Aishwarya Raghuvanshi

• Serve as the primary liaison between Amgen and Syngene (CRO), facilitating clear communication and collaboration.
• Reviewed over 250 Certificates of Analysis (CoA) per year and oversee quality control (QC) and quality assurance (QA) to ensure compliance with research and regulatory standards.
• Managed protein release processes of 250+ proteins per year, ensuring timely and accurate delivery to research teams at Amgen.
• Track and analyze errors, ongoing, and upcoming projects, maintaining meticulous records for operational efficiency.
• Blind confidential information prior to sharing project requests with the CRO, upholding data security and compliance.
• Conduct data analysis on operations metrics to assess and improve protein release timelines and project execution efficiency.
• Improved the protein release turn around time by 20% every year.
• Utilize information systems and tracking tools to enhance workflow and data-driven decision-making.
• Performed in-depth data analysis on operational metrics at discovery protein sciences US and Canada (Smartsheet) to improve protein release timelines, optimize workflow efficiency, and support informed decision-making through tracking tools and information systems integration

• Conducted patentability, validity, freedom-to-operate, and infringement searches to assess intellectual property risks and opportunities.
• Analyzed biotechnology industry trends to provide competitive intelligence and identify research and licensing prospects.
• Evaluated published patents and technical publications, ensuring alignment with regulatory and market trends.
• Delivered technical analysis and strategic insights on complex patent searches to support decision-making.
• Reviewed search results and generated detailed reports for internal stakeholders.
• Participated in special information projects, offering data-driven recommendations.
• Assisted project teams by providing technical, patent, and business intelligence to support research and innovation strategies.

Project: Indian Market and Pricing Analysis for Dupixent by Regeneron

• Developed a comprehensive project proposal and plan under the guidance of a mentor, outlining key objectives and deliverables
• Led end-to-end project management, including defining the project scope, creating a detailed Gantt chart, and establishing key milestones
• Effectively managed time and resources to ensure timely achievement of project goals
• Conducted in-depth research and market analysis to assess Indian consumer trends and preferences
• Formulated strategic insights on pricing trends, retail distribution channels, and estimated production and commercialization costs
• Performed PESTLE analysis, SWOT evaluation, and Porter's Five Forces assessment to develop competitive business strategies
• Presented research findings and strategic recommendations to a panel of industry experts

Project: Macro-nutrient Factors Influencing Maternal Health and Pre-term Birth in the NCR Region

Key Responsibilities

• Conducted routine Inductively Coupled Plasma Mass Spectrometry (ICP-MS) analysis to identify and quantify macro-nutrient factors.
• Led sample preparation for ICP-MS analysis to ensure accuracy and consistency.
• Optimized protocols for standardization and validation of macro-nutrient studies, with a focus on Silicon and Zinc.
• Performed Peripheral Blood Mononuclear Cell (PBMC) isolation, Flow Cytometry (FACS), and High-Performance Liquid Chromatography (HPLC) to enhance expertise and collaborate with research teams.
• Gained hands-on experience in troubleshooting and collaborated with technical experts to resolve analytical challenges.
• Conducted literature reviews of peer-reviewed research articles to support project findings.
  Authored and reviewed technical documentation, ensuring clarity and compliance with research standards.
• Collaborated with project coordinators and investors to refine research objectives and achieve key project milestones.
  

Clinical Trials & Flow Cytometry Specialist

• Led end-to-end management of 2 clinical trials, ensuring seamless execution and regulatory compliance.
• Collaborated with Contract Research Organizations (CROs) to optimize sample collection, logistics, and data reporting for sponsors.
• Conducted wet lab experiments across 10 clinical trials, contributing to data integrity and research outcomes.
• Skilled in sample preparation and immunological techniques, including Fluorescence In Situ Hybridization (FISH), cytogenetics, and ELISA.
• Worked in compliance with GxP guidelines and collaborated with the Quality Control team to uphold research standards.
• Optimized and validated clinical trial protocols in consultation with subject matter experts.
• Acquired, reviewed, and performed preliminary data analysis to support research findings.
• Authored and reviewed technical documentation, ensuring clarity and accuracy in research reports.
• Managed procurement by coordinating with vendors and suppliers for laboratory needs.
• Contributed to oncology diagnostics by working with the Flow Cytometry team on serum and tissue sample analysis.