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Director Of Scientific Operations Manufa...
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Title Director of Scientific Operations & Manufacturing
Target Location US-FL-Gainesville
Email Available with paid plan
Phone Available with paid plan
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Candidate's Name , Ph.D., Gainesville, FL 32608Scan to see my LinkedInPHONE NUMBER AVAILABLE EMAIL AVAILABLE LINKEDIN LINK AVAILABLE US Permanent Resident PROFESSIONAL SUMMARYA seasoned scientific operations leader with high functional competency, driving organizational success through expertise in managing pre-clinical research, drug discovery, manufacturing, biologics, and clinical trials. Extensive expertise in strategic planning and team management, motivating multidisciplinary teams and reducing cost and speed up projects ensuring adherence to timelines and quality standards. Proven ability in using diagnostic tools, optimizing operational efficiency through successful project outcomes to advance scientific discoveries and delivered impactful results.Excellent science communicator, published 4 books/book chapters and more than 100 research articles in high impact journals and scientific magazines.PROFESSIONAL EXPERIENCEDirector of Scientific Operations & Manufacturing (Dual role: Commercial /Scientific) Oct 2019- May 2024 Betterhumans Inc, Gainesville, FL Demonstrated excellence in driving customer-focused solutions, leveraging deep knowledge in NGS and PCR applications to spearhead the development and execution of groundbreaking products. Extensive hands-on experience in next-generation sequencing, PCR, and molecular profiling, underpinning comprehensive product development abilities and innovative application strategies. In-depth expertise in contrasting nucleic acid purification platforms, including QIAcube Connect EZ1 and Promega Maxwell RSC Instruments, providing critical quantitative and qualitative feedback to inform product development and integrate customer insights into the innovation process. Expertise in instruments like the Maxwell RSC Instrument (RUO mode) alongside its improved version, the Maxwell CSC Instrument for IVD and research use (IVDR), delivering critical feedback to enhance product performance for both diagnostic and research applications. Spearheaded beta testing of GMP and cGMP grade equipment and assay kits from multiple vendors, providing critical insights and ensuring high-quality standards for successful commercial product introductions. Executed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for over 15 equipment in strict adherence to regulatory standards, highlighting proficiency in ensuring compliance and operational excellence.(QuantStudio Pro, NGS, Ion torrent, Gene studio S5 Sequencer and Illumina iScan, Biospherinx glovebox, Protein Simples JESS and Ella, Repligens TFF, Quanterixs Simoa, Millipores SMCxPRO, RayBiotech-Innopsys, Luminex Bio-Plex, CytoFLEX,). Designed and established three advanced tissue culture laboratories, showcasing exceptional skills in laboratory setup, equipment acquisition, and process optimization while maintaining the highest levels of safety and quality standards. Implemented Corrective and Preventative actions (CAPAs) through meticulous documentation of experimental adjustments and diligent monitoring of unforeseen issues, demonstrating a strong commitment to troubleshooting, problem-solving, and quality assurance. Overseen scientific and financial operations, providing leadership in contract negotiations, purchase order management, and invoicing procedures since 2019, ensuring financial practices are conducted efficiently and in compliance with regulatory standards. Led and oversaw the successful introduction of a state-of-the-art cleanroom facility tailored for biologics, providing essential support for cell and gene therapy production. Achieved significant cost and time savings by expertly optimizing manufacturing processes, budgeting, cost analysis, and resource allocation, thereby enhancing profitability. Fostered a positive team environment that encouraged professional growth, inclusivity, and a collaborative culture, resulting in enhanced employee development and increased productivity. Played a pivotal role in driving business success and maximizing profitability through strategic recruitment, identifying and nurturing top talent that contributed significantly to organizational growth and achievement. Provided strategic leadership, ensuring high standards of integrity, safety, and compliance, leading to successful trial outcomes. Technical accomplishments: Executed 4-diverse single molecule array platforms for efficient and accurate inflammatory biomarkers and cytokine profiling in human samples, thereby enhancing data acquisition quality. Led pilot studies assessing the safety and efficacy of targeted drugs, improving biomarkers for metabolic disorders, inflammation, and DNA damage repair, offering valuable insights for future therapeutic istrategies. Leveraged cutting-edge automated technology to bridge the gap between laboratory research and clinical applications, enabling the translation of cutting-edge scientific discoveries into tangible advancements for patient care. Managed 11 complex projects concurrently, maintaining adherence to all milestones and exhibiting outstanding organizational, multitasking skills, and the ability to meet tight deadlines. Utilized data from a safety study to administer umbilical cord plasma concentrates injections in elderly subjects, determining biological age through comprehensive analysis of DNA methylation, telomerase length, and mitochondrial copy number with findings recently published in a prestigious journal Aging Cell. CORE COMPETENCIES Successfully drove revenue growth, optimized resource allocation, and coordinated strategic plans, resulting in measurable business expansion and improved financial performance. Provided institutional oversight and effectively managed shared resources and space utilization, ensuring efficient utilization of assets and promoting cost savings. Oversaw reporting, decision-making, and regulatory responses, while strategically planning and implementing initiatives to drive operational excellence and compliance. Ensured consistent protocol reproducibility within defined budgetary constraints, optimizing study outcomes while maintaining fiscal responsibility. Developed and implemented policies, procedures, and plans to enhance and guide company activities, fostering operational efficiency and alignment with organizational objectives. Excelled in program management and exhibited exceptional team leadership abilities throughout a 17-year career in academia and industry, driving successful project outcomes and fostering high-performing teams. Skillfully managed partnerships and strategic business relationships, effectively negotiating contract terms and adeptly handling conflicts, resulting in mutually beneficial collaborations and business growth. Conducted comprehensive document reviews and ensured quality control of data acquisition, enabling the derivation of meaningful conclusions and providing critical insights to support decision-making processes. Cultivated courteous and effective working relationships with cross-functional teams both internally and externally, fostering collaboration and achieving collective goals.Principal Investigator: Department of Bioengineering Feb 2016  Oct 2018 University of Illinois at Chicago, Chicago, IL.Manager and Research Scientist: Department of Biology Dec 2014  Jan 2016 University of Arkansas at Little Rock, AR.Lab Manager: Center for Neuroscience Research Oct 2013  Nov 2014 Childrens National Medical Center, Washington, DC. Post-Doctoral Associate: Department of Anesthesiology Jun 2011  Sep 2013 College of Medicine, University of Florida, Gainesville, FL. EDUCATION Ph.D (Microbiology/Biotechnology- Neuroscience) From Indian Institute of Technology (IIT), India MS (Microbiology) BS (Biological Sciences)For a list of publications and citation indices click here https://scholar.google.com/citations?user=0uBYDCcAAAAJ INTERESTSPhotography, music and a travel enthusiast: enjoy discovering new places.

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