Bengaluru, Karnataka, India
Biopharmaceutical leader with 15 years of experience in process development, MSAT, and global regulatory support across biosimilars and novel biologics. I specialize in translating complex scientific development into robust, regulatory-compliant manufacturing processes—driving programs from early development through commercialization. My expertise spans CMC strategy, QbD-driven process characterization, technology transfer, and lifecycle management, with proven success in global submissions. I have contributed to multiple regulatory approvals, including EMA and USFDA, through strong ownership of drug substance CMC modules, regulatory query responses, and audit readiness. Currently leading Process Development and MSAT functions, I focus on building data-driven, scalable, and compliant processes while mentoring high-performing scientific teams and enabling cross-functional alignment across R&D, manufacturing, and quality. Key strengths include: • Global Regulatory Submissions support (IND, BLA, MAA – CMC Modules) • QbD, DOE, FMEA, Design Space & Control Strategy Development • Tech Transfer & Scale-Up (Ambr → 2000L Manufacturing) • Biosimilars & Novel mAbs (Mono/Bi/Tri-specific) • Process Validation & Lifecycle Management (CPV, LCM) • Use of business analytics for data interpretation, model generation and dashboard creation I am passionate about enabling high-quality biologics to reach global markets through scientific rigor, innovation, data analytics and regulatory excellence.
Leading end-to-end biologics development programs integrating process development, MSAT, and CMC strategy Driving data-driven bioprocess development using statistical modeling, and digitalization initiatives Designing and implementing QbD frameworks (DOE, FMEA, Design Space, Control Strategy) Leading technology transfer and scale-up strategies for complex biologics (mAbs, bispecifics) Overseeing process validation (PV), CPV, and lifecycle management Supporting regulatory filings through CMC documentation and technical strategy Managing cross-functional stakeholders, external partners, and client communications
Led upstream cell culture function for development and GMP manufacturing of biosimilar and novel monoclonal antibodies, aligning execution with organizational and portfolio objectives Directed establishment of development and GMP infrastructure, enabling seamless transition from early development to IND/Phase I clinical manufacturing Designed strategies for process development and robust technology transfer to ensure scalable, compliant, and efficient manufacturing operations Spearheaded evaluation and implementation of advanced bioprocessing technologies (e.g., intensified and perfusion-based platforms) to enhance productivity and accelerate development timelines Championed digital transformation initiatives through integration of automation and data systems across functions, improving operational efficiency and decision-making Built and mentored high-performing, cross-functional teams, fostering a culture of technical excellence, innovation, and continuous improvement
Led upstream process development for mammalian cell culture programs, integrating development with manufacturing (MSAT) to ensure robust, scalable, and cGMP-compliant processes Directed process characterization and lifecycle management strategies using QbD frameworks, including definition of CPV limits and control strategies aligned with regulatory expectations Enabled data-driven decision-making through advanced statistical analysis (e.g., Cpk, modeling), establishing acceptance criteria and enhancing process monitoring frameworks Designed and executed early-stage development strategies for complex biologics (including bispecific mAbs), leveraging fed-batch and advanced perfusion platforms (N-1, intensified perfusion) Played a key role in global regulatory strategy by authoring and reviewing scientific advice documents, BLA drug substance modules, and health authority query responses Collaborated with global CDMOs and partners (e.g., Equillium, Catalent, WuXi) to align development strategies with regulatory and commercial objectives Contributed to enterprise-wide innovation initiatives as part of the Center of Excellence (CoE), driving implementation of platform technologies and standardized development approaches Facilitated cross-functional alignment across upstream, downstream, formulation, and quality teams to accelerate molecule development and improve execution efficiency Led and mentored scientific teams, strengthening technical capabilities and fostering a culture of continuous improvement and collaboration
Led end-to-end development of mammalian biologics programs, owning strategy and execution from clone development through drug product in alignment with portfolio and business objectives Directed cross-functional program delivery, collaborating closely with R&D, manufacturing, quality, and regulatory teams to ensure timely and high-quality outcomes Built and led high-performing teams of process scientists, driving execution excellence, capability development, and a culture of scientific rigor and accountability Defined development strategies, experimental design, and execution roadmaps, ensuring alignment with program timelines, regulatory expectations, and commercial goals Oversaw process development across scales (Ambr systems to 2000L manufacturing), enabling successful scale-up, technology transfer, and commercialization readiness Established and validated scale-down models and led process characterization using QbD and DOE approaches to define design space and control strategies Acted as Subject Matter Expert (SME) for upstream processes, contributing to regulatory submissions (IND/BLA/MAA), dossier authoring, and health authority query responses Supported manufacturing through investigation of process deviations, implementation of CAPAs, and continuous process verification (CPV), ensuring cGMP compliance Played a key role in lifecycle management, driving process improvements, productivity enhancements, and robustness across commercial programs Led cell bank strategy and characterization activities, supporting regulatory filings and ensuring alignment with global standards Strengthened cross-functional collaboration and stakeholder engagement, enabling effective decision-making and seamless program execution
Led upstream process development across microbial and mammalian platforms, driving end-to-end strategy from early development through scale-up, technology transfer, and commercialization readiness Directed successful scale-up of bioprocesses up to 2000L for clinical and commercial manufacturing, ensuring alignment with regulatory and business objectives Established and qualified robust scale-down models to enable process comparability, risk mitigation, and lifecycle management Designed and executed comprehensive process characterization strategies using QbD principles, integrating FMEA-based risk assessments to identify critical process parameters (CPPs) impacting product quality (CQAs) Led multi-factorial DOE studies to evaluate process parameters and materials, enabling development of statistically sound design spaces and control strategies Leveraged advanced statistical tools (JMP, MODDE) to drive data-driven decision-making, establish proven acceptable ranges (PAR), and ensure process consistency across scales Oversaw critical studies including hold time, parameter evaluation, and process robustness, ensuring manufacturing feasibility and regulatory compliance Played a key role in defining control strategies and supporting regulatory submissions through scientifically sound documentation and data interpretation
• Led Clone Screening Initiatives: Successfully identified high-yield recombinant protein producers through extensive screening of multiple clones, significantly boosting production efficiency. • Process Development & Optimization: Pioneered the development of upstream processes to establish scalable, soluble recombinant protein expression, ensuring robust performance across various production scales. • Tech Transfer & Scale-Up: Managed the seamless scale-up and technology transfer of processes to commercial manufacturing, ensuring compliance with cGMP standards and minimizing operational risks. • Impurity Investigation & Resolution: Conducted in-depth investigations into mis-incorporation and truncation-related impurities, pinpointing root causes and implementing corrective actions to improve product quality. • Media Development: Innovated in-house media formulations, eliminating the need for hydrolysates and complex components, which reduced costs and streamlined production processes. • Cross-Functional Project Coordination: Acted as a key project coordinator, effectively collaborating with cross-functional teams to meet project goals and timelines, ensuring successful project delivery.
• Assessment of various technical reports of committees intended for modernization and development of Scientific Organizations and their activities viz. establishment of molecular biology laboratory, DNA barcoding of species, establishment of training institute for taxonomy, analysis of phylogeny of species and digitization of collected species • Scientific evaluation of the reports on ongoing projects submitted by different Scientific Organizations, Departments and Universities to promote research in different area of environment and its management • Scrutinization and examination of research proposals in terms of various scientific/technical parameters for financial sanction of the proposal for strengthening different Institutions • Analysis of various scientific activities and their factual proclamation provided by Organizations