SWETA KUJUR
Vadodara
Summary
Professional executive with comprehensive experience and readiness to excel in senior leadership. Skilled in strategic planning, team collaboration, and driving business growth. Renowned for adaptability, effective communication, and problem-solving. Adept at optimizing processes, enhancing productivity, and leading high-performing teams to achieve measurable results. Skilled in protein characterization activities that encompass techniques such as Capillary Electrophoresis, HPLC, LC-MS and HOS. Quality experience in data management, preparing and reviewing technical documents.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Sr. Executive-Executive Proteomics
Sun Pharmaceuticals Industry Ltd
09.2021 - Current
- Impurity characterization in DS and DP by HOS, CE and LC-MS technique
- Design experiments for Method Development and qualification for protein characterization in Capillary Electrophoresis (iCIEF, CIEF, CE-SDS, CZE), UV-second Derivative, Fluorescence, Free Thiol Estimation, Peptide mapping using UPLC and LC-MS, Near UV-CD, Far- UV-CD, Dynamic Light Scattering, Isoaspartate Quantification
- Troubleshooting for CE, HPLC, CD, HOS method and instrument related challenges (CE-SDS, CIEF, CZE, RP, SEC, CEX, PEP-MAP)
- Documentations: Preparation of Method Development and Qualification Report, Method of Analysis, Analytical Test Procedure, Characterization reports
Associate Scientist
Intas Biopharmaceuticals Ltd
04.2020 - 09.2021
- DS characterization by HOS and CE technique
- Design experiments for Method Development and qualification in Capillary Electrophoresis, UV-Spectroscopy, UV-CD, SEC-MALS and HPLC
- Troubleshooting for CE, HPLC, CD, HOS method and instrument related challenges (CE-SDS, CIEF, CZE, RP, SEC, CEX, PEP-MAP)
- US-FDA, EMEA, ANVISA query addressal
- Conduct experiments as per protocols to support analytical method development activities in GMP
- Documentations: Preparation of MQR, MOA, Test reports, MDQR, MTR, MTP, COT
- Analytical support to down-stream department for large scale process characterization, hold time harvest studies, satellite batch finalization, CT batch analysis
- Analytical support to DPD for stress-stability, Freeze thaw, buffer ranging studies supported in demonstration of bio-similarity study
- Analytical support to CMC for bio-similarity analysis between the innovator and in-house drug product and force degradation study to determine the degradation pathway of innovator and in-house product
- Establish specification of in-house DP and DS as per EU and US pharmacopeia in CE
- Comparative study of different pharmacopoeia-based methods as per regulatory guidelines
- Review/analyze data and information for technical correctness, accuracy; interpret and evaluate results
Tr. Research Associate and Research Associate
Intas Biopharmaceuticals Ltd
07.2017 - 04.2020
- US-FDA, EMEA, ANVISA query addressal
- Execution of experiments as per protocols to support analytical method development activities
- Analytical support to down-stream department for large scale process characterization, hold time harvest studies, satellite batch finalization, CT batch analysis
- Analytical support to DPD for stress-stability, Freeze thaw and buffer ranging studies supported in demonstration of bio-similarity study
- Analytical support to CMC for bio-similarity analysis between the innovator and in-house drug product and force degradation study to determine the degradation pathway of innovator and in-house product
- Design experiments for Method Development and qualification in Capillary Electrophoresis
- Complete task to ensure compliance with relevant regulatory bodies
Education
Master’s - Biotechnology
Indian Institute of Technology
Mumbai, Maharashtra01.2017
Bachelors’ - Biotechnology
St. Xavier’s College
Ranchi, Jharkhand01.2015
Skills
- LC-MS
- Capillary Electrophoresis
- HPLC
- Peptide mapping
- Cross-functional team coordination
- Report preparation
- Operations management
- Peptide Mapping
- Mail handling
- Performance improvement
- Project management
- Teamwork and collaboration
- Problem-solving
- Higher order structure
- Multitasking Abilities
- Documentation and reporting
- Analytical thinking
- Scheduling and coordinating
- Process improvement
- Written communication
- Team development
Certification
- AB Sciex Training, Darmstadt, Germany, 01/2020, Hands on experience on PA800 plus for instrument operation and Biopharmaceutical Applications
- Jaypee University, Himachal Pradesh, India, 2015, Hands on training on DNA, RNA isolation, amplification and sequencing
Research
Research Experience in Master’s, 2015-2017, Microbiology- Isolation and Identification of Unknown micro-organism from Fruit juice sample., Biophysics- Characterization of HSA and BSA spectrophotometrically using UV- visible, UV-CD and Fluorescence spectrophotometer., Genetic Engineering- Ligation of scoC gene in pET28α and transformation in DH5α strain of E.coli and expression of scoC gene in expression vector E.coli BL21 and purification of ScoC protein by Ni-NTA column.
Industrial Achievements
- Intas Biopharmaceutical’s Ltd., EMEA Approval, 07/2018, Analytical support for EMEA Audit queries as per schedule timeline of 180 days, and got EMEA approval for rHu-Peg-GCSF.
- Intas Biopharmaceutical’s Ltd., Award, 07/2018, Method development and transfer to QC as per US-FDA query and contribution to address EMEA Audit query.
- Intas Biopharmaceutical’s Ltd., Spot Award, 07/2018, Method development in brief duration for US-FDA queries response.
- Intas Biopharmaceutical’s Ltd., Award, 01/2020, Implementation of Chromeleon software across R&D.
- Intas Biopharmaceutical’s Ltd., Spot Award, 03/2020, CE-SDS method to separate and differentiate dipeg and dimer impurity in Peg-Filgrastim as a part of US-FDA queries response.
- Intas Biopharmaceutical’s Ltd., Award, 08/2020, For my valuable contribution in success of CT batches of Trastuzumab.
- Sun Pharmaceutical Industry Limited, Spot Award, 10/2022, Recognized for HOS method development for Characterization of protein.
Area Of Expertise
- Capillary Electrophoresis: CIEF, CZE, CE-SDS in both PA800 plus and Maurice iCE
- HPLC: SEC, RP, CEX, Pro-A, Peptide Mapping, IsoQuant, SEC- MALS
- HOS: UV-Visible, Fluorescence, UV-CD Spectroscopy, DLS
- LC-MS (Orbitrap, TOF-MS): Intact, Subunit, Sequence Coverage, MAM
- Reporting and documentation
Timeline
Sr. Executive-Executive Proteomics
Sun Pharmaceuticals Industry Ltd
09.2021 - Current
Associate Scientist
Intas Biopharmaceuticals Ltd
04.2020 - 09.2021
Tr. Research Associate and Research Associate
Intas Biopharmaceuticals Ltd
07.2017 - 04.2020
Master’s - Biotechnology
Indian Institute of Technology
Bachelors’ - Biotechnology
St. Xavier’s College
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