Summary
Overview
Work History
Education
Skills
Accomplishments
Affiliations
References
Timeline
Generic

Shweta Singh

Tempe,AZ

Summary

Experienced Molecular Biologist with over 5+ year of experience in technology transfer process of cell and gene therapy products. Strong project management skill and desire to achieve success and increase productivity with process improvements. Excellent communication skills with proven track record of leading projects and collaboration with CRO partners and internal teams.

Overview

6
6
years of professional experience

Work History

Senior Scientist (Analytical Scientist III)

Charles River Labs
Memphis, TN
04.2021 - 10.2023
  • Managed the tech transfer process of analytical methods, including qualification, validation (ICH Q2 R1) of analytical methods supporting clinical and commercial products.
  • Authored and reviewed all tech transfer documents BPR, SOPs, validation protocols, tech transfer protocol.
  • Directed and managed the evaluation of the facility transfer process through gap analysis and risk assessment of the client manufacturing process.
  • Collaborated with cross-functional teams to ensure project objectives were met within deadlines.
  • Supervised and provided training and technical support to QC analytical team.
  • Supervised the junior team members and conducted interviews.

Innovation Analyst III

Cognate Bioservices
Memphis, TN
06.2018 - 02.2021
  • Designed and devloped new inhouse assays such as mycoplasma, copy number (Lentiviral or retroviral) and gene expression assay.
  • Trained QC team and monitored results in order to evaluate the inhouse assay capabilities and provide support as needed.
  • Scheduled and performed qPCR analysis of client products, including nucleic acid isolation, purification, and quantitation according to Test Methods
  • Performed other assays such as ELISA, Western Blot, gel electrophoresis as required. Working knowledge of mammalian cell culture including T-cells, NK cells, Neural stem cells using standard cell culture flasks, G-Rex and Quantum Bioreactor
  • Lead laboratory OOS, CAPA, change control or other investigations, as required.
  • Recognized as employee of the month for completion of the project in tight deadline.

Research Associate

Florida Atlantic University
Boca Raton, FL
08.2017 - 05.2018
  • Screened novel bacteria with the best antibiotic profiles from the data produced by more than ~192 undergraduate students during the General Microbiology class.
  • Validated the results using microbiology and molecular biology techniques such as qPCR, sequencing bacterial cell culture, Gram staining, Lactose fermentation, Indole production assay, Catalase assay
  • Assisted in establishing collaboration with chemistry lab for separation of the compound responsible for the possible antibiotic activity using HPLC.
  • Supervised two undergraduate students with designing and establishing the experiments for the direct independent study.

Education

Ph.D. - Integrative Biology

Florida Atlantic University
Boca Raton, FL
08.2017

B.Tech - Biotechnology

Sam Higginbotom Institute
Uttar Pradesh, India
06.2007

Skills

  • Team Leadership
  • Quality management
  • CMC regulatory affairs
  • Flow Cytometry
  • Cell culture
  • Molecular Biology
  • Root cause analysis
  • Quality Control
  • Data analysis
  • Immunostaining
  • Validation Testing
  • Project Planning and Implementation
  • Technical Writing
  • Cross-Functional Teamwork

Accomplishments

The Allied Genetics Conference Travel Award, 2016

  • Awarded by Genetics Society of America and Drosophila

Affiliations

  • Biological Sciences Student representative, FAU, 2014-2015
  • International Student orientation Chair,FAU, 2010-2013

References

References available upon request.

Timeline

Senior Scientist (Analytical Scientist III)

Charles River Labs
04.2021 - 10.2023

Innovation Analyst III

Cognate Bioservices
06.2018 - 02.2021

Research Associate

Florida Atlantic University
08.2017 - 05.2018

Ph.D. - Integrative Biology

Florida Atlantic University

B.Tech - Biotechnology

Sam Higginbotom Institute

Similar Profiles

CREATE PROFILE
Shweta Singh