Scientist, Quality & Regulatory

Vamshi Renduchintala

Pleasanton, California ****************@*****.*** +1-408-***-****

SUMMARY

Extensive experience in molecular diagnostics, specializing in tech transfer, assay optimization, and regulatory compliance while streamlining workflows and manufacturing processes. Additionally, I continually refine my skills in Python, SQL, and other data tools to effectively address real-world business challenges. EDUCATION

University of Illinois at Urbana-Champaign September 2017 Bachelor of Science in Chemical and Biomolecular Engineering EXPERIENCE

Bio - Rad Hercules, CA

Quality Analyst June 2025 - Present

● Conducted Post Market Performance activities for Northern California product lines (D-10 Hemoglobin Testing System, D-100 Hemoglobin Testing System, VARIANT II/Turbo, BioPlex 2200 MultiPlex Analyzer, CFX Real-Time PCR and QXDx Digital Droplet PCR) meeting 100 % of deadlines for regulatory filing

● Authored Literature Search Protocols and Reports to assess scientific validity, safety, and performance of IVDR certified product lines, identifying compliance gaps and post-market clinical performance trends to support regulatory submissions

● Leveraged Scientific Validity findings alongside Clinical Performance data sourced from internal studies and External Quality Assessment Services (EQAS) to ensure product lines maintained compliance with IVDR requirements, contributing to post-market surveillance reporting

● Investigated root cause of a bulk resin leak on the D-100 Hemoglobin Testing System, testing 75 HPFs across multiple instruments and evaluating system pressure readings, prefilter integrity, chromatogram outputs, and inlet/outlet resin presence under microscopy, to eliminate resin contamination risk

● Operated Bio-Rad's High Performance Liquid Chromatography (HPLC) instruments in the Diabetes product line, supporting large-scale HbA2 standardization study to ensure accurate and consistent quantification of HbA2 levels across instrument platforms in alignment with international reference standards CriticalRiver Pleasanton, CA

Consultant April 2025 - June 2025

● Contributed to end-to-end data pipelines and ETL workflows to ingest, clean, and transform complex assay and compound datasets for client’s (Septerna) drug discovery platform, enabling reliable downstream analysis across research teams

● Served as the primary scientific liaison between CriticalRiver and Septerna, translating biological and pharmacological context into precise technical requirements to ensure data solutions aligned with client’s objectives Biocare Medical Concord, CA

Product Design & Documentation Associate April 2024 – August 2024

● Conducted State of the Art and Scientific Validity Literature Search Reviews for Somatostatin Receptor 2 (SSTR2), PGP9.5, and Steroidogenic Factor 1 (SF-1) IVDR monoclonal and polyclonal antibodies, evaluating the current knowledge base, identifying research gaps, and establishing scientific validity for their diagnostic and clinical relevance

● Conducted Analytical Performance and Clinical Performance Literature Search Reviews for SF-1, setting technical specifications for clinical studies per IVDR requirements, based on expected sensitivity and specificity percentages of antibody to detect SF-1 analyte expressed by Adrenocortical Carcinoma

● Revised design documents in support of product implementations and discontinuations, maintaining clear communication and documentation standards.

● Performed technical document reviews, including QC test records, antibody/reagent data sheet revisions, IHC

(immunohistochemistry) slide grading forms, product labeling, SOPs, and other design input/validation/output documentation, adhering to cGMP requirements

● Trained in IHC assay execution across multiple automated staining platforms, including Leica Bond, Ventana, Intellipath, and Oncore Pro IHC

● Supported senior scientist in SSTR2, SF-1 and PGP9.5 IHC assay validation activities, including slide preparation, reagent handling, and results documentation for quality and regulatory filing

● Developed automated scripts using Python to streamline the Scientific Validity Literature Search Review process, reducing manual review time by 50%.

● Assisted IT with integrating a data pipeline, using Pandas, SQL and PostgreSQL to scrape, organize, store and query large volumes of clinical literature data, supporting the technical evaluation of diagnostic antibodies such as Somatostatin Receptor 2 (SSTR2) and Steroidogenic Factor 1 (SF-1).

● Used PLM tool PolicyTech to support documentation management and regulatory compliance efforts. Cepheid Sunnyvale, CA

Scientist February 2021 – February 2023

● Supported New Product Introduction (NPI) initiatives for Xpert® Xpress CoV-2/Flu/RSV, Xpert® Xpress MVP, Xpert® Xpress Strep A, Xpert® Xpress CoV-2 Plus, and Xpert® HCV by coordinating and contributing to cross-functional activities across R&D, Manufacturing, and Quality teams to ensure seamless transfer of assays from development to production, meeting all deadlines

● Handled variety of sample types in Biosafety Level 2 (BSL-2) laboratory, including viral, cellular and blood borne pathogens like Covid, Flu, MTB, Hep B, Hep C, HIV, Norovirus, and more

● Managed the assembly of initial product models in a cGMP manufacturing environment, and contributed to Bills of Materials

(BOMs), Standard Operating Procedures (SOPs), Work Instructions, and test sheets essential for constructing a final assay

● Assisted Senior Scientists to establish technical specifications for assay manufacturing, conduct data analysis and present conclusions from experiments, and using Good Documentation Practice (GDP) composed documentation vital for regulatory submissions for In Vitro Diagnostic (IVD) products

● Further experience with Good Laboratory Practice (GLP), ddPCR, DNA/RNA extraction, nucleic acid amplification and other molecular biology techniques to run Test Method Validations, Process Validations, and other laboratory experiments as needed

● Utilized Agile for document control, streamlining the development and revision of technical documents to ensure compliance with regulatory standards and facilitate the product's lifecycle from its initial concept through design, development, production, and discontinuation when necessary

● Conducted testing and prepared documentation for the efforts of optimizing the formulation of SPC, EZR and TSR beads used in Xpress Strep A assay, minimizing wasted material and saving up to $300,000

● Employed proprietary Cepheid instrument Beadulator to manufacture and assess the size distribution of lyophilized beads, ensuring consistency and uniformity in particle size and providing critical insights into the bead formulation's performance

● Used Vortex Mixer to homogenize and blend bead formulations, guaranteeing uniform distribution of materials and optimizing the formulation's stability

● Collaborated with R&D, Quality Assurance, Quality Control and Planning Departments to troubleshoot technical issues across the product lifecycle, streamline manufacturing processes, ensure compliance with regulatory standards such as FDA QMS and ISO 13485, and champion Kaizen business policy

● Resolved inconsistent fluorescence signal outputs in diagnostic assays by collaborating with R&D and Quality Assurance teams to identify root causes such as reagent degradation during storage, optimizing storage conditions and stabilizer concentrations to improve assay performance and consistency

● Calibrated GeneXpert Omni instruments as part of quality assurance for diagnostic assays, aligning the instrument outputs with standardized controls, maintaining the reliability and accuracy of diagnostic results in line with regulatory requirements

● Collaborated with teams through Teams and Zoom for cross-departmental project discussions.

● Utilized Minitab for comprehensive data analysis, validating fluorescence intensity, threshold cycle (Ct) values, Limit of Detection

(LoD) against established specifications, etc, to ensure highly sensitive and accurate diagnostic results across varying target concentrations.

● Developed automated scripts in Python to streamline data analysis and report generation from GeneXpert output files, improving data processing efficiency by 30% and reducing manual effort needed Product Transfer Associate Scientist October 2017 – February 2021

● Engaged in cross-functional collaboration with R&D, Project Planning, and Manufacturing to meet 100% of assay launch deadlines for Xpress Covid, Xpert MRSA, Xpert Breast Cancer Strat4, Xpress Flu/RSV, MTB Ultra and various other assays

● Using Good Laboratory Practice (GLP), utilized the proprietary company software (GeneXpert), ddPCR, and other basic molecular biology techniques to conduct Test Method Validations and Process Validations to qualify assays for production, with zero post launch failures or recalls

● Utilized Excel VBA macros to automate validation tasks for SPT worksheet updates, streamlining Document Change Order process.

● Received Make It Happen Award for contribution to timely closure of 17CAPA58

● Reviewed Batch Records/Device History Records for product builds executed on specialized assembly line ROBAL, verifying accurate documentation of essential information (lot numbers, component traceability, lot-to-lot compatibility, process parameters, etc)

● Coordinated product model builds for testing and validation purposes with Manufacturing and Material Handling teams, tracking the logistics of samples, reagents, cartridges, and other product components, ensured lot to lot compatibility, conducted necessary transactions via Enterprise Resource Planning (ERP) tool SAP, and minimized expenses for these test builds Thermo Fisher Scientific South San Francisco, CA

R&D Intern June 2016 – August 2016

● Involved in the development and optimization of a convenient and cost-effective protocol for purification of degenerate primers on SPE and HPLC, primarily utilizing Reverse Phase Fluoro-Pak and FluoroFlash technology for affinity based purification on column chromatography

● Utilized Agilent 1200 UPLC, SpectraMax 190 Microplate reader, and Agilent 6200 Series TOF-MS for sample testing and analysis in 96 well format at each step of purification process SKILLS

dd-PCR, RT-PCR, qPCR, SEC, SDS-PAGE, UV Vis, HPLC, RP (Reverse Phase), Mass Spectrometry, Gel Electrophoresis, Affinity Purification, GeneXpert, cGMP, GLP, GDP, Kaizen, Software Development, Python, Git, ChemCAD, Column Chromatography, Spectrophotometry, Continuous Process, Batch Process, Western Blotting, Pipetting, Reagent Preparation, Buffer Preparation, pH probes, Centrifuges, Minitab, Design of Experiments (DOE), Root Cause Analysis, Biosafety Level 2 (BSL-2), Lean Six Sigma, Agile, SAP, SQL

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