Neerali Shah
Summary
Experienced Scientist with a strong background in drug development, method validation, and analytical techniques. Proven track record in managing lab operations, optimizing bioprocesses, and ensuring compliance with regulatory standards. Adept at leading continuous improvement projects, conducting thorough data reviews, and providing technical support. Excellent communicator with experience in client interfacing and cross-functional team collaboration
Overview
17
17
years of professional experience
Work History
Scientist, Study Coordinator
Worldwide Clinical Trials
10.2022 - Current
- Perform QC review of data using scientific judgment regarding the quality and integrity of data and records associated with assigned studies
- Ensured that all analytical, operational and performance procedures were conducted in accordance with applicable Standard Operating Procedures (SOPs), Good Laboratory Practices (GLP), study plans, and protocols
- Contributed to the writing, preparation, and review of Sample Analysis Plans, Validation Plans, Analytical Test Methods, study reports, SOPs, and protocols with adherence to GxP, ICH and FDA regulatory guidelines
- Proficiently utilized Watson LIMS for data import, processing, and review of run results, as well as maintaining run trackers and other relevant tasks in MS Excel
- Ensure quality of deliverables including data, reports, and electronic files
- Draft written procedures and templates to maintain a standardized quality output
- Played a key role in ensuring the quality of deliverables, including data, reports, and electronic files
- Continuous Improvements Project Lead - Achieved cost savings of over 60% via resource optimization
- Assisted the Bioanalytical Study Manager to act as the primary point of contact for clients, ensuring effective client interface and satisfaction
- Scheduled and coordinated analyst work and instrument time, optimizing resource allocation and meeting project deadlines
- Simultaneously managed several complex projects, meeting all pertinent milestones.
Associate Scientist
Molecular Templates
11.2021 - 05.2022
- Managed and optimized cell-line growth processes for drug production, ensuring high yield and quality using BioFlo 120 and DASGIP bioreactors
- Developed and implemented protocols for upstream drug development, significantly improving efficiency and scalability
- Contributed to downstream drug production processes like preparation of buffers, column packing, microfluidization techniques, UV spectrometry analysis, protein analysis via SDS-gels and western blotting
- Worked closely with cross-functional teams to integrate upstream processes with downstream purification and production stages
- Mentored junior scientists, providing guidance on experimental design and data analysis.
Senior Manufacturing Associate
Molecular Templates
05.2021 - 09.2022
- Executed downstream GMP manufacturing operations by performing protein purification using chromatography techniques to isolate target protein from impurities
- Partnered with Quality Assurance personnel to deliver a quality product following Standard Operating procedure (SOP) guidelines and ALCOA principles
- Provided troubleshooting, technical support, and effective resolution of equipment and process issues on the manufacturing floor, ensuring minimal disruptions to production
- Conducted comprehensive training sessions for manufacturing staff on process optimization and equipment usage
- Reviewed executed cGMP documentation (Batch Records, forms), to ensure compliance and accuracy
- Oversaw deviation investigations and conducted root cause analysis to maintain process integrity and ensure compliance
- Implemented and lead the 6S system organization and created a Kanban inventory system for the department
- Demonstrated versatility adaptability taking different roles responsibilities assigned including machine operator, quality inspector, or material handler.
Lab Manager and Editorial Assistant
University of Texas at Austin
06.2016 - 05.2021
- Editorial Assistant for Drug Development and Industrial Pharmacy
- Managed lab day to day activities (ordering, safety, compliance, meetings, scheduling, technical assistance)
- Contributed in preparation of scientific writing including grants, scientific manuscripts
- Coordinated lab schedules, tracked milestones, and managed project deliverables to ensure timely completion of research goals
Research Associate, Analytical and Pharmaceutical Sciences
Immunogen Inc.
12.2007 - 06.2009
- Supported late-stage development of drug products, ensuring successful progression through critical phases
- Developed analytical methods using HPLC systems for the identification of drug products, contributing to accurate and reliable results
- Maintained stability protocols for drug products, ensuring consistency and compliance with concentration change guidelines
- Performed SDS-PAGE analysis on drug products, providing detailed protein characterization
- Attended conferences and workshops to stay updated with the latest industry trends and technologies
- Prepared posters and presentations, summarizing stability data for scientific dissemination
Education
Master of Science - Pharmaceutical Sciences
Northeastern University
Boston, MA08-2007
Skills
- Analytical techniques
- Method Development
- Quality Control
- Project Management
- Client Interaction
- Regulatory Compliance
- Data Management
- Training and Development
- Adaptability and Flexibility
Publications
- Forced Degradation Studies of DM1: The Maytansinoid Component of Some Novel Antibody-Maytansinoid Conjugates, Shah Neerali, 2009, ImmunoGen Inc.
- In vitro inhibitory potential of protease inhibitors on UGT1A1 catalyzed bilirubin glucuronidation, Shah Neerali, Chavan Ajit, Paradice Arthur, Jayaraj Andrew, 2007, Vertex Pharmaceuticals Inc.
- Drug Delivery Systems, Shah Neerali, 2003, Indian Pharmaceutical Association
- Micro-encapsulation, Shah Neerali, 2002, Annual research day, MET
Languages
Hindi
Native or Bilingual
Telugu
Full Professional
Gujarati
Native or Bilingual
Marathi
Full Professional
Timeline
Scientist, Study Coordinator
Worldwide Clinical Trials
10.2022 - Current
Associate Scientist
Molecular Templates
11.2021 - 05.2022
Senior Manufacturing Associate
Molecular Templates
05.2021 - 09.2022
Lab Manager and Editorial Assistant
University of Texas at Austin
06.2016 - 05.2021
Research Associate, Analytical and Pharmaceutical Sciences
Immunogen Inc.
12.2007 - 06.2009
Master of Science - Pharmaceutical Sciences
Northeastern University
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