Summary
Overview
Work History
Education
Skills
Certification
Specialities
Timeline
Generic

Chaya Aruna Babu Kandregula

Grayslake,United States

Summary

A highly motivated toxicologist with extensive experience in performing pre-clinical toxicity studies, conducting risk assessment for medical devices and drafting biological evaluation reports. Organized and dependable candidate successful at managing multiple priorities with a positive attitude and with willingness to take on added responsibilities.

Overview

12
12
years of professional experience
1
1
Certification

Work History

Technical Lead

HCL America Inc
05.2023 - Current
  • Toxicological Risk Assessment of medical devices, Biological evaluation reports in compliance with EU MDR.
  • Sample logging, sample shipment and MAT documentation.
  • Maintained close communication with clients throughout project life cycles for accurate progress reporting and prompt issue resolution.
  • Contributed to positive organizational reputation and credibility within the toxicology community by maintaining active memberships in professional associations and participating in industry events.
  • Assessed risks associated with medical devices.

Technical Lead

HCLTech
01.2021 - 04.2023
  • Biocompatibility GAP Assessment, Drafting Biological evaluation reports, Toxicological risk assessment of Medical devices
  • Analyzed data from pre clinical studies to evaluate medical device extractables safety profiles.
  • Mentored Mechanical engineers in performing GAP assessment (Biocompatibility)
  • Streamlined workflows between departments by coordinating cross-functional efforts during complex projects requiring collaboration among diverse stakeholders.
  • Mentored team members in development, execution, and interpretation of biological evaluation.

Study Director

DILIGENCE BIO PVT. LTD.
12.2017 - 11.2020
  • Preclinical toxicology- Agrochemicals, veterinary products
  • Established standard operating procedures for laboratory processes.
  • Evaluated chemical substances for potential health hazards, leading to improved product safety.
  • Set up and calibrated laboratory instruments and equipment to prepare for testing purposes.

Study Director

Micro Therapeutic Research Labs Private Limited
12.2016 - 10.2017
  • Performed biocompatibility studies for medical devices following ISO 10993 series
  • Prepared study plan and study reports in compliance with OECD-GLP
  • Enhanced study outcomes by designing and implementing comprehensive protocols for preclinical studies.
  • Led a team of researchers efficiently, providing guidance and support to maximize productivity and achieve project goals.

Project Assistant

Anna University
08.2014 - 03.2016
  • Working in Laboratory of Pulmonary medicine, Developing animal models for pulmonary diseases like COPD and Asthma, Assist in drug development and efficacy studies
  • Worked with senior leadership to complete complex projects on time and under-budget.
  • Created and updated records and files to maintain document compliance.
  • Contributed to successful project outcomes by providing comprehensive administrative support to the team.
  • Handled administrative duties, filing, and errands.
  • Researched and analyzed data to support project-related decisions.
  • Provided assistance with preparation of project-related reports, manuscripts and presentations
  • Conducted research to assist with routine tasks and special projects.

Study Scientist

iibat
11.2012 - 08.2014
  • Pre clinical toxicologist - Assist study directors in performing acute and sub acute inhalation, oral and dermal toxicity studies

Education

Master of Science (M.Sc.) - Biotechnology

Dr.V.S.Krishna college, visakhapatnam
01.2011

Skills

  • Toxicological Risk Assessment
  • In-vivo and in-vitro testing
  • 510(k)
  • Biological evaluation
  • GAP assessment
  • PLM Software
  • 10993
  • Agrochemical testing
  • OECD-GLP
  • Respiratory Therapy
  • Inhalation toxicology

Certification

UK ERT - British Toxicology Society (BTS), 10/01/23, 10/01/28

Specialities

  • Toxicological Risk Assessment for medical devices
  • Biocompatibility GAP assessment
  • Biological evaluation plans/reports
  • Supporting regulatory submissions 510(k) FDA
  • Handling Airway mechanics Analyser equipments: Inhalation Exposure System (CH Technologies, USA; EMMS, UK and Scireq, Canada), Whole Body Plethysmography (Emka Technologies)
  • Dose formulation and preparation of doses for various routes of administration as per regulatory guideline.
  • Experience in parenteral route of administration (Subcutaneous, Intravenous, Intraperitoneal).
  • Hands on experience in blood Collection through orbital sinus vein and BAL fluid collection.
  • Hands on experience in performing Necropsy and organ collection.

Timeline

Technical Lead

HCL America Inc
05.2023 - Current

Technical Lead

HCLTech
01.2021 - 04.2023

Study Director

DILIGENCE BIO PVT. LTD.
12.2017 - 11.2020

Study Director

Micro Therapeutic Research Labs Private Limited
12.2016 - 10.2017

Project Assistant

Anna University
08.2014 - 03.2016

Study Scientist

iibat
11.2012 - 08.2014

Master of Science (M.Sc.) - Biotechnology

Dr.V.S.Krishna college, visakhapatnam
Chaya Aruna Babu Kandregula