Nalini Anand Email and Phone Number

• Develop, qualify and validate robust protein concentration determination and separation of purity and Impurities methods for biotherapeutic drug candidates for early and late clinical programs using cSDS reduced and non-reduced conditions.• Determine concentration of monoclonal antibody (mAb) or simple protein derived New Molecular Entities (NMEs) for mainly in-process testing using Spectrometry, SoloVPE, A280 and provide critical interpretation of results.• Author methods and method reports of chromatographic and electrophoretic results.• Handle multiple priorities in a fast-paced environment and work in cross functional biological and formulation teams. • Train other scientists on the cSDS, HPLC-SEC, RP, HIC, IE instrumentations and review ELN and reports.

• Responsible for Development and Validation of GC/FID, LC/UV, LC/CAD and Fiber Optic Dissolution Analytical Methods. • Expertise in the analysis of Raw materials, Intermediates, API, Drug products, and Stability products using Acquity, LC/UV, CAD, GC/FID, ECD and Headspace instruments and interpret data following strict guidelines on documentation to help Formulation, CD and R&D departments internally to improve quality of the drug products. • Proficient in troubleshoot technical issues and redevelop analytical method to improve robustness of the sample preparation and transfer method to Global Manufacturing Site (GMS) • Designed and executed gap analysis of several GMS -Forced Degradation Projects at the same time with API and different types of medications like Tablets, film coated tablets, capsules and injection liquid. Prioritized and managed the completion of stability projects accurately and issue Method Reports in a timely manner for regulatory submission.• IND validated a GC/FID method for GMS and transferred for NDA validation• Author of Validation Summary and Analytical Method Reports after IND validation of the methods with short time stability.• Review colleagues’ Lab note books, official validation protocols, Method Validation Plan, Validation Reports and Results Summary and recommend appropriate corrections then approve. Involve in OOT and OOS investigations related to potential data issues and deviations from standards.• Responsible for acquiring stability results from outside contract labs and report results in PDLIMS following LIMS specifications for Stability samples, Drug Substance, Drug Products and Reference Standards. • Review and approve PV/PM and repair of GMP/GLP systems HPLC/GC hardware testing by outside vendors to conformance to FDA 21 Part 11.

• Developed method for a CAPA (Corrective and Preventive Action) project to improve QA systems for stability and product/package compatibility for Listerine mouth wash products using IC-2000 and contributed to a poster presentation and method report on the accomplishment.• Performed chromatographic analysis of consumer products using HPLC, LC-MS/MS, GC/MS, IC-2000, CAD instruments and interpreted data following Good Documentation Practices. • Analyzed Raw materials, formulation products, finished products, and stability products for R&D purposes using Analyst 5.2, Empower Pro, ChemStation, and Chromeleon software. • Supported the R&D group for platform studies by analyzing baby care, wound care, skin care semisolid cream samples for developing and/ or improving consumer products. • Developed methods using a range of analytical techniques for quantifying compounds and their metabolites with impurities for stability tests.• Carried out analysis to assist in trouble-shooting problems associated with analytical methods and production process at the contractor manufacturing sites. Carried out analysis of complaint samples and competitor’s samples. • Worked on cross-functional project teams to troubleshoot and identify technical issues and documented the results and authored reports on findings.

Prepared samples using numerous techniques Solid Liquid, Liquid Liquid, and Protein precipitation from biological liquids Plasma, Serum, Blood, CSF, Urine and Analyzing small organic compounds with excess salts by Aquity UPLC. Independently setup and started an analytical run, including MS setup and programming of the test method procedure into the HPLC. Tuned for compound identification and optimization for high resolution in LC-MS/MS. Basic Troubleshot GC, HPLC, and UPLC