• Oversee CMC activities for 6+ biologics programs, including technical development (process, product and analytical control strategy), GMP / USDA manufacturing operations, and CMC quality areas from early clinical stages to commercialization of pipeline programs.• Manage clinical supply chain, CMC project management, and CMC regulatory functions to ensure seamless operations and compliance . • Lead a team of experts to drive innovation, efficiency, and quality in CMC development and manufacturing processes.• Ensure regulatory filings are in accordance with FDA, EMA and USDA regulations & guidances• Oversee external CDMO, CRO and 3P partnered activities.• Served as the Senior VP, CMC Development and Manufacturing till March 2024 at Invetx prior to acquisition of the company by Dechra; Member of the Invetx executive leadership team that supported the successful due-diligence and integration activities.

CMC Consultant providing services to human therapeutics companies in the following areas:*Independent consultant for Biologics companies; Supported authoring of analytical and quality sections for a BLA filing in early 2022 (now an approved product) and drug product sections for multiple IND/ IMPD and major amendment submissions.*QbD based biologics development and manufacturing strategy*Biologics process & analytical control strategy*Developability assessment, Early to commercial stage formulation, primary container and combination product development*DP process development and characterization*DP cGMP manufacturing and process validation*Biologics analytical method development, qualification/ validation and Biophysical characerization*Process/ analytical comparability*Clinical to commercial specifications setting *Extractables/ leachables monitoring.* IND, IMPD and BLA CMC section authoring

The EAB members have the major responsibility for peer review of manuscripts, participate in the annual selection of Ebert Prize finalists for the American Pharmacists Association, and provide guidance to the Editorial Team on current and emerging trends in the pharmaceutical sciences.The primary responsibilities of the SAEs are to evaluate the significance and the originality of the scientific content of manuscripts submitted to journal.

CMC Scientific advisor for a company focusing on developing precision antibody therapeutics to improve outcomes in patients with hard-to-treat cancer

Leadership responsibilities included:*Cell culture/Upstream, Purification/Downstream and Manufacturing Science and Technology areas*Manufacturing for early stage clinical studies (completed two DS GMP campaigns) internally and at CDMOs

Leadership responsibilities include*Resource and project planning **Contributed to commercial regulatory approvals of Margenza, Margenza PAS, and Zynyx.*BLA, IND and IMPD Regulatory submissions *QbD based development approach*Technology development *Platform development *Preclinical and clinical drug development study support

Drug Product Sciences Function Responsibilities:*Pre-formulation & Formulation development for novel biologic therapeutics (mAbs, DARTs, ADCs)*DP process development and characterization*DP technology transfer to multiple CMOs*Technical oversight of clinical and commercial biologics DP manufacturing *Process Performance Qualification strategy and execution*Process control strategy for DP from early stage to commercial launch*Primary container development including extractable & leachable strategy *Biophysical and molecular characterization of proteins *Particle characterization (sub-micron to visible particles) *Compatibility testing with IV and SC components*Combination product developmentAnalytical Sciences Function Responsibilities:*Analytical method development, qualification and transfer to QC group for in-process, release and stability methods for drug stubstance and drug product*Control strategy development for drug substance and drug product- Development of Chromatography, CE, residual impurity, ELISA, qPCR and excipient quantitation analytical methods* Mass spectrometry methods including peptide map and glycan analyses* Elucidation of Structure using orthogonal characterization methods* Analytical comparability studies for process changes* Reference standard characterization* Toxicology lot release and clinical lead lot stability monitoring* Specification justification for in-process, DS and DP methods*Developability of pipeline molecules

Leadership responsibilities include*Contributed to product development leading to commercial regulatory approvals of multiple biosimilars*Formulation and Drug Product process development/characterization*Combination Product development support*Bioanalytical method development team at Chennai site under broader Analytical Sciences group*Life Cycle Management (LCM) and differentiation programs*CMC strategy planning support for pipeline molecules*Communication across global sites

*Leading drug product process development at two global sites (Lake Forest, US and Chennai, India) under broader DP group*Formulation development for biologics pipeline molecules*Drug product (DP) process development (PD) and characterization (PC) *Biophysical characterization based pre-formulation and developability platforms*Primary container selection/development (vials and PFS) and second sourcing*Extractable/leachable and glass vial delamination mitigation strategies*CMC lead for multiple pipeline molecules and coordination of DP PD efforts at multiple global sites*Building the formulation, DP process development and primary container group at Hospira Biologics Development Center, Chennai, India *Particle Characterization for Drug Product workstreams*Device combination product development for biologics; Liaison with device group*Life cycle management and product differentiation work-streams*Quality by Design (QbD) implementation for formulation and drug product process*DP Platform process development and implementation*Support technology transfer of formulation and process to manufacturing plants*DP PD Resource and program planning

Industrial mentor for graduate students (School of Pharmacy)Also, served as a guest lecturer at Ventura College (Biotechnology series, 2009 & 2010) and University of Colorado Denver (Pharm dev, Graduate course, 2010)

* Liquid and lyophilized protein formulation development* Bio-analytical and biophysical support for Drug Product development of antibody and peptibody molecules* High concentration formulations* Evaluation of different primary containers (esp alternate pre-filled syringes) and devices* Biophysical and particle characterization* Formulation technology development team lead* Instructor for advanced internal training courses on lyophilization/freeze-drying of biopharmaceuticals

Formulation and Analytical Resources group, Process development deptCommercial liquid and lyophilized formulation development for monoclonal antibodies and Fc fusion proteins

Research assistantCollaboration with Amgen, Genentech and multiple other companies working on the following programs:• Characterization of aggregation for GCSF, alpha-synuclein, HSA and IL-1RA protein molecules in different solution conditions• Contract research : Analytical characterization of a pipeline peptide molecule• Contract research : Development of Novel drug delivery vehicle for proteins• Contract research : Formulation development for a MAbTeaching assistantCourses in Medicinal Chemistry, Pharmacy Practice and Integrated Sciences