SUNKU SRILATHA
Hyderabad
Summary
Accomplished invitro ADME Toxicologist scientist with extensive experience in cell culture, assay execution and GLP compliance. Proven track record in developing and validating protocols, maintaining cell lines and leading a scientific team’s. Expertise in permeability assays, bio-transformation assays, and toxicology assays.
Overview
13
13
years of professional experience
Work History
Associate Scientist in the DMPK Department (ADME)
Aryastha Life Sciences
08.2024 - Current
- Execute the Protocols and costing sheets for the cell culture, conserved inventory.
- Trained on Waters TQ-S mass spectrometer for Bio analytical applications.
- Validated protocols for key physicochemical assays, including Log D, thermodynamic solubility, kinetic solubility, and cell-based solubility.
- Established and validated the protocols for Plasma stability, Plasma protein binding by Ultra centrifuge method, microsomal stability.
- Validated absorption assay protocols using Caco-2 cell line to assess permeability and drug transport.
- Prepared and maintained a reliable Caco-2 cell bank.
Associate Scientist in the DMPK Department (ADME)
Syngene Scientific Solutions
07.2023 - 08.2024
- Developed and implemented the Permeability assay protocol utilizing the Biomek i7.
- Oversaw the maintenance of Caco-2, MDCK-MDR1, MDCK cell lines, and primary hepatocytes.
- Conducted Permeability and Bio-transformation assays.
- Compiled, analyzed, and reviewed experimental reports.
- Managed the resource materials for the cell culture division.
- Validated 96 well plate protocol for hepatocyte stability to support high throughput screening.
- Trained team members on the departmental activities.
Senior Research Associate in the DMPK Department (ADME)
Aragen Life Sciences
08.2021 - 06.2023
- Executed absorption and bidirectional transport assays on Caco-2, MDCK-MDRI, MDCK WT Cell lines.
- Executed the CYP induction assay using plateable hepatocytes to evaluate drug mediated enzyme regulation.
- Executed uptake and efflux transport assays targeting OATP1b1, OATP1b2, BSEP.
- Performed kit based assays including Herg binding assay, PXR activation assay to evaluate cardiotoxicity and nuclear receptor interactions.
- Performed the invitro cytotoxicity assays on HepG2 cell line for early toxicity screening.
- Maintained and subcultured a range of cell lines including Caco-2, MDCK MDR1, MDCK WT, HepG2, BALB/c 3T3, L5178Y TK+/- cell lines.
- Maintained a GLP compliant environment in the cell culture lab.
- Prepared SOP and SEP to support regulatory compliance and consistency in study execution.
- Prepared Study plans, managed amendments and recorded deviations in compliance with regulatory standards.
- Prepared Study reports, performed data review and analysis to support scientific conclusions.
- Communicated with the clients on the progress of ongoing studies.
- Executed AMES test protocol to evaluate the genotoxicity of test compounds in accordance with regulatory guidelines.
- Executed Phototoxicity assay utilizing BALB/c 3T3 cell lines to assess compound safety under light exposure.
- Executed Mouse Lymphoma assay using L5178Y TK+/- cell lines to assess forward gene mutation frequency.
- Validated the Invitro skin irritation and corrosion assay in accordance with the regulatory guidelines.
Study Director in Genetic Toxicology
Sipra Labs Ltd
01.2020 - 06.2021
- Oversaw assay design and execution while monitoring project progress to ensure alignment with scientific and client objectives.
- Coordinated with the Head of Department to ensure proper execution of assays in alignment with the project goals.
- Supervised and provided mentorship to team members to support their technical and professional development.
- Validated in vitro chromosomal aberration and micronucleus assays in accordance with OECD guidelines for genotoxicity assessment.
- Conducted slide-based screenings to assess morphological changes and cytotoxic effects.
Study Director/Research Scientist in Genetic Toxicology
RCC Laboratories India Private Limited
10.2013 - 12.2020
- Responsibilities included ensuring compliance with Good Laboratory Practices (GLP), planning, execution, analysis, and reporting of studies for clients.
- Acted as a point of contact for clients, delivering timely updates on project status and addressing inquiries.
- Mentored the team on genetic toxicology assays while facilitating scientific discussions among team members.
- Delivered client reports within the defined Turnaround Time (TAT), ensuring accuracy and timeliness.
- Conducted slide-based screenings to assess morphological changes and cytotoxic effects.
- Executed AMES test protocol to evaluate the genotoxicity of test compounds in accordance with regulatory guidelines.
- Executed Chromosomal Aberration studies to evaluate structural chromosomal damage.
- Executed Micronucleus assay in mice to detect the chromosomal damage in bone marrow erythrocyte.
- Executed Mouse Lymphoma assay using L5178Y TK+/- cell lines to assess forward gene mutation frequency.
- Validated the Invitro skin irritation and corrosion assay in accordance with the regulatory guidelines.
- Executed BCOP test using excised bovine corneas to evaluate eye irritation and corrosivity of chemical compounds.
- Microbiological Monitoring/ Tests related to Animal Facilities as per ISO guidelines.
- Microbiological Analysis of Food and Water as per ISO guidelines.
- Maintained and Sub cultured the Bacterial strains, L5178Y TK+/-, BALB/c 3T3 cell line.
Analyst in Immunology and Biochemistry Department
Tapadia Diagnostics
08.2012 - 10.2013
Education
Masters of Science - Biochemistry
Osmania University
HyderabadBachelor of Science - Biotechnology
Osmania University
HyderabadIntermediate -
St. Ann's Junior College
HyderabadSSC -
Vignan High School
HyderabadSkills
- Cell line handling and Maintenance
- Preparation of SOP, SEP, outline protocols
- Franz Diffusion cell
- Biomeck
- Waters TQ-S micro
- Victor Nivo
- Cell countess
- Spectrophotometer
Accomplishments
- Established protocol on the automation i.e., Biomek i7 for the permeability assays.
- Awarded as Outstanding achiever for the year 2023.
Disclaimer
I hereby declare that the foregoing information is correct to the best of my knowledge and belief. I have not suppressed any material fact or factual information in the above statement.
Training
- GLP- the Quality system for Non-Clinical studies OECD Principles on GLP by Ms. Iris Wutchrich, QA Consultant.
- In vitro and In vivo Mutagenicity Studies by Dr. G. P. Meshram, Joint Director, Ministry of Defence; Govt. of India Defence Research and Development Organization (DRDO).
- Role of Regulatory toxicology and GLP in Drug Discovery and Development by National Institute of Pharmaceutical Education and Research 2020.
- Certificate course on Drug Metabolism and Pharmacokinetics conducted by Society for the Study of Xenobiotics (SSX) India 2023.
Audits Faced
- Three main GLP and six surveillance audits by NGCMA (National GLP Compliance Monitoring Authority, Govt. of India) at RCC India Private Limited, one at Sipra Labs Ltd.
- AAALAC audit at RCC India Private Limited.
- One GLP audit by NGCMA (National GLP Compliance Monitoring Authority, Govt. of India) at Aragen Life Sciences.
Timeline
Associate Scientist in the DMPK Department (ADME)
Aryastha Life Sciences
08.2024 - Current
Associate Scientist in the DMPK Department (ADME)
Syngene Scientific Solutions
07.2023 - 08.2024
Senior Research Associate in the DMPK Department (ADME)
Aragen Life Sciences
08.2021 - 06.2023
Study Director in Genetic Toxicology
Sipra Labs Ltd
01.2020 - 06.2021
Study Director/Research Scientist in Genetic Toxicology
RCC Laboratories India Private Limited
10.2013 - 12.2020
Analyst in Immunology and Biochemistry Department
Tapadia Diagnostics
08.2012 - 10.2013
Masters of Science - Biochemistry
Osmania University
Bachelor of Science - Biotechnology
Osmania University
Intermediate -
St. Ann's Junior College
SSC -
Vignan High School
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