Kamalapriya Gnanasivam

314-***-**** ad3riz@r.postjobfree.com linkedin.com/in/priya-gnanasivam-93256822 Quality Scientist

Accomplished and detail-oriented Research Scientist developing methods by employing comprehensive lab techniques, authoring GLP/cGMP documents, and reviewing FDA filing documents for successful early and late-stage biopharmaceutical manufacturing. Utilize such techniques in dynamic and interdisciplinary environments including R&D labs, GMP labs, and CRO/CMO to support the launch of successful commercial drug products. Demonstrate exceptional proficiency in collaborating with teams to achieve corporate objectives while effectively managing concurrent projects. AREAS OF EXPERTISE

ICH Guidelines and Regulatory Compliance LIMS GLP cGMP EPA OSHA Author Regulatory Documents, Deviations, QC OOS and OOT investigations Quality Control Data Review, Batch records Data Verification of FDA Filing Documents LEAN Blue belt Six Sigma Kanban, Gemba Team Player Cross-Functional Team Collaboration MS Office (Word, Excel Spreadsheet, PowerPoint)

Lab Techniques: Antibody Development & Purification, Drug Product CQA Method Development, Biomarker Multiplex, Meso Scale Discovery ( MSD), Nephelometry, ELISA, Conjugation of the Resin and Beads, Biotinylation, Antibody Purification, Gel Electrophoresis, Western Blot Chromatography and Instrumentation: HPLC Agilent - Chem station, GC Varian - Galaxie, Shimadzu-Class VP, GE Akta Prime/Biorad - Affinity Purification, Spectroscopy - Spectra Max Plus and 384 microplate reader - Softmax Pro GxP, MSD platform, Bio-Rad Densitometer - Quantity one Software, Luminex Xponent, Millipore Sigma Analyst Software, Orion, LIMS, WATSON

PROFESSIONAL EXPERIENCE

Pfizer, St. Louis, MO June 2020 - Present

Scientist, October 2022 - Present

Authored INX Test Methods, Protocols, Reports, and approval of documents in GDMS. Reviewed various FDA Filing Documents from Pre IND to BLA (Pneumococcal Pre IND-Filing, Meningococcal Filing Documents, Respiratory Syncytial Virus Prefusion ELISA for MAA Query, Qualification and Bridging of Critical reagents, Co-developed critical quality attribute assessment Test Methods, )

• Led the optimization and bridging of a Pneumococcal vaccine program, leading to the identification of optimal dilution conditions for 20 antibodies critical for drug product manufacturing support.

• Co-developed the Pneumococcal Total antigenicity method. Optimized suboptimal serotype antigenicity conditions in the complex Conjugated test method.

• Trained analysts in antibody bridging, data analysis, and the Design Expert Statistical Model for antibody characterization to meet the light-speed project timeline.

• Managed stability studies for early and late-stage drug substance and drug product manufacturing. Applied data analysis to execute post-stability evaluations for establishing shelf life.

• Spearheaded the successful execution of method qualification and critical reagents bridging across multiple vaccine programs, ensuring the timely completion of regulatory filing.

• Curated metadata for qualified antibodies to streamline the generation of Critical Reagent Certificates within the Laboratory Information Management System (LIMS)

• Collaborated across multiple departments (Stability, Manufacturing, QC) to revise SOPs, optimize Lab data workflow for Nephelometry instrument GMP compliance, and ensure lab safety audit readiness. Senior Associate Scientist, June 2020 - October 2022 Assay execution for early-phase and late-stage vaccine programs, bridging critical reagents, authoring and approval of reference material bridging protocol and reports, critical reagent reevaluation, and expiration date extension. Kamalapriya Gnanasivam ad3riz@r.postjobfree.com Page Two Senior Associate Scientist, continued

• Formulated comprehensive protocols and reports, actively driving the advancement in the characterization of critical reagents for the vaccine programs.

• Co-led the establishment of Reference Material equivalence for the Respiratory Syncytial Virus (Abrysvo), spearheading the authoring of the bridging protocol, execution, and conducting data analysis. Collaborated with a statistician to precisely define confidence intervals to establish robust acceptance criteria.

• Conducted meticulous FDA filing documents data review and created memos for RRF applications to ICH batches, ensuring on-time regulatory filing.

• Executed the biotinylation, bead conjugation, and qualification of critical reagents for the Clostridium difficile program to support manufacturing.

Thermo Fisher Scientific (CMO), St. Louis, MO August 2018 - June 2020 Project Lead

Liaison between quality control and client site program manager in support of commercial and Clinical biopharmaceutical manufacturing. Authored analytical method transfer, validation protocol/reports, and product specifications per ICH Guidelines for biopharmaceutical manufacturing.

• Collaborated with QC-specific program management to schedule workflow and meet client-specified timelines.

• Trained analysts and performed HCP and ProA ELISA assays to support data for Release and Stability specifications in the clinical phase.

• Compiled and delivered weekly project updates to client management through project meetings.

• Coordinated with the microbiology testing labs to conduct mycoplasma and bioburden testing, entering the results into release specification documents for clinical trials. Eurofins Pharma Bioanalytical Services (CRO), St. Louis, MO October 2016 - August 2018 Method Development and Validation, Scientist

Managed the development, validation, and transfer of Anti-Drug Antibody (ADA), Biomarker immunoassays based on ELISA, MSD Platform. Data generation of clinical phase trials for FDA and other regulatory submissions.

• Executed the development, validation, and data analysis processes, and authored validation protocols, reports.

• Communicated project updates clearly and promptly to external clients. Millipore Sigma, St. Louis, MO January 2011 - October 2016 R & D, Antibody Characterization & Immunoassay Platform, Scientist Expertise in AKTA Chromatography Antibody purification, Resin conjugation, Bead conjugation, Biotinylation, Antisera screening, Antibody characterization, LEAN six sigma blue belt.

• Developed and characterized antibodies for Multiplex and ELISA immunoassays, enhancing support for development and manufacturing of multiplex ELISA kits.

• Co-identified Protein expression forms, conducted protein carrier conjugation, and supported custom protein expression projects.

• Evaluated antibody pairs for affinity and specificity, identified custom new antibody pairs for high profile targets and cytokine replacements- Irisin, Betatrophin, FABP4, GROA.

• Initiated and executed a blue belt project for antisera and protein management. Kamalapriya Gnanasivam ad3riz@r.postjobfree.com Page Three ADDITIONAL RELEVANT EXPERIENCE

Monsanto, St.Louis, MO

Regulatory Protein Expression Platform, Immunoassay Analyst Lead bridging, Validation, and Expiration date extension of ELISA reagents

• Executed ELISA Method Optimization and Validation of transgenic plant protein-Dicamba – monooxygenase and created a successful data package for regulatory submission.

• Involved in the development of immunoprecipitation and Western detection methods to establish equivalence between microbial and high-yield intrinsic plant protein. Crop Analytics, Proteomics, Research Biochemist

• Co-developed a field-deployable method for identifying high Beta-Conglycinin Soy protein using reverse-phase Agilent HPLC.

• Assisted in assembling and implementing the Crop Analytics Mobile Laboratory (CAML) units for rapidly measuring linolenic acid using Varian Gas Chromatography.

• Actively participated in the evaluation of food aromas using the Alpha Multi Organoleptic system - E-nose. EDUCATION AND CERTIFICATION

Master of Science, MS in Biochemistry & Environmental Science Bharathiar University, India

Bachelor of Science, BS in Biochemistry

Bharathiar University, India

Certification in Chromatography techniques

AWARDS, RECOGNITION, AND INVOLVEMENT

• Lab safety audit, EHS Ergonaut, Emergency squad member, Monsanto outreach member

• PEDCOE (Pfizer Pediatric Center of excellence), Pfizer biotech connect symposium, ARD change culture Team member.

• Received Pfizer BRAVO awards:

Timely completion of Meningococcal PRM/WRM Release/Characterization/Bridging, RSV DAI Study and eLN review, timely approval of the Pneumococcal Nephelometry Test method to get transferred to Manufacturing, Pneumococcal Light speed DP method development from VRD to ARD to PGS-QC

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