Arpita Shingala
Summary
Accomplished Scientist with extensive experience at pharmaceutical industry, specializing in biologics separation and analytical method validation. Proven track record in ensuring cGMP compliance and fostering team collaboration. Adept in chromatography techniques and effective communication, driving successful outcomes in clinical development and quality control processes.
Overview
19
19
years of professional experience
Work History
Scientist in Biologics GxP – ASO
Bristol-Myers Squibb
06.2022 - Current
- Conduct biologics separation assays on monoclonal antibodies, fusion proteins, antibody-drug conjugates (ADCs), and fixed drug ratio combination (FDRC) products to aid in the clinical development of immuno-oncology and oncology therapies.
- Perform electrophoretic and chromatography testing of biologics, including iCIEF, CGE, SE-HPLC, RP-HPLC, IEX, N-Glycan analyses, and peptide mapping, to support R&D activities such as clinical release and stability, reference material qualification, and product development.
- Perform analytical method qualification and validation as per approved protocols, as applicable.
- Perform compendial methods, wet chemistry techniques, such as protein concentration by UV/Vis spectroscopy (A280), and other relevant methods.
- Demonstrate practical knowledge of analytical techniques to develop phase-appropriate, robust, and reproducible analytical methods for GMP clinical laboratory.
- Review analytical data for accuracy, completeness, and cGMP compliance. Data includes ELN notebooks, chromatography, and electronic data/primary data.
- Apply the 5S (five-step) methodology to organize and optimize the workspace to become more productive.
- Ensure compliance with GLP/GMP regulations, corporate policies, and site procedures.
- Review technical documents, analytical methods, reports, and protocols for accuracy and completeness.
- Communicate potential issues to management promptly and clearly.
- Report and review analytical results in PDLIMS.
- Led team engagement activities for 35 department members, fostering a collaborative culture focused on connection, shared learning, and a supportive team environment.
- Contract with Thermo Fisher from June 2022 to October 2024.
Senior Scientist in R&D
Merck & Inc
02.2021 - 05.2022
- Support testing of release, stability, process characterization samples, and cell-line development testing.
- Experience with charge variant analysis of monoclonal antibodies using techniques like ion exchange chromatography utilizing HPLC, and quantification of residual DNA in drug substance and in-process samples by PrepSEQ DNA extraction and qPCR.
- Proficient in using analytical software, including Empower and ChemStation.
- Enter laboratory testing results in RLIMS/LIMS to ensure stability trends.
- Follow good documentation practices and the utilization of electronic laboratory notebooks (ELN).
Associate Scientist in QC
Catalent Pharma Solutions Inc.
10.2016 - 02.2021
- Conducted analytical testing with HPLC/UPLC instruments using separation chromatography techniques.
- Performed Dissolutions, Assays, Related Substance (RS), Content Uniformity, Blend Uniformity, moisture determination by KF, testing as per in-house, USP or EP monograph.
- Performed testing on in-process, released, and stability samples using analytical methods.
- Reviewed of analytical data for accuracy, completeness, and cGMP compliance. Data includes lab notebooks, logbooks, chromatography, and electronic data/primary data.
- Mentored newer analysts on testing procedures and good documentation in accordance with cGXP & compliance.
- Proficient in using Total Chrome and Chem Station software.
- Prepared and reviewed stability summaries for trending the data and certification of analysis for release samples.
- Document and maintain of accurate and complete procedure, results, and conclusion of the experiment.
- Conducted analytical investigation for deviation, OOT and out of specification results using Global Trackwise System.
- Gathered quantitative and qualitative data of analysis for investigation.
Quality Assurance Documentation Specialist
Tris Pharma LLC
02.2011 - 01.2014
- Prepared annual product review (APR) for commercial products.
- Created stability report for submission purpose and initiated change control.
- Prepared and revised specification for API, raw material, and packaging component as per USP/NF and as well as applicable company compliance guidelines.
- Prepared and revised specification for in-process, stability, and finished product with compliance guidelines.
- Supported the site with preparation, circulation, and handling of specifications and methods.
QC Scientist
CORE Pharma LLC
07.2008 - 03.2009
QC Chemist
Actavis LLC
07.2006 - 02.2008
Education
M.S. - Industrial Pharmacy
Long Island University
Brooklyn01.2009
B.S. - Pharmacy
Sarvajanik Pharmacy College
Mehsana, India01.2004
Skills
- Biologics separation
- Protein concentration determination by SOLOVPE
- Analytical method validation
- Chromatography techniques
- Electrophoretic
- GMP compliance (cGMP and ICH)
- Quality control processes
- Data analysis and interpretation
- Dissolution Apparatus
- Disintegrating Apparatus
- FTIR and Karl-Fischer
- Problem solving
- Accurate data entry
- Quality Regulations
- Team building
- Effective communication
Timeline
Scientist in Biologics GxP – ASO
Bristol-Myers Squibb
06.2022 - Current
Senior Scientist in R&D
Merck & Inc
02.2021 - 05.2022
Associate Scientist in QC
Catalent Pharma Solutions Inc.
10.2016 - 02.2021
Quality Assurance Documentation Specialist
Tris Pharma LLC
02.2011 - 01.2014
QC Scientist
CORE Pharma LLC
07.2008 - 03.2009
QC Chemist
Actavis LLC
07.2006 - 02.2008
M.S. - Industrial Pharmacy
Long Island University
B.S. - Pharmacy
Sarvajanik Pharmacy College