediate material using tangential flow filtration (TFF), turbidity meter, and HCP ELISA.• Performed SDS-PAGE analysis of hundreds of fractions generated from a resin (CEX and AEX) screening study of an antibody.