Jyotsna

Biospecimen Operations professional with 7+ years of hands-on experience managing sample collection, processing, biobanking, and chain-of-custody across cell and gene therapy, diagnostics, and translational research programs. Deep expertise in specimen handling (blood/serum/plasma/oral fluid/urine), cryogenic and cold-chain storage, LIMS administration, and domestic/international shipment coordination in GCP/GMP/GLP-regulated environments. Scientific foundation (MDS, BDS in Oral Pathology & Microbiology) combined with data analytics skills (Python, SQL, Tableau) supports accurate specimen tracking, inventory reconciliation, and regulatory documentation.

Trusted partner to Quality, Manufacturing, Clinical Operations, and CRO/vendor teams, ensuring biospecimen integrity from collection through disposition.

Supply Chain Manager / Patient Logistics Manager - Arcellx (acquired by Gilead Sciences, 2026) - Redwood City, CA

(2023-04 - 2026-05)

Arcellx was a late-stage clinical biotechnology company developing differentiated cell therapies for patients with cancer; the company was acquired by Gilead Sciences in 2026. Held central responsibility for patient sample chain-of-custody, cold-chain handling, and specimen logistics supporting Phase 1 and registrational cell therapy programs.

• Managed vein-to-vein chain-of-custody for patient materials across 120+ patients and multiple clinical sites, achieving 100% cold-chain compliance and zero chain-of-custody (COC) deviations.
• Coordinated patient sample collection, JIT packaging, and temperature-controlled shipments (2–8°C and LN₂ cryogenic), aligning manufacturing, QA batch release, and clinical operations to maintain reliable specimen integrity.
• Supported onboarding and activation of 15+ clinical sites globally, delivering hospital training on sample handling, packaging, and labeling procedures.
• Developed and maintained SOPs and work instructions governing sample handling and chain-of-custody, improving operational consistency and regulatory compliance.
• Ensured lot genealogy, traceability, and documentation accuracy across all stages of sample handling, maintaining complete audit-ready records for regulatory inspections.
• Managed material quality documentation including Certificates of Analysis (CoA), Certificates of Conformance (CoC), and TSE/BSE declarations supporting material classification and GMP compliance.
• Led inventory reconciliation across physical inventory and WMS systems, resolving discrepancies and driving improvements in accuracy and visibility.
• Provided critical support for computer system validations (CSV) and drove quality event investigations including root cause analysis and CAPA development.
• Monitored and reported logistics KPIs including cycle time and cold-chain compliance to support capacity planning.

Senior LIMS Lab Analyst – Translational Development - Bristol Myers Squibb - Redwood City, CA

(2022-09 - 2023-03)

Embedded within the Translational Development group at BMS, supporting biospecimen data systems, sample operations, and LIMS infrastructure to enable translational research and clinical biomarker programs.

• Managed 1,000+ commercial human tissue and peripheral blood samples within the LIMS system, ensuring full traceability, data integrity, and accurate record-keeping.
• Played a pivotal role in the enhancement and customization of the RWC LIMS system, gathering user requirements, designing manifests/data entry forms, validating forms, and engaging in buildout discussions through user acceptance testing (UAT).
• Coordinated day-to-day sample tracking and management for the Translational Development team, overseeing sample inventory and shipping to CROs including preparation of manifests.
• Maintained sample storage infrastructure, guaranteeing proper storage conditions, organization, and chain-of-custody documentation for all samples.
• Contributed to quarterly dashboard updates on sample disposition, covering both location and status for senior stakeholder reporting.
• Provided periodic projections of sample inventory and effectively managed timelines for sample delivery and shipping to external partners and CROs.

R&D Scientist II – Biospecimen Coordinator - Thermo Fisher Scientific - Fremont, CA

(2022-02 - 2022-08)

Supported immunoassay development, sustaining, and product release through biospecimen coordination across 30+ research studies.

• Conducted collection and handling of biospecimens (human blood, serum, plasma, oral fluid, urine) for 30+ projects supporting immunoassay development, applications, sustaining, and product release.
• Executed retrieval, aliquoting, labeling, and shipment of samples from the biobank to internal and external stakeholders including customers, vendors, CROs, and reference labs.
• Cataloged patient samples utilizing biobanking software and managed specimen data gathered from external vendors and partners, maintaining full traceability and data integrity.
• Maintained the overall organization of the biobank, ensuring proper sample organization, freezer configurations, temperature monitoring, and chain-of-custody documentation.
• Provided support for customs paperwork generation and logistics for shipping reagents and samples to international testing sites across 5+ countries, ensuring regulatory compliance.

Medical Technologist - Abbott Laboratories - Santa Clara, CA

(2021-04 - 2022-02)

Supported product development, validation, and verification activities for hematology and diagnostics instrumentation in a regulated laboratory environment.

• Collected, analyzed, and interpreted results from diverse body fluid samples, directly supporting product development and validation activities.
• Verified and validated established procedures on hematology instrumentation, certifying alignment with design inputs and regulatory requirements.
• Executed quality control studies, ensuring the accuracy of clinical data and troubleshooting experiments and instrumentation as required.
• Maintained inventory levels and ensured compliance with Good Laboratory Practices (GLP) and proper documentation practices.

Biorepository Technician & Training Coordinator - Guardant Health - Redwood City, CA

(2020-08 - 2021-04)

Managed laboratory biorepository operations and led training coordination for a high-volume clinical genomics laboratory.

• Managed end-to-end laboratory sample processes using the LIMS database, encompassing sample intake, accessioning, processing, and disposition.
• Proficiently verified and assessed acceptability of incoming samples, prepared samples for testing, and resolved discrepancies in collaboration with client services and analytical teams.
• Operated, maintained, and troubleshot laboratory equipment in adherence to SOPs and GLP requirements; documented deviations using Nonconforming Event Reports (NERs).
• Monitored and recorded freezer and refrigerator temperatures, maintaining sufficient inventory of laboratory stock for daily operations.
• Trained and evaluated competency of new laboratory personnel across all shifts, serving as primary contact throughout onboarding.

Oral Pathologist & General Dentist - ADS Dental Clinic / Secunderabad Dental Hospital - India

(2009-06 - 2015-05)

Performed histological diagnosis and maxillofacial pathology evaluations; published research on oral cancer biomarkers, building a foundation in specimen analysis and laboratory diagnostics.

Executive MBA - Quantic School of Business and Technology

Master of Dental Surgery - Oral Pathology & Microbiology - Mamata Dental College, India (2010-06 - 2013-04)

Bachelor of Dental Surgery - Army College of Dental Sciences, India (2003-10 - 2009-05)