Karteek Hebbar

To associate with an organization and grow professionally by leveraging my skill & knowledge and contribute towards growth of the organization and myself.

• Provided requisite deficiency response to queries raised by regulatory agencies of US (FDA), UK (MHRA), EU (EMA), Health Canada, south Korea (MFDS) and other markets (ROW) with scientific justification.
• Provided onsite expertise in Brazil to assist client with ANVISA-compliant method validation, ensuring regulatory compliance and successful implementation of analytical methods for GLP-1 peptide products.
• Successfully supported QP laboratory method transfer, ensuring timely validation and compliance with GMP requirements to facilitate on-time batch release.
• Enabled regulatory team by providing supportive data and documentation like method validation report, forced degradation report, comparative forced degradation report, comprehensive comparative characterization report required for submission.
• Guided team and cross-functional team to effectively address regulatory queries, ensuring compliance and timely resolution.
• Reviewed method validation report forced degradation report, comparative forced degradation report, comprehensive comparative characterization report, process validation report, batch manufacturing records, specifications, JOS and supportive documents required for submission as per regulatory requirement of different markets.
• Led and mentored teams in responding manufacturing queries, providing strategic guidance and expertise to drive successful outcomes.
• Writing and reviewing analytical method development reports, product development and technical reports.
• Developed in-house method for assay and related substances for proteins and peptides formulations using DoE and QbD approach.
• Developed FTIR method for characterization of secondary structure of biosimilar products.
• Developed Flow imaging methods to characterize sub visible particles present in Injectable using Micro Flow Imaging Instrument.
• Developed Intrinsic and Extrinsic fluorescence method for peptide characterization. Developed orthogonal methods for characterization of peptide formulation.
• Developed Size exclusion chromatographic method with Multi Angle Light Scattering Detector and QELS detector for molecular weight determination of protein and peptide formulations.
• Developed qualitative and quantitative method for analysis of excipients present formulation. Developed FT-NIR spectroscopic methods for identification and quantification of insoluble excipients present in solid dosage formulation, using chemo-metrics and multi variate analysis.
• Developed microscopic methods to understand particle size and shape present in innovator formulation.
• Well versed in characterization of powder, granules and tablets with respect to properties like porosity, pore size and structure, true density.
• Well versed in characterization of organoleptic properties of formulation with the help of sensory techniques like E-Tongue and E-Nose.
• Experienced in characterization of protein and peptide formulation by CD spectrophotometer, FT-IR and determination of absolute molecular weight by MALDI-TOF.
• Developed lozenges formulation for mucolytic agent using multiple excipients for masking bitter taste of API and to increase the disintegration time in mouth.
• Developed amorphous solid dispersion for poorly soluble API to increase the solubility and stability of drug product.
• Conducted pre-formulation studies to understand the interaction between excipients and active pharmaceutical ingredients.
• POC development for complex generics, identifying CQA (both CMA and CPP) through DoE.
• Supporting formulation team through technical due diligence, root cause analysis and by problem solving.
• Using DOE (JMP software) Designed and conducted pre formulation study for proteins, peptides to achieve the bio similarity criteria. Designed and conducted formulation and process development studies for proteins and peptides to achieve bio similarity criteria.
• Experienced Unscrambler, JMP software (DoE), MINI tab, Empower, Open lab, Chromeleon.

Received excellence award for Liraglutide Injection at Biocon.