Summary
Overview
Work History
Education
Skills
Timeline
Generic

Ritu Shrestha

Summary

I`m an emerging scientist worked with renowned pharmaceutical companies like Pfizer, Biomerieux and Seqirus. Adhered to GMP, GLP and cGMP guidelines. Providing all documentation necessary to allow proper accountability and traceability of product in compliance to GDP requirements. Identifying and investigate compliance, environmental, safety, and process deviations while notifying appropriate personnel.

Overview

7
7
years of professional experience

Work History

Senior Technical Operation III

Pfizer (BRD)
11.2021 - Current
  • HEK293 cell cultivation from initial vial thaw, cell splitting, wave bioreactor, transfection, perfusion and harvest using Aseptic techniques
  • Responsible for Electronic Batch Record (eBR) creation, validation, implementation, and review
  • Experience in use of biological safety cabinets, aseptic processes, multichannel pipettes, Vi-cell, pH meter, autoclaving, analytical balances, Delta V, LIMS
  • Responsible for unit operations including setup, execution, and evaluation of GMP operations including shake flasks, waves, bioreactors, transfection and perfusion
  • Aseptic technique, cell counting, culturing mammalian cell lines in shake flasks and/or bioreactors, thawing and freezing cell lines, and determination of cell culture metabolites
  • Perform maintenance and troubleshooting on various types of equipment including BGAs, Vi-cell analysers, bioreactors, PH meters, pre-tube assemblies, tubing welders and hot sealers
  • Ability to prioritize and organize workload to efficiently accomplish departmental goals
  • Experienced in the utilization of Delta V with upload batch, Installation and Inflation of SUB bags, Pressure test, Media charge, inoculation of WAVE and SUM
  • Collaboration with Cross functional team on compiling and presenting data, CAPA determination
  • Responsible for conducting training for new team member and singing off on OJT.

Bioprocess Technician IV (Upstream)

Pfizer
04.2020 - 04.2021
  • Part of Pfizer's pilot project of revolutionizing gene therapy medicine for DMD using HEK293 and rAAV from clinical trial materials, cell runs engineering rums to PPQs
  • Responsible for Upstream process development activities of HEK293 cell line from media preparation, Vial thaw to 2000L SUB expansion following cGMP and GMP regulation through use of SOP and batch records
  • Conducting biosafety training and Actively Caring session in NEO
  • Execute batch activities in DMD upstream in electronic batch records
  • Responsible for the operating and troubleshooting single use bioreactors
  • Experience in use of biological safety cabinets, aseptic processes, pipettes, Vi-cell analyser, BGA, LIMS and SAP
  • Experienced in the utilization of Delta V, LIMS, EBR and SAP
  • Responsible for updating and improving SOP documentation for DMD upstream.

QC Microbiology Analyst I (Contract)

BioMerieux
11.2019 - 02.2020
  • Performing routine tests by using serial dilution technique, spectrophotometer per standard operating procedures
  • Conduct Bioburden test (Plate count and Membrane filter), Conductivity test, viable and nonviable environmental monitoring, sampling throughout facility, aseptic processing areas and classified manufacturing areas
  • Documents all test results in compliance with procedures and GDP requirements
  • Responsible for inventory management and ordering/stocking of laboratory supplies
  • Executes laboratory, nonconformance, and CAPA investigations as assigned by management in compliance with procedures
  • Recommends revisions to standard operating procedures and assists in implementation of revisions
  • Investigate and complete EOOS reports for excursion events in the lab
  • Performed routine tests under GMP and cGMP guidelines.

Quality Control Analyst I (Contract)

Seqirus
05.2017 - 11.2017
  • Archival and Validation of documentation, and support teams on key deliverable with Process 3.0 QC Planner on sampling completion and scheduling as needed
  • Ensures collaboration of with other functions and departments on changes, CAPAs and Atlas documentation revisions
  • Perform bioassay testing such as BCA and BI for Validation purposes
  • Generation, collection, interpretation, and summarization of data from experiments using Empower and LIMS system.

Education

Master’s in Business Administration -

Strayer University
Raleigh, NC

BS in Biology -

Southern Illinois University Edwardsville
Edwardsville, IL

Skills

  • Proficient with Microsoft Office, EXCEL, Outlook, PowerPoint, LIMS, Share Point, TrackWise, ELN, Empower2, Citrix, SAP, Delta V, 5S, Grade A/B aseptic gowning, aseptic technique, Six-Sigma, BSC Hood, serial dilutions, autoclave, inventory Axis 360, welder, sealers, EBR, Vi-cell, Blood Gas Analyser, pH probes and DO probes

Timeline

Senior Technical Operation III

Pfizer (BRD)
11.2021 - Current

Bioprocess Technician IV (Upstream)

Pfizer
04.2020 - 04.2021

QC Microbiology Analyst I (Contract)

BioMerieux
11.2019 - 02.2020

Quality Control Analyst I (Contract)

Seqirus
05.2017 - 11.2017

Master’s in Business Administration -

Strayer University

BS in Biology -

Southern Illinois University Edwardsville

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Ritu Shrestha