Biologics CMC development of clinical candidates for IBD/Inflammation and related therapeutic areas - DS & DP control strategy including methods, testing, advanced characterization, structure-function correlation, comparability, subcutaneous and high concentration formulation development, mAb developability, ultra-accelerated clinical development, GMP analytical operations and compliance, knowledge management, CDMO partnership, and risk-based decision making.

• Analytical development leadership role for cell therapy DP method development/validation, tech transfer, assay automation, analytical control strategy & risk-based decision making, DP characterization, stability, comparability, non-GMP testing, and regulatory submissions for several CAR T clinical development assets. • Provided life-cycle management analytical support for commercialized cell therapy products (Abecma®, Breyanzi®). • Led multiple analytical functions (method dev/val, testing, automation); Established strategy for building high performing teams, developing next-level leaders, talent retention & succession; Implemented streamlined technical and business operations including CapEx, budget, laboratory space & usage, portfolio dashboard & performance metrics. • Built strong partnership across functions internally with process, quality, manufacturing, regulatory and externally with CROs & suppliers.

- Leadership role developing strategy and creating new capabilities in biologics development such as AI-enabled E2E method performance monitoring, AI-based data analytics and automated reports. - Strategic lead for commercialization of biologic assets - driving both internal and external alignment with key stakeholders on analytical development and testing strategies. - Successful BLA approval of Opdualag® (mAb combination DP).- Led the biologics impurity Center of Excellence, accountable for analytical control strategy of biologics, antibody, fusion protein, antibody drug conjugate, AAV, gene therapy process related impurities, method development & validation from early stage through BLA and commercialization. Business strategy and operations including CapEx, department budget, talent development, succession planning, performance metrics, portfolio dashboard, risk management, and operational excellence.- Served as a core member in the governance forum for integrated biologics technical review, for clinical phase-appropriate & commercial technical strategy of all BMS biologics assets.

• Leadership role for biologics (mAb/ADC/bispecific/fusion/gene/AAV) DS/DP analytical method development and validation, stability, analytics for formulation/process development, and formulation characterization. • Managed technical deliverables, IP & scientific knowledge generation of many biologics/gene assets from early stage through BLA and commercialization.• Leader and sponsor of new technology development team; Portfolio program management; Technical strategy for regulatory filing; Streamlining business processes (e.g., platform technologies & methods; accelerating FIH); Building strong cross-functional interfaces. Business strategy and operations including budgeting - CapEx & OpEx, performance metrics, succession planning, portfolio dashboard, hiring & talent development, risk management & scenario planning, and operational excellence.

• Led and created the capabilities of this function, built a new group for analytics of biologics formulation dev & DP process; built/modernized two centers of excellence for biophysical and mass spectrometric characterization of biologics, ADC, and combination products.• Established core capabilities for protein particle characterization, Structure-Function, Elucidation of Structure, new paradigm for Critical Quality Attribute (CQA) assessment and analytical control strategy.• BLA/MAA/JNDA preparation, filing, and successful approval for Opdivo® and Empliciti®. • Advanced capabilities to support an exponentially growing biologics clinical portfolio. Creating new business process, developing business strategy and operations including budgeting - CapEx & OpEx, performance metrics, succession planning, portfolio dashboard, hiring & talent development, risk management & scenario planning, and operational excellence.

Development of Biotherapeutic drugs and vaccine for improving human health. Worked in Pfizer and its legacy companies (Pharmacia/Upjohn) in various roles with increasing responsibilities in formulation, DP process & analytical characterization for clinical CMC development. • Managed technical deliverables for many biologics & related assets including fusion protein, antibody, ADC, pegylated protein, RNA, lipid-based NME, complex API, and vaccine clinical/commercial assets. Developed clinical formulation & DP process for many biologics assets. • Built Biophysical characterization CoE including protein particle characterization; Supported Elucidation of Structure (S3) for dozens of INDs, IMPDs & CTAs.• Served as portfolio program DP lead of several early- & late-stage programs; Led innovation and technology development projects; Led biophysical & structural characterization; Supported life cycle management, CMC regulatory submissions and responses, and BD due diligence activities. • Developed and introduced mAb “platform formulation” at Pfizer. Led several scientific teams for mitigating complex challenges in protein conjugate development/manufacturing/regulatory.• Co-led Prevnar 13® vaccine (polysaccharide conjugate) commercial mfg & scale-up for flocculation problem-solving including effect of adjuvant. Supported clinical formulation/DP development of protein subunit vaccines (e.g., Meningococcal B – Trumenba®).• Supported pivotal/commercial development of tremelimumab (Imjudo®) & a pegylated FAB (Cimzia®) and life cycle management of Genotropin® (human growth hormone) & Somavert® (pegylated hGHRA).• Developed and implemented the "Biotech Investment Paradigm", a key initiative that led to major resource savings & enabled speed (>50% time reduction).• Co-Chaired Pfizer global Comparability Expert Working Group. Served as a Liaison with Research (Discovery) Units globally across sites.• Elected to Chair the Biotechnology Section of AAPS (2012).

Design and development of proteomics methods for discovery of human disease markers (biomarkers); Proteomics of healthy vs cancer human tissues & in rat models; Mass spectrometry, chromatography, electrophoresis. Isolation & characterization of organelles and associated proteins.