Rajitha Doddareddy
Fort Washington
Summary
A dedicated researcher with extensive experience in large molecule biopharmaceuticals (biologics and vaccines), having spent 19 years in the industry, specifically 6 years in gene and cell therapy development. Possesses a strong background in various regulated bioanalytical techniques, approaches, and strategies.
Overview
23
23
years of professional experience
1
1
Certification
Work History
Principal Scientist
Merck
Spring House
05.2022 - Current
- Working in the PDMB department under the Exploratory Vaccines & Regulated Robotics group, focusing on biologics, vaccines, gene and cell therapy, and bioanalytical molecular method development to support preclinical and clinical studies.reclinical and clinical studies
- Our team is focused on developing, qualifying molecular methods to quantify DNA, RNA, and proteins in preclinical tissue biodistribution studies.
- Development Lead for programs related to biologics and Vaccines and oversee the regulated method bioanalytical data delivery and address regulatory questions
Sr. Scientist
Janssen R&D
SpringHouse
04.2020 - 05.2022
- Worked within the Pharmacokinetics, Pharmacodynamics and Immune Response Assay Development and Validation group in the Biologics Development Science
- This group is responsible for developing the methods that are used to understand the disposition properties of biotherapeutic drug candidates
- Worked within the Pharmacokinetics, Pharmacodynamics and Immune Response Assay Development and Validation group in the Biologics Development Science
- Gene and Cell therapy: Provided bioanalytical support and strategies to CAR-T, Adeno Associated Virus (AAV), Adenovirus, Oncogene vaccines, Bacteriophage, Oncolytic viral programs
Scientist
Janssen R&D
SpringHouse
05.2014 - 04.2020
Senior Associate Scientist
Janssen R&D
SpringHouse
11.2009 - 05.2014
Research Associate
Regeneron Pharmaceuticals
Tarrytown
04.2007 - 11.2009
- Worked as Research associate in Protein Chemistry Science group to develop and use different protein characterization and purification techniques in Pre-Clinical Development
- Experience with the method development of analytical SEC, LC/MS-MS, SDS-PAGE, PNGase F deglycosylation, 1D-IEF, 2D-PAGE electrophoresis, Western blot, and ELISA.
- I understood with LC/MS, MALDI-TOF, CE-SDS, C-IEF, and CE-Oligos to characterize antibodies and their glycosylated conjugates for IND and BLA filing.
- Contributed my effort in characterization of 5 different monoclonal antibodies, as part of CMC section of IND filing and in addition performed comparability lot testing for BLA filing
Research Associate
The Ohio State University
Columbus
07.2005 - 09.2006
- Two years of experience as a Research Associate in Biochemistry department at The Ohio State University
- Research on Cytochrome P450 BM-3 reductase domain (a fatty acid metabolizing enzyme in Bacillus megaterium) activities and interactions by using kinetic assays, chromatograph techniques, isothermal titration calorimetry, crosslinking reactions, and mass spectrometry analysis (Includes tryptic mapping and MS/MS analysis of the complex proteins)
- Learned expression and purification of different domains and complexes of the protein
Lab Assistant
Lab Corp of America
Columbus
01.2002 - 12.2005
- Specimen handling, verifying, sorting, accessioning and processing the human specimens received
Graduate Research Associate
The Ohio State University
Columbus
01.2004 - 06.2005
- Served as a Research Associate in the Department of Biochemistry as a part of master's thesis program
Graduate Teaching Associate
The Ohio State University
Columbus
01.2003 - 01.2004
- Teaching, grading and taking responsibility for non-major students and clarifying their questions in recitations
Research Assistant
The Ohio State University
Columbus
01.2003 - 12.2003
- Work experience in Plant, Cellular and Molecular biology department at OSU
- Work mainly focused on the extraction of DNA from plants, transformation, purification and digestion
Education
Master of Science - Quality Assurance/Regulatory Affairs
Temple University
Fort Washington, PA06-2014
Master of Science - Biochemistry
The Ohio State University
Columbus, OH06-1999
Master of Science - Molecular Biology
Sri Venkateswara University
India01-1999
Skills
- Immunoassay, LC-MS and Molecular techniques
- PD, PK, ADA and Cellular Kinetics
- Bioanalytical method validation
- Bioanalytical Strategy
- Biologics characterization
- Regulatory documentation
Accomplishments
JBIO “Janssen Innovation Award” Janssen R&D (Troubleshooting the PEG
Stresscopin clinical studies) 2014
JBIO “Janssen Vice President Research Award” for Outstanding Technical
Achievement For developing Ultrasensitive Immunoassay on Singulex platform 2018
JBIO “Janssen Innovation Award” Universal Quantitative Polymerase Chain
Reaction Method to Detect Integrated Lentivirus from CAR-T Products
Certification
- Wang W, Wang X, Doddareddy R, Fink D, McIntosh T, Davis H, and Zhou H, Mechanistic Pharmacokinetic/Target Engagement/Pharmacodynamic (PK/TE/PD) Modeling in Deciphering Interplay Between a Monoclonal Antibody and Its Soluble Target in Cynomolgus Monkeys, The AAPS Journal (# 2013) DOI: 10.1208/s12248-013-9545-8
- Wang W, McIntosh T, Jiang X, Doddareddy R, Dell E, Zhou H. Deciphering the In Vivo Performance of a Monoclonal Antibody to Neutralize Its Soluble Target at the Site of Action in a Mouse Collagen-Induced Arthritis Model Pharmaceutical Research April 2016, volume 33, Issue 4, pp 1040-1049
- Ehlinger C, Spear N, Doddareddy R, Shankar G, Schantz A. A Generic Method for the detection of Polyethylene Glycol specific IgG and IgM Antibodies in Human Serum. PMID: 31614128 DOI: 10.1016/j.jim.2019.112669
- Yang TY, Doddareddy R. Considerations in the development and validation of real-time quantitative polymerase chain reaction and its application in regulated bioanalysis to characterize the cellular kinetics of CAR-T products in clinical studies. Bioanalysis Vol 13 Issue 2Jan 2021 pp115-128
- White I, Tamot N, Doddareddy R, Ho J, Jiao Q, Harvilla P, Yang TY, Geist B, M. Borrok J, Truppo M, Ganesan R, Chowdhury P & Zwolak A. Bifunctional molecules targeting SARS-CoV-2 spike and the polymeric Ig receptor display neutralization activity and mucosal enrichment. mAbs, 13:1, 1987180, DOI: 10.1080/19420862.2021.1987180
- Amanda etal, Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development, AAPS Journal 2024
- Technical Considerations of Pharmacokinetic Assays for LNP-mRNA Drug Products by
RT-qPCR, AAPS Journal 2025 (In Review)
Timeline
Principal Scientist
Merck
05.2022 - Current
Sr. Scientist
Janssen R&D
04.2020 - 05.2022
Scientist
Janssen R&D
05.2014 - 04.2020
Senior Associate Scientist
Janssen R&D
11.2009 - 05.2014
Research Associate
Regeneron Pharmaceuticals
04.2007 - 11.2009
Research Associate
The Ohio State University
07.2005 - 09.2006
Graduate Research Associate
The Ohio State University
01.2004 - 06.2005
Graduate Teaching Associate
The Ohio State University
01.2003 - 01.2004
Research Assistant
The Ohio State University
01.2003 - 12.2003
Lab Assistant
Lab Corp of America
01.2002 - 12.2005
Master of Science - Quality Assurance/Regulatory Affairs
Temple University
Master of Science - Biochemistry
The Ohio State University
Master of Science - Molecular Biology
Sri Venkateswara University
Similar Profiles
Casandra L Santiago-NievesCasandra L Santiago-Nieves
IPT/Shop Floor Controller at MerckIPT/Shop Floor Controller at Merck
Shaquille JacobsShaquille Jacobs
Junior Software Engineer and Scrum Master at MerckJunior Software Engineer and Scrum Master at Merck
Avery PruittAvery Pruitt
Operations Technician at MerckOperations Technician at Merck
CYNTHIA ENID MORALES RAMOSCYNTHIA ENID MORALES RAMOS
Manufacturing Operator at MerckManufacturing Operator at Merck
Niya S. PowellNiya S. Powell
Corporate Services Consultant at CBRE, INCCorporate Services Consultant at CBRE, INC