Provide clients with strategic Technical Operations and Regulatory CMC leadership to develop and commercialize novel therapeutics.• Lead teams authoring Module 2 and 3 sections for INDs, BLAs, MAAs, and post-approval variations, including additional DS, DP sites, and additional presentations for biologics and combination products mAbs, antibody-drug conjugates, biologics, autologous cell therapies.• Direct strategic sourcing initiatives to identify API, DS, and Drug Product manufacturing sites review contracts, cell line licensing, and quality agreements, and initiate tech transfer or gene-to-clinic development.• Provide key point of contact interface between clients and CDMOs executing gene-to-clinic programs.• Perform CMC, Reg CMC Due-Diligence evaluating development, IND, and late-stage clinical assets.• Develop CMC Questions, represent client CMC Teams at FDA Type C Meetings, and solicit scientific Advice from other health authorities.• Determine Strategy, and manage responses to CMC questions from health agencies in North America, Europe, and the rest of the world, including complete response remediation and strategies to remove clinical hold on first-in-human trials• Redact/Revise dossiers to address regional requirements in ROW markets, including China, Brazil, GCC, etc.• Support submissions through MAA approvals in EU, China, Russia, Taiwan, Brazil, Saudi Arabia, etc.• Assess manufacturing facilities and tech transfer plans for clinical stage cell therapy products, and validation documents for a lentiviral vector process for CAR-T therapy.• Manage external development and manufacturing for biologics (CHO, E. coli, aspergillus) and small molecules.• Lead CMC tech Operations Activities for accelerated development of a novel-COVID related antibody treatment• Person-in-Plant services during tech transfer, PPQ, engineering, and clinical manufacturing.• Provide engineering procurement support for process-related capital expenses.

Provide advice regarding creation of Center for Biopharmaceutical Education and Training (CBET)

Molecular steward for three APIs. Represented the project to high-level internal cross-functional teams and served as the primary liaison to a European CMO. • Co-lead joint technical teams to define, prioritize, and manage a technical project agenda with a CMO addressing FDA feedback, continuous process improvement, corrective actions, and raw material supply.• Developed timelines and project plans with Project Leaders to ensure successful clinical supply, regulatory support, and accurate financial forecasts. Issued regular updates to management on risks and objectives.• Person in Plant operations and technical support during business-critical production activities.• Transitioned CMO relationship through acquisition and facilitated cross-functional integration of an acquired technology into Lilly quality systems and alignment with internal guidance. • Developed a program to monitor and maintain process knowledge generated by external manufacturers. • Wrote and reviewed CMC sections of INDs, campaign summary reports, deviations, and annual product reviews.• Directly managed more than $1MM in external pharmaceutical development studies.• Prepared and submitted spending projections as part of budgeting activities and rolling financial forecasts.

Responsible for engineering and technical writing project management activities related to commercial production at a European CMO, long-term process improvements, and pre-approval inspection readiness.• Established and managed CMC operations technical agenda and PAI prep at an OUS CMO.• Mentored a CMO to improve compliance and process consistency, increasing batch success rates and dramatically reducing deviation frequency and severity. • Prepared and supported a CMO through their site’s first successful pre-approval inspection.

Responsible for engineering and technical writing project management activities related to commercial production at a European CMO, long-term process improvements, and pre-approval inspection readiness.• Applied quality by design principles to re-assess three in-licensed API processes' validation and development history. Collected scattered process knowledge and reduced it to a transferable narrative.• Wrote NDA sections regarding drug substance process development history and critical process controls.• Developed a corrective and preventative action plan and technical agenda for a CMO to provide continuous process improvement and pre-approval inspection readiness.

Facilitated tech transfer and commercialization of industrial biotechnology production of carotenoids and itaconic acid from fungal fermentations. Designed and executed proof of concept pilot scale studies.

Responsible for re-developing processes to fit CMO equipment, successful tech transfer and validation.• Transferred drug substance manufacturing processes to a European CMO by overseeing critical equipment qualification, and startup, as well as process engineering, troubleshooting and validation.• Wrote and reviewed documentation including development SOPs, batch records and reports, commercial master validation plans, membrane lifetime study protocols, and regulatory fillings (IND, NDA).• Captured process knowledge through the aggregation and analysis of monitoring data from multiple CMOs and development labs.• Provided technical assessments of change controls, deviations and CAPAs affecting protein purification steps. • Created a technology development project plan and identified scaling techniques for a unique centrifuge application in crystallized enzyme recovery. • Used DOE techniques to map the process design space.

• Provided internal and external customers applications R&D support by evaluating existing filtration products, developing new products, and technologies using both model systems and customer antibody feeds.• Developed a new scale-down tool for protein purification processes allowing TFF process development at smaller scales without sacrificing reliable linear scale-up. • Evaluated device design parameters, molding and heat sealing details on the scalability, cleanability, and comparability of a new family of tangential flow filtration products.• Applied training in project management and DOE techniques to plan and execute new product development, product comparability, and continuous process improvement testing within broader project timelines.• Authored protocols, and supervised validation and characterization testing to support an internal manufacturing site transfer.• Protein purification experience included ultrafiltration, chromatography, virus, sterile and depth filtration.

As an intern, I communicated with managers, engineers and customer service reps to research and write installation, user's guides, and application notes for current and developing supply chain management database products.