Somia Das
Scientist And Study Director
Panchkula,HR
Summary
Results-driven preclinical research specialist with over three years of experience in conducting acute and chronic toxicity studies Biocompatibility evaluation and pharmacokinetic assessment for drugs, vaccines, and medical devices. Expertise includes a diverse range of animal models, such as rodents, rabbits, dogs, and non-human primates, to effectively assess systemic exposure and potential toxicity. Proficient in developing comprehensive study plans and reports that adhere to regulatory standards and Good Laboratory Practices (GLP), while creating study synopses that streamline analysis and approval processes for stakeholders. Additionally, a dedicated mentor contributing to training programs that enhance team knowledge of study protocols and methodologies, alongside previous experience as a Subject Matter Expert in Biology at Chegg India Pvt. Ltd., providing in-depth support to students worldwide.
Overview
3
3
Language
3
3
years of professional experience
Work History
Scientist & Study Director
AAL Biosciences Research Private Limited
07.2025 - Current
- Conduct all experimental procedures in accordance with ISO/IEC 17025 requirements for laboratory competence and method validation.
- Ensure full adherence to OECD GLP principles, maintaining data integrity, traceability, and proper documentation.
- Follow institutional SOPs, regulatory guidelines, and ethical requirements for the use of laboratory animals.
- Performing acute, systemic toxicity studies for pharma products, and biocompatibility studies of medical devices.
- Ensure humane handling, housing, and monitoring of animals per OECD, CCSEA, and AAALAC.
- Work closely with veterinarians to manage animal health, and implement humane endpoints.
- Assist in the preparation for external audits by NABL, MD40, A2LA, and support technical and management teams during audit interactions.
- Ensure all study records, SOPs, equipment logs, and raw data are inspection-ready.
- Perform pre-audit checks to identify gaps, and coordinate corrective actions.
- Maintained laboratory equipment and ensure compliance with safety regulations and quality standards.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab settings.
Study Director
Palamur Biosciences Private Limited
01.2024 - 06.2025
- Led acute toxicity studies in various species, including dogs, pigs, minipigs, and non-human primates, employing multiple administration routes to evaluate the immediate adverse effects of investigational compounds.
- Conducted Pharmacokinetics studies, Toxicokinetics studies, Dermal Toxicity Studies, Palatability Studies, Safety Pharmacology studies, Regulatory, Safety & Efficacy of various medical devices studies.
- Executed Maximum Tolerated Dose (MTD) toxicity studies in dogs, swine and non-human primates.
- Conducted repeated dose toxicity studies in dogs, swine and non-human primate.
- Directed efficacy and safety studies of biologicals and vaccines in dogs and non-human primates by covering various routes.
- Trained personnel with respect to study conduct and OECD principles of GLP.
- Participated in all in-house/external trainings.
- Prepared study related SOPs and formats.
- Coordinated with the person responsible for calibration / validation / AMC / PMC activities.
- Prepared study synopsis to meet sponsor’s requirement for designing the study.
- Prepared comprehensive study plan and detailed study report with adherence of guidelines and in house SOPs.
- Prepared FORM Bs for new study protocols, facilitating their submission to the Institutional Animal Ethics Committee (IAEC) and the Committee for Control and Supervision of Experiments on Animals (CCSEA) for requisite approvals.
- Prepared FORM A for the registration of new facilities, ensuring compliance with CCSEA and other regulatory bodies.
- Presented and defended study protocols in numerous IAEC and Institutional Biosafety Committee (IBC) meetings, addressing ethical and scientific queries to obtain necessary approvals.
- Successfully defended audits in dog, swine and non-human primate facilities, demonstrating adherence to standard of animal breeding and husbandry and study conduct.
- Contributed to handling multiple projects by collaborating with business development team and sponsor.
Study Personnel
Palamur Biosciences Private Limited
03.2023 - 01.2024
- Participated in dose administration via oral (gavage, tablet and capsule administration), intravenous bolus and infusion, intramuscular, subcutaneous, intrathalamic, intradermal, ocular, intranasal routes.
- Assisted in blood collection and performed centrifugation with multiple timepoints.
- Captured raw data following the ALCOA principle.
Subject Matter Expert
Chegg India Private Limited
09.2021 - 03.2023
- Advised students globally on Biology topics and addressed their academic questions.
Education
Post Graduate Diploma - Animal Welfare
Indira Gandhi National Open University
Delhi, Inida01-2026
FELASA accredited course 052/15 – certificate course in Laboratory Science - Laboratory Animal Science (Function A, B, C and D)
Tamil Nadu Veterinary And Animal Science University (TANUVAS)
Tamil Nadu07-2024
Master of Science - Molecular Biology and Biotechnology
Tezpur University
Assam01-2021
Bachelor of Science - Zoology (Hons.)
University of Calcutta
Kolkata, India01-2019
Skills
Conduct of Pre-clinical studies
SOP, Study plan and study report development
Laboratory equipment operation
Regulatory compliance
Animal Welfare and handling
Self-directed and motivated
Team collaboration
Affiliations
Lifetime member, Laboratory Animal Scientist Association (LASA), India.
Hobbies
- Cooking
- Swimming
- Travelling
- Exercise and fitness
Timeline
Scientist & Study Director
AAL Biosciences Research Private Limited
07.2025 - Current
Study Director
Palamur Biosciences Private Limited
01.2024 - 06.2025
Study Personnel
Palamur Biosciences Private Limited
03.2023 - 01.2024
Subject Matter Expert
Chegg India Private Limited
09.2021 - 03.2023
Post Graduate Diploma - Animal Welfare
Indira Gandhi National Open University
FELASA accredited course 052/15 – certificate course in Laboratory Science - Laboratory Animal Science (Function A, B, C and D)
Tamil Nadu Veterinary And Animal Science University (TANUVAS)
Master of Science - Molecular Biology and Biotechnology
Tezpur University
Bachelor of Science - Zoology (Hons.)
University of Calcutta