Manik Kuvalekar
Cypress,TX
Summary
Research Associate(BCM) and Research scientist I with Allovir (past) ) with 10+ years of experience in T-cell therapy development, GMP-compliant manufacturing, and clinical trial. Proven track record of bridging preclinical research with clinical execution — translating 5+ studies into patient-administered clinical trials. Deep expertise in VST/CAR-T/T cell therapy, process development, cross-functional leadership, and regulatory compliance (FDA GLP/GMP/GTP, FACT, CAP, CLIA). Adept at mentoring junior team members and scientists and driving operational excellence in ISO-classified environments.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Research Associate
Baylor College Of Medicine
Houston, TX
01.2022 - Current
- Expertise in patient logistics and scheduling to ensure strict adherence to care timelines for clinical trials targeting solid tumors, lymphomas and leukemia
- Ensured rigorous adherence to FDA regulations and FACT/CAP/CLIA standards by overseeing all technical procedures and quality documentation
- Coordinated cross-functional teams to assemble and verify critical release testing documentation for original IND submissions and protocol amendments
- SME in automated cell processing with a proven track record of optimizing VST/Tcell/CAR-T manufacturing. Specialized in utilizing G-Rex technology to enhance the metabolic fitness and viability ad reduce production time of VSTs, tumor specific T cells, CAR-Ts. Expert in leveraging LOVO, CliniMACS Prodigy, and Gatherex platforms to streamline production
- Oversaw cross-functional teams to execute equipment validation cycles, ensuring all documentation met strict FDA audit requirements
- Accelerated the translation of 5+ preclinical studies into clinical trials by establishing standardized SOPs and rigorous validation protocols, directly enhancing patient safety and trial efficacy
- Led the technical scale-up and optimization of the Viralym-M (ALVR105) platform, ensuring clinical readiness for early-late-stage global trials
- Consulted for commercial partners to streamline the transportation Documents deviations and non-conformance events, ensuring prompt notification to Principal Investigators and Quality Management
- Facilitated high-volume infusion therapy for a diverse patient population while managing all associated clinical paperwork
- Supervised department-wide clinical documentation processes to ensure full compliance with healthcare regulations and facility policies
- Audited patient charts and documentation for accuracy, providing guidance to clinical staff to improve record-keeping standards
- Prepared materials for reports, presentations and submission to peer-reviewed journal publications
- Identified and resolved technical deviations in coordination with Quality Assurance, maintaining uninterrupted laboratory service and high-quality patient data
- Monitored equipment performance and reagent integrity through rigorous QC checks, facilitating seamless integration between bench work and quality oversight
- Authored clinical(IND) reports to support patient administration and cell therapy product development
- Executed end-to-end production for clinical pipelines, including tumor specific protocols (ID NCT01333046 ID NCT02291848 ID NCT02239861ID NCT02494167 ID NCT03192462) ensuring 100% compliance with sterile processing standards
- Expertly executed aseptic processing of blood-derived products within ISO 7 environments, ensuring zero deviations in sterility and product integrity
- Maintained meticulous paperwork for over 100 patient infusion procedures, complying with HIPAA regulations and facility auditing standards
- Screened, profiled and analyses healthy donors to establish a high-quality data foundation for HLA-specific analysis Cytomatch™ algorithm, a proprietary component of their off-the-shelf virus-specific T-cell (VST) therapy platform
- Managed and mentored a multi-disciplinary team of 8+ by cultivating a high-performance culture by providing continuous technical oversight and professional development to a diverse group of clinical and academic researchers
- Directed the development and characterization of critical potency assays for MT-601 multi-TAA-specific T cell therapies (MARKER Therapeutics)
- Managed cross-functional workflows to ensure assay robustness for FDA submission and future commercialization(MARKER Therapeutics)
Research Scientist-I
AlloVir
Houston, TX
07.2018 - 12.2023
- Led donor profiling and analyzing which involved large-scale data collection from healthy donors to build a diverse bank of partially HLA-matched VSTs donors to establish high-quality data foundation for HLA-specific analysis Cytomatch™ algorithm, a proprietary critical component of ALLOVIR Virus-Specific T-cell (VST) therapy platform
- Executed end-to-end production for clinical pipelines including lead assets CHARMS (NCT02108522), ARMS (NCT01570283), ALVR-106(NCT04933968), BATIT (NCT04401410)
- Conducted complex immune reconstitution studies to support the Phase 2 trial of Posoleucel, focusing on preventing clinically significant viral infections in HCT patients
- Managed large-scale data for T cell receptor (TCR) tracking and IFN-ELISpot analysis to monitor donor-derived T cell expansion and immune assessment in a randomized, double-blind Phase 2 clinical trial.multicenter trial (NCT04605484)
- Bridged the gap between R&D and manufacturing by partnering with CMC Operations to execute seamless technology transfers and process validations.
- Maintained rigorous compliance within Quality Management Systems (QMS), including Ideagen, BlueCord, and Veeva Vault
Senior Research Assistant
Baylor College Of Medicine
Houston, TX
07.2019 - 12.2021
- Immunoassays: Executed high-throughput assays including IFN-gamma ELISpot, ELISA, and Luminex (Milliplex & R&D Systems) to evaluate cytokine profiles
- Cellular Assays: Conducted functional immune assays, including Chromium (Cr) release, Intracellular Cytokine Staining (ICS), and Activation-Induced Marker (AIM) assays
- Cytometry & Separation: Performed multi-color flow cytometry and automated cell isolation using MACS magnetic selection/depletion techniques
- Molecular Biology: Streamlined DNA and RNA extraction workflows using specialized kits, including DNeasy Blood & Tissue and PureLink Total RNA Blood kits
- Isolated high-purity PBMCs from leukapheresis products using density gradient centrifugation and automated separation techniques
- Generated antigen-specific Dendritic Cells (DCs) and T cell blasts using OKT3/PHA activation protocols for downstream immunotherapy applications
- Executed complex primary cell culture techniques, including the differentiation of DCs and the generation of PHA/OKT3 blasts for functional assays
- Identified areas where existing processes could be optimized, resulting in increased productivity
- Developed innovative approaches to problem solving that led to improved efficiency in project execution
- Assisted in developing protocols for conducting experiments according to ethical standards
Research Technician III
Baylor College Of Medicine
Houston, TX
07.2014 - 06.2019
- Maintained accurate records of all experiments conducted with meticulous attention to detail
- Developed protocols for new procedures and optimized existing ones to improve efficiency
- Managed inventory levels of reagents and supplies needed for daily operations
- Trained junior staff members on proper laboratory techniques and safety regulations
- Cleaned, maintained and prepared supplies and work areas
- Compiled laboratory test data to perform appropriate analyses
- Worked closely with principal investigator on designing study plans
Teaching Assistant
Baylor College Of Medicine
Houston, TX
08.2013 - 05.2014
- Trained students in Protein Quantification, Gel Filtration Columnchromatography, Plasmid isolation, PCR
- Assisted faculty in developing and implementing course materials for diverse student needs.
- Facilitated communication between students and professors to enhance academic support.
- Organized and led study sessions, fostering collaborative learning environments.
- Evaluated student performance, providing constructive feedback to improve outcomes.
Research Intern
Baylor College Of Medicine
Houston, TX
08.2013 - 12.2013
- Conducted transgenic mice expression analysis by isolation of RNAfrom mice tissue by trizol & RNA easy prep, RNA Quantification &concentration, cDNA synthesis & quantification, mouse genotyping
- Worked on cloning of ERR alpha & HIF alpha, Maxi prep & Mini prep methods,Ligation,bacterial transformation, Restriction Digestion analysis
- Performed gene expression analysis of PGC-1alpha, PGC-1beta &Coup-2 using qPCR Exposure to soleus & TA muscle dissection of mice,immunohistochemistry and manipulation of cell culture
Education
Master of Science - Cellular And Molecular Biology
University of Houston, Clear Lake
Houston05-2014
Skills
- Cancer Immunotherapy
- GMP
- Cross functional collaboration
- Project Management
- Consulting
- Lab operations
Certification
- GMP (FDA regulations) Baylor College of Medicine, July 2015
- Introduction to Principles and Practice of Clinical Research Training - June 2017
- Good Clinical Practice (U.S. FDA focus), CITI Program, March 2025-2028
- Research Conflict of Interest Course, CITI Program, Cotober 2025-2029
- Biomedical Research - Basic/Refresher, CITI Program, March 2025-2028
Citations
https://scholar.google.com/citations?user=6ABA1lsAAAAJ&hl=en
Languages
English
Full Professional
Hindi
Native or Bilingual
Timeline
Research Associate
Baylor College Of Medicine
01.2022 - Current
Senior Research Assistant
Baylor College Of Medicine
07.2019 - 12.2021
Research Scientist-I
AlloVir
07.2018 - 12.2023
Research Technician III
Baylor College Of Medicine
07.2014 - 06.2019
Teaching Assistant
Baylor College Of Medicine
08.2013 - 05.2014
Research Intern
Baylor College Of Medicine
08.2013 - 12.2013
Master of Science - Cellular And Molecular Biology
University of Houston, Clear Lake