Summary
Overview
Work History
Education
Skills
Timeline
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PARTH SHAH

Watertown,MA

Summary

Dynamic and results-oriented professional with extensive experience in the industry, adept at assay development and showcasing exceptional scientific writing skills. Spearheaded innovative analytical methods, achieving significant process optimizations. Demonstrated leadership in project design, enhancing throughput by 20%, and excelling in protein characterization and strategic problem-solving.

Overview

4
4
years of professional experience

Work History

ASSOCIATE SCIENTIST, ANALYTICAL DEV.

VISTERRA INC.
Waltham, MA
03.2023 - Current
  • Conducted comprehensive charge variant characterization studies using traditional WCX-HPLC, and developed a novel cIEF-MS method on the lead candidate in preparation for the Biologic Licensing Application (BLA), ensuring regulatory compliance and facilitating successful product approval.
  • Designed and implemented a robust RP-HPLC method specifically tailored for the precise quantitation of disulfide isoforms in IgG2 antibodies, contributing pivotal analytical insights, crucial for product development and regulatory submission.
  • Conducted forced degradation analysis to elucidate primary degradation pathways for monoclonal antibodies, facilitating targeted mitigation strategies, and ensuring product stability.
  • Worked extensively on executing developability studies for screening early-stage modalities.

SCIENTIST, FORMULATION DEV.

LEUKOCARE INC.
Milford, MA
06.2022 - 02.2023
  • Proficiently translated project designs into streamlined operational plans and workflows
  • Skillfully synthesized extensive investigation results into concise presentations for the executive board, resulting in actionable insights and a notable 28% reduction in decision timelines
  • Independently integrated new technologies in alignment with strategic goals, while playing a pivotal role in knowledge transfer, client relations management, and infrastructural development, demonstrating strong accountability and ownership towards project objectives

ASSOCIATE SCIENTIST, FORMULATION DEV.

LEUKOCARE INC.
Milford, MA
10.2021 - 06.2022
  • Pivotal first hire at the Milford site, contributing significantly as a valued team member
  • Spearheaded initiatives to enhance experiment design processes and forge strategic partnerships, resulting in a notable 20% increase in throughput
  • Demonstrated exceptional autonomy in executing customer project activities within designated timelines and budgets, while also independently spearheading instrument qualifications and implementing new technologies, all within a dynamic work environment, showcasing strong communication and organizational prowess
  • Additionally, managed lab notes for data evaluation and conducted regular data integrity checks to ensure accuracy and reliability

RESEARCH SCIENTIST (COOP)

STEVANATO GROUP
Boston, MA
01.2021 - 08.2021
  • Strategically planned and scheduled qualification and verification documentation for newly installed instruments within a rigorously compliant cGMP and DEA guidelines environment
  • Implemented structured validation methodologies to conduct test protocols for fill/finish and container-closure testing systems, resulting in a notable 25% process optimization
  • Oversaw precise inventory management and maintained rigorous lab notebook procedures, exceeding accuracy targets by 10%
  • Proficiently managed sophisticated instruments, swiftly troubleshooting issues to decrease downtime by 8%

Education

Master of Science - Project Management (Biotechnology)

Harrisburg University
Harrisburg, PA
08-2026

Master of Science - PHARMACEUTICAL SCIENCES

Northeastern University
Boston, MA
09.2021

Bachelor of Science - Pharmacy

CHARUSAT University
India
05.2019

Skills

  • Assay development
  • Scientific writing
  • Standard operating procedure development
  • Protein characterization
  • Spectroscopy methods
  • Particle size analysis

Timeline

ASSOCIATE SCIENTIST, ANALYTICAL DEV.

VISTERRA INC.
03.2023 - Current

SCIENTIST, FORMULATION DEV.

LEUKOCARE INC.
06.2022 - 02.2023

ASSOCIATE SCIENTIST, FORMULATION DEV.

LEUKOCARE INC.
10.2021 - 06.2022

RESEARCH SCIENTIST (COOP)

STEVANATO GROUP
01.2021 - 08.2021

Master of Science - Project Management (Biotechnology)

Harrisburg University

Master of Science - PHARMACEUTICAL SCIENCES

Northeastern University

Bachelor of Science - Pharmacy

CHARUSAT University
PARTH SHAH