GURURAJ SASALAMARI
Bangalore
Summary
Senior Scientific Manager at Biocon Limited with specialization in NMR method development and impurity characterization. Successfully led complex generics analysis and facilitated regulatory submissions. Strong analytical skills and effective communication foster collaboration with cross-functional teams to meet project objectives.
Overview
17
17
years of professional experience
Work History
Senior Scientific Manager
Biocon Limited
Bangalore
09.2021 - Current
- Responsible for leading higher order structural characterization of complex biopharmaceutical and pharmaceutical drugs.
- Structure characterization of Peptides, Semisynthetic API’s, Fermentation products, intermediates, KSM’s and small molecule API’s.
- Analytical support for the New product DMF filing.
- Characterization support for API R&D projects, CIP (Cost improvement programs) and AVD (Alternate vendor development) of existing products.
- Responsible to address the deficiencies for the filed and to be filed products.
- Responsible to provide characterization support for investigations and regulatory deficiencies/customer queries.
- Characterization of OOS, OOT and other trouble shoot investigations.
- Responsible to provide analytical support for new product selections, literature review for analytical elements.
- Responsible to support regulatory filing of existing products in new geographies-review of the documents.
- Experienced in handling of solid state NMR experiments.
- Characterization support for development of Oligonucleotide projects.
- Responsible to collaborate with contract lab facilities and research universities to execute experiments, including optimizing the experiments and reviewing the data and reports.
Senior Manager
Biological E Ltd.
Hyderabad
11.2017 - 09.2021
- Method development and qualification of 1D and 2D NMR identification and characterization for complex Generics such as Heparins and Low molecular weight Heparins.
- Mono and disaccharides compositional analysis of Heparin and Low molecular weight Heparins by 2D NMR.
- Preparation of Sameness assessment reports for LMWH by 1D and 2D NMR methods.
- Played a key role in transferring NMR methods for Heparins and LMWH to QC department.
- Provided characterization support for formulation and API projects.
- Developed NMR methodologies for assessment of bioequivalence for iron sucrose drug products.
- Data interpretation of DSC, TGA, UV, SOR and FT-IR techniques.
- Preparation and review of STPs, SOPs, protocols, Development, Qualification reports (Technical reports) and Sameness reports.
- Characterization of process impurities, stability samples (Drug substance & product), intermediates, forced degradation products and raw materials.
Scientist-III
United States Pharmacopeia India Pvt Ltd.
Hyderabad
11.2012 - 10.2017
- Structure elucidation of organic compounds, monomers and polymers using 1D and 2D NMR techniques.
- Characterization of unknown impurities generated during the process or forced degradation of drug substance or drug products by NMR, Mass and IR spectroscopic techniques.
- Experienced in solid state NMR data acquisition and interpretation.
- Identification and quantification of dietary supplements by NMR.
- Method development and validation for identification of vaccine polysaccharides by NMR.
- Worked as one of the collaborator for NIBSC projects.
- Hands on experience in spectroscopic techniques like MS, FTIR, UV and employed them in solving critical R & D projects.
- Preparation of Isolation and characterization reports.
- Experienced in handling scientific software’s like ACD (Structure elucidator & Fragmentor) and CMC (Structure elucidator) tools.
Research Associate
Biocon-Bristol-Myers Squibb R&D Center (BBRC)
Bangalore
01.2011 - 11.2012
- Characterization of unknown impurities by NMR and Mass spectroscopic techniques.
- Structure elucidation of various organic molecules by 1D and 2D NMR experiments.
- Structure elucidation for process impurities using Ion trap (MSn).
- Characterization of metabolite samples by NMR.
- UV, IR, SOR and Moisture content analysis.
- Complete Analytical Support to Synthetic chemistry projects.
Research Chemist
Laxai Avanti Life Sciences
Hyderabad
11.2009 - 12.2010
- Identification and Characterization of unknown organic molecules by Various 1D and 2D NMR experiments like 1H, 13C, DEPT (45, 90, 135), NOE, COSY, HSQC, HMBC and NOESY.
- Identification of various X-nuclei such as 19F, 11B, 15N, 31P.
- Quantification of various organic molecules by NMR.
- Calibration and regular maintenance of the instrument by refilling of liquid nitrogen.
- Routine LC-MS and mass analysis of various organic samples.
Project Trainee
AstraZeneca Pharma India Pvt Ltd
10.2008 - 11.2009
- Analysis of intermediates and final drug molecules by NMR, HPLC and GC.
- Purified bulk API by Preparative HPLC.
- Performed calibration of laboratory equipment’s as per the calibration program and GMP requirements.
- Handled classical instruments like KF Titrator, Polarimeter and PH Meter.
Education
Master of Science - Organic Chemistry
Gulbarga University
Gulbarga, Karnataka01.2008
Bachelor of Science -
Vijayanagar college
Hospet, Karnataka01.2006
Skills
- Structure characterization
- Sameness assessment
- NMR Method development
- NMR Method Qualification for biosimilars
- Complex generics
- Heparin and LMWH analysis by NMR
- Peptide Characterization
- Small molecules
- Impurity characterization
- Forced degradation products
- Data interpretation
- DSC
- FTIR
- CD techniques
- Statistical tools for Peptides HOS study
Accomplishments
- Received 'BE STAR' award for showcasing critical analytical skills in NMR method development for LMWH.
- Awarded three times for demonstrating technical excellence and quality during execution of various projects (USP Gold Impact award and USP Silver impact award).
- Received BBRC recognition award for showcasing competencies in generating customer value in Analytical science.
Publications
- The novel acid degradation products of losartan: Isolation and characterization using Q-TOF, 2D-NMR and FTIR, JPBA, 120, 02/20/16, 65-71
- Isolation and characterization of novel degradation products of Doxofylline using HPLC, FTIR, LCMS and NMR, JPBA, 140, 06/05/17, 1-10
Languages
- English
- Hindi
- Kannada
- Telugu
Personal Information
- Father's Name: Amareshwar.s
- Date of Birth: 09/04/85
- Nationality: Indian
- Marital Status: married
Timeline
Senior Scientific Manager
Biocon Limited
09.2021 - Current
Senior Manager
Biological E Ltd.
11.2017 - 09.2021
Scientist-III
United States Pharmacopeia India Pvt Ltd.
11.2012 - 10.2017
Research Associate
Biocon-Bristol-Myers Squibb R&D Center (BBRC)
01.2011 - 11.2012
Research Chemist
Laxai Avanti Life Sciences
11.2009 - 12.2010
Project Trainee
AstraZeneca Pharma India Pvt Ltd
10.2008 - 11.2009
Master of Science - Organic Chemistry
Gulbarga University
Bachelor of Science -
Vijayanagar college