Khushi Patel

Experience

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  Bio Re Inventors Lab

  Jun 2021 - Jul 2021

  Online Internship

  Learned Computer Aided Drug design (20th June- 18th July).Learned docking and how to run AUTODOCK and PyMOL software.Learning outcomes from this course:•Understanding various sources of drug discovery•Knowing how drugs work at the molecular level •Understanding how different receptors interact with drugs• Became familiar with cutting-edge drug design techniques such as computer based QSAR and molecular graphics

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  SUN PHARMA

  Jun 2021 - Jun 2021

  Regulatory Intern

  •Assisted in regulatory and medical writing of pharmaceutical products in eCTD format per FDA submission guidelines.•Drafted ANDA applications, SOPs, product labeling, and conducted literature reviews to ensure accurate regulatory documentation.•Monitored and upheld quality standards of therapeutic products per ICH, QbD, cGMP, and GxP guidelines.•Collaborated with cross-functional teams, including analytical chemistry, regulatory affairs, and quality control, to support product development, ensure cGMP adherence and troubleshoot compliance issues.•Reviewed batch manufacturing records (BMRs). Show less

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  BioVQR Healthcare Pvt. Ltd.

  Dec 2022 - May 2023

  •Conducted ICSR case processing supporting pharmacovigilance, and signal detection.•Led regulatory documentation, and medical writing for drug submissions, ensuring adherence to GDP, QbD, and international regulatory guidelines.•Demonstrated strong organizational, time management, and teamwork skills, effectively managing projects, streamlining workflows, and ensuring timely regulatory reporting.•Collaborated with cross-functional teams in medical affairs, R&D, and regulatory compliance, optimizing drug safety monitoring, clinical module writing, and market research. Show less

  • Business Development Executive

    Mar 2023 - May 2023

  • Trainee Officer- Drug Discovery and Medical Affairs

    Dec 2022 - Feb 2023
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  Northeastern University

  Jan 2024 - now

  • Supervise the onboarding of new volunteers by delivering mandatory lab training and ensuring adherence to safety and procedural standards• Designing website for the lab • Studied the effects of TNF-alpha and IL-6 on STAT3 signaling by quantitation of Secreted Alkaline Phosphatase (SEAP) assay in HEK Blue/IL-6 cells• Performed transfections on the BOSCH 23 cells using alpha-7 and 5HT3 Chimera to check expression of alpha 7 receptor• Analyzed the impact of RIC3 and TMEM35 (NACHO) on the expression of alpha 7 receptor• Led basic laboratory operations, pipetting, binding assays, radiation safety, PCR, DNA extraction, genotyping, and result analysis

  • Team Supervisor

    Jan 2025 - now

  • Graduate Research Assistant at Dr. Ralph Loring's Lab

    Jan 2024 - now
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  Vertex Pharmaceuticals

  Jul 2024 - Dec 2024

  CGT- Hematopoietic Stem Cell Research Co-op

  • Executed over 20 TIDE sequencing analysis, encompassing DNA/RNA extraction, PCR troubleshooting, and purification to assess editing efficiency of conjugated lipid nanoparticles (LNPs) to deliver gene-editing mRNA • Conducted daily aseptic mammalian cell culture tasks, including electroporation and cryopreservation for cell banking• Optimized the DNA extraction protocol of Zymogen kit to achieve higher gDNA concentration with improved quality• Conducted in-vitro differentiation study of CD34+ HSCs by dosing tool siRNA and ADC to induce fetal hemoglobin expression and quantified using flow cytometry, RNA extraction and ddPCR• Assisted in bone marrow harvesting from rodent femur and tibia, isolating CD34+ cells through MACS separation and analyzed by flow cytometry• Performed MiSeq next-generation sequencing (NGS) processes, including library preparation and sample loading• Collaborated with the non-viral delivery team to prepare & characterize LNPs for mRNA delivery and quantify using ELISA, MSD Assay, and Western Blotting.• Prepared Virus Like Particles (VLPs) by performing transduction with lentiviral vector. Show less