Vedanta Malhoe

• Led validation and launch of Illumina's TruSight 500 Solid Tumor and Archer Myeloid and Pan-Heme NGS panels
• Optimized procedures for company's first Next Generation Sequencing pipeline, including FFPE and bone marrow specimen extractions, DNA & RNA quantification methodologies, and sample preparation
• Performed and streamlined Library prep
• Procedures (both automated and manual)
• Collaborated with vendors and third-party genomics consultants for validation reviews, method and instrument troubleshooting, and data presentation
• Led development of SOFT LIS Molecular suite to facilitate in-house genomic testing
• Developed CAP/CLIA documentation, including specimen handling/rejection forms, instrument verification records, and training records
• Authored, reviewed, and edited clinical SOPs
• Performed Prosigna Breast Cancer Prognostic Assay
• Trained, mentored, and supervised new technologists on high complexity tests (NGS workflows) and supervised 6-month and annual competencies
• Validation of Pillar Onco Reveal MPN panel (focusing on MPL, JAK2, and CALR variants)
• Responsible for proforma publication and presentation for new testing including liquid biopsy and UGT1A1 variant detection
• • Contributed to the validation and onboarding of the Quantidex qPCR-based BCR-ABL IS testing for CML detection and treatment monitoring

Selected Highlight: Led onboarding of first in-house genomic testing capabilities at Florida Cancer Specialist's Next Generation Sequencing (NGS) laboratory, enabling physicians at nearly 100 locations to make faster diagnoses of wide range of cancers.

• Supported cosmetic/food natural product development from algae as Senior Analytical Chemist
• Determined algae media nutrient content by flow injection analysis (FIAlab) to monitor dosing and nutrient uptake
• Conducted QC analysis for product release, in-process, and shelf-life stability testing, following cGMP guidelines for method documentation and COA preparation
• Authored QC instrument verification and product testing SOPs
• Performed UPLC testing on final product to detect preservatives in cosmetic products
• Conducted analytical equipment qualifications (IQ/PQ) for analytical balances, centrifuges, and UV-VIS spectrophotometer

Selected Highlight: Supported quality function of new product plant by generating timely COAs to ensure shipment.

• Managed the flow of high-volume biochemical samples to support product development R&D and process optimization for commercialization.
• Developed and validated ELISA microcystin toxin screening method and a protein phosphatase confirmation assay for quality assurance testing of the final product.
• Optimized a lysozyme extraction method for high-value pigment extraction from resistant biomass to support process development operations.
• Served as a technical advisor on a multi-disciplinary team focusing on downstream process optimization of algae pigment, reviewed test plans, and participated in RCA sessions.
• Characterized carbohydrate content in released polysaccharide as a potential cosmetic product in new algal strains.

• Developed and validated high-throughput enzyme kinetics assays to monitor activity changes corresponding to protein levels, mutations in fermentation genes, or enzyme inactivation by post-transcriptional modifications
• Trained and supervised incoming lab assistants to maximize department bandwidth for sample processing
• Led the "Method Harmonization" project in collaboration with the company's European division and Reliance Industries, aiming to standardize enzyme assay test methods at both sites.

• Supported research for Algenol's proprietary "Direct to Ethanol" process from hybrid, blue-green algae
• Responsible for plating, media prep, PCR for molecular transformation, and small-scale cultivation of cyanobacterial proprietary strains
• Developed and optimized Western blot methods to monitor protein levels in key fermentation pathways for ethanol production in new transformants.