Harvijay S.

Product Engineer

United States12 yrs 1 mo experience

Most Likely To Switch

Key Highlights

12+ years in biophysical and structural characterization
Expert in monoclonal antibodies and recombinant proteins
Strong leadership in cross-functional teams

Stackforce AI infers this person is a Biotech professional specializing in protein therapeutics and analytical methods.

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Skills

Core Skills

Analytical Methods DevelopmentRegulatory ComplianceMolecular BiologyProject ManagementMicrobiologyMolecular Virology

Other Skills

Protein ChemistryStrategic CommunicationsProblem SolvingLeadershipContinuous ImprovementTenacious Work EthicIEXSECCE-SDSicIEFRP-HPLCRT-qPCRddPCRGood Laboratory Practice (GLP)Research

About

Scientist with 12+ years of experience in biophysical, structural, and analytical characterization of protein therapeutics, including monoclonal antibodies (mAbs) and recombinant proteins. I translate deep technical expertise—CGE, SEC, C/IEX, icIEF, MS, qPCR/dPCR, immunoassays—into strategies that ensure product quality, regulatory alignment, and program acceleration. I lead method development, validation, and tech transfer to de-risk programs, strengthen process understanding, and support both clinical development and commercial manufacturing in alignment with global regulatory standards. I work closely with Process, Formulation, and Quality teams to generate data packages that meets regulatory compliance and enable confident decision-making. These contributions shape analytical strategy, accelerate development timelines from discovery through commercialization, and help the organization advance therapies efficiently and compliantly toward patients. Passionate about advancing therapeutic innovation? Let’s connect!

Experience

Zoetis

Senior Scientist

Jun 2023 – Present · 2 yrs 9 mos · Michigan, United States · On-site

Performing analytical characterization of protein therapeutics—including monoclonal antibodies and recombinant proteins—using advanced analytical methodologies such as IEX, SEC, CE-SDS, icIEF, RP-HPLC, RT-qPCR, and ddPCR to evaluate product quality, stability, purity and efficacy.
Leading the development, qualification, validation, and transfer of multiple phase-appropriate analytical methods in compliance with global regulatory standards to support drug development and manufacturing pipelines.
Providing scientific and technical leadership within cross-functional teams, delivering critical analytical data and strategic insights to drive process development, optimization, and regulatory submissions.

Analytical Methods DevelopmentProtein ChemistryRegulatory ComplianceStrategic CommunicationsProblem SolvingLeadership+3

Rapidbio

2 roles

Scientist III

Jan 2022 – Feb 2023 · 1 yr 1 mo

Molecular BiologyProject ManagementMicrobiologyGood Laboratory Practice (GLP)ResearchAnalytical Methods Development+9

Scientist II

Jan 2022 – Apr 2022 · 3 mos

Analytical validation and clinical implementation of CLIA adherent laboratory developed tests (LDT) in BSL- 2 laboratory environment (qPCR assay for Monkeypox virus and STI panel).
Establishing interaction with infectious disease expert clinicians & physicians to expand the horizon of the research and development wing and drive the new product development effort.
Data analytics & Interpretation of infectious disease (COVID-19, Flu A & B, UTI, and STI, etc.) diagnostic RT-qPCR data to deliver the patient’s results through HIPAA-compliant LIMS platform.

MicrobiologyGood Laboratory Practice (GLP)PCRInterpersonal SkillsBioinformaticsResearch and Development (R&D)+4

Regional centre for biotechnology

Project Scientist II

Oct 2020 – Oct 2021 · 1 yr · Faridabad, Haryana, India

Managed the project, formulated & standardized the protocols for expression and purification of 'difficult to express' membranous proteins and designed constructs.
Adapted a sensitive and robust enzymatic activity assay for viral Methyltransferase and identification of it's potent inhibitors.
Bio-functional characterization of the target proteins through biophysical/biochemical techniques including DLS, SEC and Protein crosslinking.

Molecular VirologyMolecular ModelingWestern BlottingX-ray crystallographyMolecular BiologyProject Management+17

University of minnesota

Postdoctoral Associate

Mar 2019 – Jun 2020 · 1 yr 3 mos · Greater Minneapolis-St. Paul Area

Molecular cloning and site-directed mutagenesis of human herpes virus ribonucleotide reductases for protein expression in bacterial and mammalian expression systems.
Protein expression, purification, and functional characterization of different viral proteins and human restriction factors.
Biochemical and biophysical elucidation of the interplay of molecular interactions of herpes simplex virus ribonucleotide reductase and hAPOBEC3 restriction factors.

Molecular VirologyCancer ResearchMolecular ModelingWestern BlottingX-ray crystallographyMolecular Biology+21

Indian institute of technology, roorkee

Graduate Student (Ph.D.)

Jan 2013 – Dec 2018 · 5 yrs 11 mos · Roorkee · On-site

Thesis: Studies on alphavirus cysteine protease for antiviral drug discovery.
Discovered and validated the anti-CHIKV activity of two novel peptide-based inhibitory compounds. Authored and communicated research articles, and presented research findings at national & international conferences through poster & oral presentations.
Developed robust FRET-based enzymatic activity assays for inhibitor screening and hit identification, elucidated the structure of target proteins followed by functional characterization.
Gained high-level training in Project progress management, experimental designing and data interpretation, result analysis, and writing & communicating manuscripts and patent.

Good Laboratory Practice (GLP)Laboratory animal handlingInterpersonal SkillsResearch and Development (R&D)Polymerase Chain Reaction (PCR)Dose Administration

indian council of medical research (icmr)

Research Intern

Feb 2011 – Jul 2011 · 5 mos · NIOH - Ahmedabad Area, India · On-site

Research internship in the field of systemic Toxicology with a focus on scientific ethics, instrumentation handling and management, and hands-on experimental designing and setup.
Received training and gained proficiency in aseptic handling and analyzing biological samples.
Gained hands-on experience with conducting dose-dependent survival studies in laboratory mice to determine the adverse effect of environmental toxicants such as Chromium and Benzene).