Shoolin Management Company (SMC) is a Biopharmaceutical CMC Consulting Company that advises on CMC development, strategy and innovation (digital transformation, AI value proposition, new ways of working, advanced process technologies)Enabling biopharmaceutical companies with CMC projects - CDMO selection and management, CMC strategy, comparability strategy, regulatory dossier preparation and solving complex technical issuesClients include biotech companies, IP attorneys and health authorities

Built and led the CMC Tech Ops organization (process development and manufacturing). Created data management and data analytics foundation for CMC data feedback into the AI model.Led the first Generate-AI designed monoclonal antibody drugs from candidate selection through accelerated process development and manufacturing at CDMO, and IND package including regulatory interactions. Led Generate's response to the FDA discussion paper on "AI in Drug Manufacturing."

Core member leading CMC digital transformation across Sanofi globally within CMC development, clinical manufacturing and MSAT laboratories. Modality-agnostic - biologics, small molecules, vaccines and consumer healthcare. Led the first successful digitization of CMC laboratories as the blueprint for subsequent deployments.Led the first strategic roadmap for implementing automation technologies in the global MSAT laboratories with the vision of lab-of-the-futureImplemented new ways of working - Material Science team and risk-based cleaning validation - for speed and efficiency of drug development with successful application to four commercial drugs

Global strategy, operations and innovation lead for Global R&D Quality Assurance across all NIBR sites to support research, preclinical and early-stage clinical studies. Drove innovation strategy for the global NIBR Quality team - established partnerships with the therapeutic areas and quality risk identification for novel therapies including digital therapeutics.

Led the global team for Quality oversight of the External Service Providers for GLP and GCP Lab services. Introduced risk-based and continuous monitoring concepts to establish state-of-the-art oversight program.

As the interface between development and manufacturing, streamlined and facilitated end-to-end CMC operations for all portfolio programs through strategic planning and cross-functional team leadership. Included tech transfer, scale-up, manufacturing process improvements, facility-of-the-future design, new technology introductions and manufacturing deviations. Contributed to four drug launches, post-launch support to five drugs and technical support for the early-stage portfolio of > 20 molecules.Built the comparability program jointly with Sanofi as the alliance partner and applied to multiple late-stage clinical and commercial programs. Authored and reviewed regulatory documents and participated in FDA meetings.

10-year strategic plan for clinical manufacturing at a Fortune 500 pharmaceutical company to reduce development costs by $20M and enhance scalability of fast-growing drug pipeline.Formulated strategy of proprietary portable biologics manufacturing system for start-up biotechnology company based on client’s in-house expertise, regulatory requirements and target market.Strategic analysis for a leading Indian biosimilar company to identify ex-India location for expanding the R&D footprint.

Led formulation development of novel RSV viral vaccine from conception through pre-clinical.Global operational team co-lead for development and preclinical advancement of a novel vaccine adjuvant technology.Managed external research collaborations (Universities, FDA and NIH). Expertise in alum, emulsion and polymer particle based adjuvants.

Led multidisciplinary team including senior management (VP and Directors) to increase productivity of the manufacturing process of commercial drug, Orencia by 50 percent.Led process optimization (e.g., new manufacturing harvest process for a Phase 3 drug to increase yield by 10%), cell bank qualification and small-scale qualification studies for late-stage biologics.