Summary
Overview
Work History
Education
Skills
Websites
Notable Accomplishments And Expertise
Analytical Instrumentation
Publications
Timeline
Generic

VENKATARAMANA (VENKAT) KONDA

Franklin,MA

Summary

Analytical scientist with over 14 years of diverse experience across various modalities including small molecules (DS and DP), nucleic acids (Antisense Oligonucleotides, siRNA, sgRNA and mRNA), cell and gene therapy products. Skilled in method development, validation, transfer and optimization for a wide range of analytical techniques and instrumentation. Demonstrated expertise in ensuring compliance with regulatory standards and guidelines while delivering high-quality analytical data. Proficient in problem-solving and troubleshooting complex analytical challenges. Strong track record of collaboration with interdisciplinary teams to support research, development, and commercialization efforts. Committed to staying abreast of emerging technologies and methodologies to drive innovation and enhance analytical capabilities. Excellent communication and leadership skills, with a proven ability to effectively manage projects and mentor junior staff members.

Overview

15
15
years of professional experience

Work History

Senior Scientist

CRISPR THERAPEUTICS
06.2022 - 12.2023
  • Supported the development of exa-cel, the first CRISPR gene editing product approved by both the BLA and MAA for severe sickle cell and transfusion dependent beta thalassemia diseases
  • Directed PPQ-related analytical activities for critical components such as sgRNA and cas9 protein for exa-cel and other immuno-oncological CRISPR CAR-T therapies, leading to the successful validation of methods for commercial use
  • Led technology transfers and provided oversight for qualification and validation of analytical assays within the organization and at CMOs and CTLs
  • Designed and executed experimental protocols for mRNA-LNP based analytical assays, implementing new technologies per ICH guidelines
  • Closed numerous OOS and OOT cases at external sites, showcasing strong problem-solving skills
  • Authored, reviewed, and revised technical documents for GMP lot release, characterization testing, change controls, and regulatory submissions
  • Collaborated with internal and external teams, contributing as an SME for matrix-based productCMC-teams.

Scientific Technical Leader II

EDITAS MEDICINE
08.2021 - 06.2022
  • Provided technical expertise for analytical method development supporting CRISPR cell and gene therapy medicines
  • Collaborated with internal PAD teams, determining critical material attributes and establishing raw material specifications
  • Reviewed and approved supporting documentation for developed analytical methods, ensuring data integrity
  • Conducted raw material risk assessments and identified and assessed regulatory risks and mitigation plans for global submissions, finding upgrades as appropriate
  • Supported quality with data, technical assessments, and expertise for various aspects, including trending data and assay validation.

Scientist

ALNYLAM PHARMACEUTICALS
08.2019 - 08.2021
  • Designed experiments for siRNA product development, method validation, transfers, and feasibility studies
  • Served as a technical expert for troubleshooting in a cGMP environment
  • Applied statistical methods such as JMP for data review and trend identification
  • Proposed specifications for late-stage and commercial programs such as patisiran (ONPATTRO), givosiran (GIVLAARI), lumasiran (OXLUMO), and vutrisiran (AMVUTRA), authoring justification reports
  • Demonstrated knowledge of a wide range of analytical techniques and authored regulatory submissions
  • Managed recruitment, training, and mentoring of co-op students.

Research Scientist II

NITTO DENKO AVECIA
08.2015 - 08.2019
  • Led as an analytical scientist for siRNA and Antisense Oligonucleotide related projects, effectively communicating with clients
  • Designed and executed laboratory experiments for oligonucleotide method development and validation
  • Authored validation and qualification protocols and reports based on phase-appropriate molecules and ICH guidelines
  • Served as an SME for LCMS-based methods for purity analysis of oligonucleotides
  • Demonstrated hands-on expertise in various analytical techniques and managed instrument troubleshooting.

Analytical Chemist

JOHNSON MATTHEY PHARMA SERVICES
08.2013 - 08.2015
  • Developed, qualified, and validated methods for pharmaceutical products (small molecules), ensuring compliance with internal SOPs and ICH guidelines
  • Authored technical documents, including method validation and qualification protocols and reports
  • Maintained and troubleshooted analytical instruments.

Chemist I

PHARMACEUTICS INTERNATIONAL INC. (PII)
06.2010 - 08.2013
  • Executed and validated protocols for dissolution studies and developed dissolution methods
  • Performed pharmaceutical analysis of in-process, finished products, and stability samples
  • Operated and maintained various analytical instruments
  • Trained interns and subordinates on different instruments and analytical techniques.

Pharmaceutical Scientist

CAPRICORN PHARMA INC.
03.2009 - 06.2010

Education

B.S. - Pharmaceutical Sciences

JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY

M.S. - Chemistry

YOUNGSTOWN STATE UNIVERSITY

Skills

  • Analytical Method Technology Transfer
  • Team leadership
  • Cross-functional collaboration
  • Matrix-based product-CMC teams
  • Training and mentoring
  • Late-stage analytical representation
  • Reference material qualification
  • Experimental protocol design
  • Characterization assays
  • Phase-appropriate qualification
  • Nucleic Acid Expertise:
  • ASO, siRNA, and sgRNA
  • MRNA-LNP analytical development
  • Raw material testing
  • Critical material attributes
  • Education and Training:
  • Co-op student management
  • Quality Control:
  • CAPA effectiveness monitoring
  • Change controls
  • GMP lot release
  • Data review
  • Molecular Biology:
  • DNA isolation and purification
  • QPCR
  • ELISA
  • Aseptic techniques
  • Gel electrophoresis
  • SDS-PAGE
  • Documentation:
  • Technical document authoring
  • Specification justification reports
  • Project Management:
  • Project oversight
  • Vendor Management:
  • CDMO and CTL collaboration
  • External partnerships
  • Vendor oversight
  • Contract manufacturing
  • Regulatory Compliance:
  • FDA, EMA, and ICH knowledge
  • Regulatory document support
  • CMC strategy development
  • CMC submission documents for commercial products
  • Project Management
  • Scientific Writing
  • Assay Development
  • Results Analysis
  • Laboratory Techniques
  • Research Methods
  • Data Analytics
  • Root Cause Analysis

Notable Accomplishments And Expertise

  • Effective analytical support for the first CRISPR gene editing product approved by both BLA and MAA.
  • Developed and executed global regulatory strategies, authoring analytical and specification sections for multiple regulatory submissions (IND, CTA, BLA, and MAA).
  • Successful closure of OOS and OOT cases at external sites.
  • Expertise in a wide range of analytical techniques and problem-solving.
  • Leadership role as an analytical scientist at Nitto Avecia, Alnylam, and CRISPR Therapeutics.
  • Mastered various operating software: Empower 2 and 3, Chem Station, Chromeleon, Mass Lynx, etc.
  • Thorough knowledge of dissolution studies, pharmaceutical analysis, and wet chemistry techniques.

Analytical Instrumentation

  • HPLC and UPLC chromatography (IEX, RP, SEC; Agilent and Waters).
  • LC-MS (Agilent and Waters) - single quadrapole.
  • ICP-MS and ICP-OES.
  • GC (headspace and direct).
  • Capillary gel electrophoresis (CGE).
  • Dissolution apparatus (I and II).
  • UV-VIS spectrophotometer.
  • Ion chromatography (IC).
  • KF titrator.
  • Detectors used: VWD, MWD, PDA, CAD, conductivity, and fluorescence.
  • Wet chemistry techniques: FT-IR, refractometer, and particle size analyzer.

Publications

Jasenec A, Barasa N, Shaik N, Moparthi S, Konda V, Caguiat J. Proteomic profiling of L-cysteine induced selenite resistance in Enterobacter sp. YSU. Proteome Sci. 2009 Aug 28; 7(1):30.

Timeline

Senior Scientist

CRISPR THERAPEUTICS
06.2022 - 12.2023

Scientific Technical Leader II

EDITAS MEDICINE
08.2021 - 06.2022

Scientist

ALNYLAM PHARMACEUTICALS
08.2019 - 08.2021

Research Scientist II

NITTO DENKO AVECIA
08.2015 - 08.2019

Analytical Chemist

JOHNSON MATTHEY PHARMA SERVICES
08.2013 - 08.2015

Chemist I

PHARMACEUTICS INTERNATIONAL INC. (PII)
06.2010 - 08.2013

Pharmaceutical Scientist

CAPRICORN PHARMA INC.
03.2009 - 06.2010

B.S. - Pharmaceutical Sciences

JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY

M.S. - Chemistry

YOUNGSTOWN STATE UNIVERSITY

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