Summary
Overview
Work History
Education
Skills
Awards
Activities
Timeline
Generic

SHWETA SINGH

San Antonio,TX

Summary

Experienced Molecular Biologist with a strong background in quality control and over 5 years of expertise in the technology transfer of cell and gene therapy products. Strong project management skills 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. Quality Control Scientist with robust background in pharmaceutical and biotechnological industry. Specialized in performing laboratory tests to produce reliable and precise data for product quality assurance, demonstrating strong analytical and problem-solving skills. Proven track record of improving processes to maintain compliance with regulatory requirements and standards while ensuring optimal product quality. Known for fostering collaborative team environments for efficient project completion.

Overview

7
7
years of professional experience

Work History

Quality Control Scientist IV

Scorpius Biomanufacturing
San Antonio, TX
04.2024 - Current
  • Performed daily quality control inspections on finished products to ensure compliance with established standards.
  • Conducted regular tests and analyses of raw materials, in-process ingredients, and finished goods to verify product specifications.
  • Monitored production processes for adherence to cGMP guidelines and regulatory requirements.

Analytical Scientist III

Charles River Labs
Memphis, TN
06.2021 - 01.2024
  • Led the technology transfer process for analytical methods, including qualification, ICH Q2 R1 validation, and stability program implementation for clinical and commercial products
  • Authored and reviewed tech transfer documents, including stability study protocols, sampling plans, material specifications, equipment impact assessments, SOPs, Validation protocols and PPQ documents
  • Proficient in designing studies, analyzing data, and effectively communicating results in written and oral formats
  • Providing support and oversight on the impact assessment process for non-conformances and out of specifications (OOS)
  • Collaborated with cross-functional teams to ensure project objectives were met within deadlines
  • Supervised and provided training and technical support to QC analytical team
  • Coached new junior employees by providing one on one training and guidance to support their professional growth
  • Led interview processes for prospective hires within the analytical sciences team
  • Skilled in navigating and applying cGMP, along with the intricate guidelines and regulation of 21CFR Part 211, FDA, EMA, ICH, USP and EP, specifically tailored to the quality control of biologic and cell therapies

Innovation Analyst III

Cognate Bioservices
Memphis, TN
06.2018 - 05.2021
  • Designed and developed new in-house assays such as mycoplasma, copy number (Lentiviral or retroviral) and gene expression assay
  • Trained QC team and monitored results to evaluate the in-house 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, Endotoxin as required
  • Working knowledge of mammalian cell culture including T-cells, NK cells, Neural stem cells using standard cell culture flasks
  • 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

  • Client Relationship Management
  • Quality management
  • QPCR and ELISA
  • Flow cytometry
  • Cell culture
  • Molecular Biology
  • Root cause analysis
  • Quality Control
  • Data analysis
  • Endotoxin
  • Validation Testing
  • Master control
  • Technical writing
  • Cross-functional teamwork

Awards

  • The Allied Genetics Conference Travel Award, Genetics Society of America and Drosophila, 2016
  • Charles E Schmidt College of Science Dissertation of the year Award, FAU, 2015
  • Graduate Professional and Student Association Travel Award, FAU, 2015
  • Vincent Saurino Fellowship for Graduate Student in Biological Sciences Award, FAU, 2015

Activities

  • Biological Sciences Student representative, FAU, 2015
  • International Student orientation Chair, FAU, 2013
  • Society of Genetics & Plant Breeding and Seed Science & Technology Member, 2007

Timeline

Quality Control Scientist IV

Scorpius Biomanufacturing
04.2024 - Current

Analytical Scientist III

Charles River Labs
06.2021 - 01.2024

Innovation Analyst III

Cognate Bioservices
06.2018 - 05.2021

Research Associate

Florida Atlantic University
08.2017 - 05.2018

Ph.D. - Integrative Biology

Florida Atlantic University

B.Tech - Biotechnology

Sam Higginbotom Institute

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