Karthik Chandu
Scientist Iii @Element Materials Technology
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WORK HISTORY
Scientist Iii @Element Materials Technology
Ann Arbor, MI, US
Designated LC-MS & HPLC SME : primary technical resource for instrument troubleshooting, method strategy, and cross-team guidance across all LC-MS and HPLC platforms. Lead LC-MS/MS peptide mapping of mAbs and peptide-protein bioconjugates: sequence confirmation, PTM identification, disulfide bond mapping, and biosimilar lot-to-lot comparability. Perform intact mass analysis, native protein analysis for structural characterization and subunit analysis (reduced/non-reduced) of protein biotherapeutics. Conduct sequence variant discrimination by bottom-up proteomics, resolving proteins differing by as few as one amino acid using targeted LC-MS/MS strategies. Lead HCP analysis, immunogenicity assessments, residual analysis (IPTG, P31R1), aggregation studies, and forced degradation (heat, pH, oxidative, photolytic) per ICH Q2(R2). Execute protein purity & quantitation: UV A280, extinction coefficient determination, SEC size variant analysis, and RPLC at protein level. Develop and validate LC-MS/MS methods for peptides, proteins, small molecules, and impurities aligned with ICH Q2(R2) and USP. Authored SOPs for Thermo Fisher Orbitrap, Agilent Bio QTOF, and Waters SEC-MALS. Authored technical guidance documents for Proteome Discoverer, Mascot, and Peptide mapping workflows. Certified trainer for HPLC, Triple Quad, Waters TQD, Waters QTOF, and Agilent QTOF. Lead OOS, OOT, deviation, and CAPA investigations in cGMP environment; authored OOS and RCA documentation in collaboration with QA and Technical management; took full ownership of RCA component of a cross-functional, lab-wide SCAR, delivering findings to senior management. Mentor junior scientists in experiment design, GMP documentation, data interpretation, and regulatory expectations.
EDUCATION
Jawaharlal Nehru Technological University, Hyderabad
Master's, Pharmaceutics
Osmania University
Bachelor's degree, Pharmacy
Cleveland State University
Doctor of Philosophy (PhD), Bioanalytical Chemistry
SKILLS
ABOUT KARTHIK CHANDU
Canadian Permanent Resident, Legally authorized to work anywhere in Canada. No sponsorship required.PhD-trained Analytical Scientist with 10+ years of experience in LC-MS and HPLC-driven method development, validation, and transfer across biologics, small molecules, and medical devices in CGMP CRO environments.I serve as the designated LC-MS & HPLC Subject Matter Expert (SME) at Element Materials Technology, primary technical resource for instrument troubleshooting, method strategy, and cross-team guidance across all platforms.Core expertise spans: Peptide mapping, HCP analysis, immunogenicity assessment, and peptide-protein bioconjugate characterization Intact mass, Bottom Up proteomics, PTM identification, disulfide bond mapping, subunit analysis Sequence variant discrimination by bottom-up proteomics; de novo characterization of custom molecules without reference standards Biosimilar lot-to-lot comparability and forced degradation studies (ICH Q2(R2)) Small molecule Method Development and Validation, residual antibiotics, process contaminants, excipients; ICH M10 bioanalytical validation in plasma/serum for clinical trials Protein & polymer characterization by SEC and GPC E&L analysis for medical devices, LC-MS, GC-MS, FTIR, GC headspace; residual polymer & solvent analysis per OOS, RCA, CAPA, deviation, and SCAR investigations in cGMP environmentsAuthored SOPs for Orbitrap, Agilent Bio QTOF, and Waters SEC-MALS; certified trainer across HPLC and LC-MS platforms. ACS Certified Peer Reviewer; active manuscript reviewer for peer-reviewed analytical science journals. Mentor junior scientists and drive continuous improvement across analytical workflows.Open to opportunities across Canada, CRO, CDMO, pharma, and biotech. Based in Windsor, ON; immediately available across Ontario (on-site, hybrid, or remote). Open to relocation anywhere in Canada for the right role.
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