Prachi Shah Email & Phone Number

Cambridge, Massachusetts, United States

United States

Cambridge, Massachusetts, United States

• Manage global CxOs for Quality Control for late stage and commercial gene therapy products
• Design and oversee validation and remediation of QC methods used for in-process, release, and stability testing
• Author and review method lifecycle documents such as protocols, reports, Test Methods, SOPs
• Analyze data generated at external CxOs during method lifecycle activities using statistical software
• Support cGMP routine testing by owning/following quality systems required for… Show more
• Support cGMP routine testing by owning/following quality systems required for deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results

Cambridge, Massachusetts, United States

• Conducted LC/MS analysis of compounds from various biological matrices to establish the metabolism of the parent compound and quantify its subsequent metabolites
• Developed various microbiome-based assays and troubleshooting to support the assay development team
• Developed methods for high-throughput LC/MS assays by optimizing MRM for compounds and LC parameters by Discovery Quant (analyst software)
• Designed experiments and report data in written reports and team… Show more
• Designed experiments and report data in written reports and team presentations.
• Analyzed, processed, and reported data to the team to support the research project. Show less

Cambridge, Massachusetts, United States

Greater Boston Area

Greater Boston Area

• Proficient in method development/ method transfer, method validation and sample analysis for GLP and non-GLP studies
• Performing LC/MS/MS method development of analytes by tuning in positive and negative ion modes with MS/MS parameter optimization; Optimization of LC parameters including column and mobile phase selection, isocratic.
• Sample preparation by Liquid-liquid… Show more
• Sample preparation by Liquid-liquid Extraction, Solid Phase Extraction, and Protein precipitation
• Developing method to assess microsomal stability for new molecular entities using liver microsomes from different species
• Regularly performed preventative maintenance on the LC/MS

Greater Boston Area

• Analyzed biological samples of plasma, serum or tissues by sample preparation, concentration data processing and reporting using Analyst software to support pharmacokinetic profiling of small molecules
• Performed LC-MS/MS method development projects by tuning and compound optimization
• Processed and reported data using analyst software to support TK and PK profiling of small molecules
• Responsible for reviewing data, generating reports and recording process after each… Show more
• Responsible for reviewing data, generating reports and recording process after each experiment Show less

Greater Boston Area

• Maintained mammalian cell culture for adherence cell lines (HS5, MCF 7 sensitive, HeLa), prepared media and provided specific concentration of cells
• Involved in performing microfluidic bioassays on Lab-on-a-Chip (LOC) devices to monitor single cell analysis and cell-cell interaction

Lexington, Massachusetts

• Gained in-depth knowledge of clinical trial databases by working with Trial Masters File (TMF), Clinical Trial Management System (CTMS), Audit tracking and SharePoint
• Learned strategy behind decision making process in clinical trials by attending clinical trial team meetings and providing detailed meeting minutes to the group
• Designed a poster presentation on “Benefits and Challenges of electronic Clinical Outcome Assessments” focusing on elimination of paperwork by using hand-held… Show more
• Designed a poster presentation on “Benefits and Challenges of electronic Clinical Outcome Assessments” focusing on elimination of paperwork by using hand-held electronic devices for better clinical assessment Show less

Greater Boston Area

• Managed e-coli and mammalian cell (suspension- CHO cell line) based projects in collaboration with other lab assistants
• Developed SOPs of Nova Stat Prime Glucose-Lactate Analyzer and YSI 2900 Biochemistry Analyzer.
• Assisted in performing bench scale bioreactor for microbial as well as mammalian cell culture to learn bioprocess engineering concepts of cell growth and product kinetics
• Performed HPLC and ELISA to quantitate IgG1 obtained from CHO cell culture
• Aided graduate… Show more
• Aided graduate students in performing and troubleshooting microbial and cell culture based experiments

Vadodara Area, India

• Counselled patients regarding physical symptoms, drug dosage, frequency and mitigation of side effects
• Accurately delivered medicine to patients per prescription instructions with compassion
• Monitored medicine inventory, and maintained sufficient supply of medicines and surgical products

Professional Masters Of Science (Psm), Biotechnology, Gpa 3.7

Pg Diploma In Clinical Pharmacy, Post B.Pharm Professional Course In Clinical Pharmacy, Gpa 3.80

Bachelor Of Pharmacy (B.Pharm), Pharmaceuticals, Gpa 3.89