Summary
Overview
Work History
Education
Skills
Websites
Intellectual Property Rights
Publications
Languages
References
Timeline
Generic
Saikat Chakraborty

Saikat Chakraborty

Indianapolis,IN

Summary

Seasoned Assistant Director offers advanced knowledge of business operations and 6 years of progressive experience. Verifiable background overseeing business plans, operations and managing teams. Polished in navigating deadlines to keep staff on schedule.

Overview

12
12
years of professional experience

Work History

Associate Director, Analytical Development Lead

Genezen
Indianapolis, IN
01.2023 - Current
  • Generate ideas to develop new analytical testing for LVV potency assay and residual testing
  • Technology evaluation for Lenti and AAV platforms
  • Provide strategic leadership in analytical development for nucleic acids, viral vectors, and cGMP production
  • Develop and deploy biological and molecular assays (ddPCR, qRTPCR, ELISA, cell-based and ddPCR based viral vector potency assay) for gene therapy product characterization
  • Assay development and Technology transfer to Mentor and motivate team members to achieve corporate objectives in a startup setting
  • Collaborate in client-facing roles and strategic decision-making with upper management.

Senior Scientist, Analytical Development

Genezen
Indianapolis, IN
07.2020 - 12.2022
  • Developed and qualified ddPCR, qPCR, ELISA, and flow-based assays for lentiviral vectors
  • Led troubleshooting efforts in LVV analytical assay development with a team of scientists and associates
  • Evaluated novel analytical testing methods/tools for suitability in viral vector potency and residual testing.

Quality Control - Biochemistry | Viral Vector Specialist

Novartis Gene Therapy
Libertyville, IL
06.2019 - 07.2020
  • Developed and validated ddPCR assays for genomic titer determination in ZOLGENSMA and other gene therapy products
  • Ensured adherence to GDP and GLP standards while demonstrating strong technical writing skills for SOPs and method validation protocols
  • Gained valuable experience in a GMP environment.

Senior Researcher | Gene Therapy and Preclinical Neuroscience

Feinberg School of Medicine - Northwestern University
Chicago, IL
06.2016 - 05.2019
  • Led in vivo experiments in cognitive neuroscience, optimized viral vector (AAV9, CRISPR) approaches, and conducted pharmacodynamics studies in Alzheimer's disease
  • Established CRISPR-Cas9 based gene knockout systems, AAV9 overexpression systems, and conducted electrophysiology studies
  • Supervised biochemical/molecular analysis, performed mouse brain surgeries, and contributed to grants, protocols, and scientific reports.

Postdoctoral Research Associate | Neuropharmacology and Pain Research

Stony Brook Medicine
Stony Brook, NY
06.2013 - 05.2016
  • Led preclinical pain model development, executed in vitro neuropharmacology research, and managed lentiviral RNAi studies
  • Contributed to novel oncology model development with A549 lung cancer cell line.

Postdoctoral Researcher | GI Smooth Muscle Cells

Harvard Medical School
Boston, MA
04.2012 - 05.2013
  • Optimized chloride channel studies, conducted protein expression analysis, and initiated in vivo pharmacology research
  • Confocal microscopy of tissues and cells.

Education

PhD in Molecular Biology -

Mie University
01.2008

Skills

  • Analytical Testing: ELISA, qRTPCR, ddPCR based potency, Flow based potency
  • New assay development in Lentivirus, Retrovirus and AAV
  • Gene Therapy Viral Vector Product Characterization
  • Technology evaluation and correlation study CAPEX and budget management
  • Team building, critical thinking, mentoring, leadership and conflict resolution
  • Cell culture and cell-based assay
  • Preclinical study and surgical model development
  • Assay qualification
  • GMP/GLP Compliance
  • Project management
  • Technical writing including SOPs, Analytical Development Policy, and Protocol
  • Be a part of framing yearly budget and CAPEX and headcount determination
  • More than 5 years of supervisory and team management experience in advancing the development and characterization of Viral Vectors (AAV, LVV, and RVV) for cutting-edge cell and gene therapies Proven proficiency in devising analytical methods, particularly in the realm of potency assays utilizing both cell-based and ddPCR techniques, and adeptly detecting impurities within viral vectors by ddPCR and qPCR methods Playing an instrumental role in bolstering Process Development (PD) teams and facilitating cGMP production efforts Spearheading the leadership of a dynamic group of scientists dedicated to method innovation and refinement Illustrating the ability to thrive in fast-paced startup Contract Development and Manufacturing Organization (CDMO) environments, consistently delivering impactful results
  • Technical Implementation
  • Project Management
  • Proposal Writing
  • Resources Allocation
  • Expense Control
  • Process Improvement
  • Strategic Leadership
  • Key Relationship Management
  • Crisis Management
  • Budget Management
  • MS Office
  • Coaching and Mentoring
  • Critical Thinking
  • Performance Evaluations
  • Analytical Thinking

Intellectual Property Rights

Advanced Course in Intellectual Property Rights and Biotechnology, WIPO, Switzerland, 2007

Publications

https://www.linkedin.com/in/saikat75c/details/publications/

Languages

English
Full Professional
Hindi
Full Professional
Bengali
Full Professional
Japanese
Elementary

References

References available upon request.

Timeline

Associate Director, Analytical Development Lead

Genezen
01.2023 - Current

Senior Scientist, Analytical Development

Genezen
07.2020 - 12.2022

Quality Control - Biochemistry | Viral Vector Specialist

Novartis Gene Therapy
06.2019 - 07.2020

Senior Researcher | Gene Therapy and Preclinical Neuroscience

Feinberg School of Medicine - Northwestern University
06.2016 - 05.2019

Postdoctoral Research Associate | Neuropharmacology and Pain Research

Stony Brook Medicine
06.2013 - 05.2016

Postdoctoral Researcher | GI Smooth Muscle Cells

Harvard Medical School
04.2012 - 05.2013

PhD in Molecular Biology -

Mie University
Saikat Chakraborty