Simran Colvin
Brighton
Summary
Results-driven Research Analyst with proven success in immunogenicity assay development and validation. Skilled in data analysis and regulatory compliance, contributing to successful projects across multiple pharmaceutical clients .Proven leadership in cross-functional collaboration and data analysis across various platforms, coupled with strong troubleshooting skills. Adept in ELISA techniques, I thrive in fast-paced environments, driving innovative solutions, and ensuring strict compliance with regulatory standards.
Overview
4
4
years of professional experience
Work History
Research Analyst II
BioAgilytix
Boston
10.2023 - Current
- Independently led immunogenicity assay development and validation for biologic therapeutics across 20+ pharmaceutical clients, utilizing sterile cell culture techniques, including primary cell isolation, cryopreservation, and maintenance of multiple cell lines under aseptic conditions, while collaborating with senior scientists to optimize experimental strategies.
- Executed and troubleshot complex cell-based immunogenicity assays, including MSD electrochemiluminescence, ELISA, Quanterix Simoa ultra-sensitive immunoassay, and cell-dependent cytotoxicity assays, identifying root causes of assay failures and implementing corrective actions that restored performance within project timelines.
- Performed protein characterization and quantification using ELISA platforms, MSD technology, and Quanterix Simoa to analyze antibody-drug complex formation, measure anti-drug antibody responses in patient serum samples, and detect neutralizing antibodies across various drug modalities and development phases.
- Managed multiple concurrent validation projects under GLP regulations, maintained detailed laboratory notebooks, and documented comprehensive data to ensure regulatory compliance for client deliverables.
- Analyzed complex datasets from high-throughput sample testing workflows using WATSON LIMS, MySQL databases, Python, and R, performing statistical analysis to determine assay cut points, positivity thresholds, and quality control metrics, then compiling results into client-ready data tables and visualizations organized by sample dosage and time points.
- Developed automated data analysis pipelines using Python and R to streamline immunogenicity data processing and report generation, significantly reducing manual analysis time and enhancing reproducibility across multiple client projects.
- Conducted cross-functional collaboration with Analytical Chemistry, Quality Assurance, Project Management, and client teams to generate validation data, design experimental protocols, and ensure alignment between assay capabilities and client testing requirements across early-phase to late-phase drug development.
- Authored technical documentation, including method standard operating procedures, validation protocols, study reports, and assay transfer packages, communicating scientific findings and immunogenicity risk assessments to cross-functional stakeholders and regulatory audiences.
- Validated incoming data from method transfer projects, assuming technical leadership for validation execution, sample testing coordination, and troubleshooting of transferred assays to ensure successful technology transfer from originating laboratories.
- Performed thorough literature reviews and scientific research to support assay development strategies, identify best practices for immunogenicity detection methods, inform experimental design decisions, and complete method SOPs with scientifically sound rationale.
Research Analyst I
Sartorius Stedim Biotech
Cambridge
10.2022 - 09.2023
- Established and maintained adherent and suspension cell lines to support cell-based CDC assays.
- Proficient in designing, performing, and analyzing cellular in vitro assays to evaluate immune-mediated responses and functionalities.
- Conducted ELISA, CDC, and CD20 analyses on Softmax and Discover Workbench.
- Skilled in cell counting, viability assessments, and sample preparation for downstream assays.
- Contributed to, and provided input toward the development of assays.
- Set up equipment, organized inventory, and maintained lab areas.
- Assisted the team in meeting regulatory requirements by coordinating documentation and filings.
- Validated incoming data for accuracy and integrity, independently identifying and resolving discrepancies.
Research Associate
Akttyva Therapeutics
Mansfield
07.2022 - 10.2022
- Designed and conducted protein detection and purification assays including ELISA, Gel electrophoresis, and Western Blotting
- Performed quantitative real-time PCR experiments and DNA/RNA isolation techniques
- Conducted thorough research on protein binding and targets utilizing databases and physical records to inform experimental design
- Reviewed literature and integrated findings into ongoing projects to enhance research approaches
- Synthesized complex information into clear reports and spreadsheets to support decision-making
- Set up equipment, organized inventory, and maintained facilities
Education
Master of Science - Health Informatics
New England College
Henniker, NH12-2026
Bachelor of Science - Biology
University of Massachusetts, Boston
Boston, Massachusetts, MA05-2022
Skills
- Assay development
- Assay development and validation
- Immunogenicity assay design
- Cell culture techniques
- Cell and tissue culture
- Method development and sample analysis
- Data analysis
- Data validation
- Quanterix and MSD expertise
- ELISA techniques and methodologies
- ELN, LIMS, Watson, and Discover Workbench analysis
- Proficient with SQL, Python and R
- Project management
- Technical documentation
- Cross-functional collaboration
- Regulatory research
- Microsoft Office Suite
Custom Section 1
- Hypothesis of a Vaccine Development for a Viral Disease (Marburg Virus), Developed a hypothesis for the production of a possible vaccine for the Marburg Virus in order to understand disease control and drug development for viral pathogenesis. Created an experimental design, along with method development to tackle the disease in question, transmission and infection of the virus and managing the Marburg Virus epidemic. Role of the Shh Signalling Pathway in Planarian (Dugesia tigrina) Neoblasts, Investigated the role of the Shh signalling pathway in the functioning of neoblast cells in the species Dugesia tigrina. Formed a hypothesis by creating three different environments for the species to regrow in and analyzed how environmental stressors can affect the Shh signalling and the ability of the species to regrow.
Affiliations
Massachusetts Life Sciences Internship Challenge, 2022 : Participated in the Massachusetts Life Sciences Internship Challenge, which had over 50 life sciences and biotech companies look for their perfect intern, which is how I landed my internship at Akttyva Therapeutics
Timeline
Research Analyst II
BioAgilytix
10.2023 - Current
Research Analyst I
Sartorius Stedim Biotech
10.2022 - 09.2023
Research Associate
Akttyva Therapeutics
07.2022 - 10.2022
Master of Science - Health Informatics
New England College
Bachelor of Science - Biology
University of Massachusetts, Boston