After 14 rewarding years at BioMarin and following ROCTAVIAN European commercial approval in August 2022, I decided it was a good time to voluntarily step away from my role as Sr. Manager of MSAT Technology Transfer and Process Validation. I've been using this time as an extended sabbatical, focusing on my health and well-being (by eating, traveling, and reconnecting with the people and things that I love) to recharge and foster future growth for my next opportunity.

Provided effective leadership and direction to a strong team of project engineers, validation engineers, and project managers for both MSAT Technology Transfer and MSAT Process Validation functions, whose responsibilities include leading and managing various drug substance and drug product manufacturing technology transfer and process validation activities such as process and equipment scale-up engineering, process and equipment qualification/validation (including continued process verification), and project management for new product introduction, and providing project-based technical support for early-stage and late-stage manufacturing production operations of all recombinant protein therapies and gene therapies produced at the Novato, CA manufacturing site.Represented the Manufacturing organization on the Chemistry, Manufacturing, and Controls (CMC) Team as the CMC Drug Substance Partner Team Lead for BioMarin’s first ever gene therapy product, ROCTAVIAN. Collaboratively led early-stage and late-stage manufacturing production readiness efforts and supported process performance qualification (PPQ) for ROCTAVIAN, which subsequently contributed to commercial approval of the product. Supported various CMC initiatives throughout multiple CMC development stage gates, including quality target product profile (QTPP) and critical quality attribute (CQA) definition, process parameter characterization and comparability assessment generation, marketing authorization application (MAA) and biologics license application (BLA) regulatory filing authoring, and product lifecycle management following completion of PPQ.Strategically implemented new manufacturing technology transfer global policy and guidance updates to align multi-modal technology transfers between all BioMarin manufacturing sites for clinical-to-clinical, clinical-to-commercial, and commercial-to-commercial manufacturing production scenarios.

Managed multiple high-profile technology transfer projects, including implementation of several early-stage and late-stage clinical manufacturing processes into the Novato, CA clinical manufacturing facility that have successfully progressed into commercially approved products (VOXZOGO, PALYNZIQ, BRINEURA). Closely led interdepartmental sub teams (process sub team, equipment sub team, raw materials sub team, in-process analytical sub team) through manufacturing technology transfer planning and manufacturing production execution under compressed timelines. Effectively utilized standard project management tools such as project charter, communication plan, deliverables tracker, project schedule, and risk register to drive project success.Planned and performed various small-scale and production-scale studies (e.g., range-finding studies, functional testing) in collaboration with Process Development in preparation for manufacturing production. Provided person-in-plant support during production operations. Contributed to various CMC initiatives through manufacturing technology transfer activities in support of product commercialization.Successfully implemented several capital equipment projects (equipment design, procurement, and qualification) totaling over $10M in assets for the Novato, CA clinical manufacturing facility.

Reliably manufactured formulated bulk drug substances for early-stage and late-stage clinical products in an agile cGMP environment. Gained a breadth of hands-on experience with various upstream and downstream bioprocessing unit operations: perfusion, batch, and fed-batch suspension cell cultures / fermentations (mammalian and bacterial) ranging from seed to production (2000 L) scales, and cell separation, recovery, and purification techniques such as depth filtration, tangential flow filtration, homogenization, centrifugation, clarification, and column chromatography. Consistently displayed outstanding troubleshooting and analytical skills to support production on the clinical manufacturing floor.

Established a basic foundation of upstream bioprocessing knowledge, including the theories and applications of bioreactor control strategy (DO control, pH control, etc.).Built, inoculated, and maintained a 100 L pilot-scale bioreactor with the assistance of Process Development staff for the production of pre-clinical material to be used for toxicology studies. Built, inoculated, and maintained a number of 10 L bioreactors with minimal supervision for various range-finding experiments.

Established a basic foundation of downstream bioprocessing knowledge, including the theories and applications of depth filtration, tangential flow filtration, and column chromatography. Learned and performed a number of analytical methods such as gel electrophoresis (SDS PAGE), western blot, Bradford, and RP-HPLC to qualify and quantify protein purity.In October 2009, returned to Process Development in an emergency situation to support Clinical Manufacturing production operations. Ran scale-down satellite chromatography columns and conducted valuable protein analysis on an extremely tight timeline, which directly resulted in the salvaging of a clinical production lot in question.