Raleigh-Durham-Chapel Hill Area
Burak has led and managed projects in Manufacturing, Process Operations, Supply Chain, Engineering, Quality, and Regulatory Compliance roles for products in various presentations including medical devices, combination products, and solid oral dosage forms. Burak has doctoral experience in microfluidics, including fabrication of composite materials and devices. At RedHill, Burak led Technology Transfer of production processes into commercial manufacturing at contract manufacturing and packaging organizations (CMOs & CPOs) and managed ongoing commercial manufacturing including process monitoring, troubleshooting, and continuous process verification (CPV). Burak also managed and supported cross-functional teams for projects relative to API and drug product process improvements, scale-ups, and similar development activities at CMOs. Additionally, Burak managed Supply Chain for all the commercial products. While at Kymanox, Burak led and supported projects including process design, facility design and build, equipment procurement, packaging design and development for commercialization of pharmaceutical products, managed and created design history files for combination products, performed technology transfer and compliance gap assessments, and developed manufacturing control strategy procedures for medical device diagnostics and biopharmaceutical companies. Among the facility design and commercialization activities for new-generation drugs and medical devices, he also performed risk management analyses and optimization analyses such as throughput, equipment scheduling, and equipment layout. During his doctoral studies at North Carolina State University, Burak worked as a research and teaching assistant and obtained his PhD with the dissertation titled “Development and Characterization of Multifunctional Microfluidic Materials”. Burak’s doctoral work focused on the development of smart, soft composite materials with embedded microfluidic networks, which enable the materials to possess physical properties that can be changed on demand. To complement and verify the experimental work, he also performed simulations. During his doctoral study, Burak also gained experience in the printing industry. He worked with interdisciplinary teams to synthesize microparticles via microfluidic devices and to investigate microfluidic flow systems of water-in-oil-in-water emulsions by both experimentation and modeling.
• Including CMO selections and evaluation, managed technology transfer of a drug product, drug substance, and their registered starting materials after a product acquisition, starting from plan development through FDA submissions/approvals. • Provided support for routine manufacturing (Deviations, Changes, CAPAs) with CMOs and CPOs. • Collaborated with Quality Assurance, Quality Control, Regulatory, Legal, and R&D for commercial readiness of development products and supply continuity of commercial products. • Performed supplier evaluations, selections, and negotiated all associated Supply Agreements through to execution. • Developed new packaging design for an existing commercial product. • Managed Supply Chain for all commercial products, organized S&OP meetings, and maintained forecasts and POs. • Produced technical documentation (e.g., detailed product and process description) for existing commercial products and initiated continuous process verification plans. • Managed artwork design/revisions and supported ongoing maintenance.
• Led Manufacturing Science and Technology Group and provided SME services to Quality, Compliance, Packaging, and PMO Groups for numerous small and large pharmaceutical and biotechnology companies. • Managed operational readiness assessment and implementation projects for a new, ~500-people GMP facility designed to manufacture combination products. • Managed, built, and remediated Design History Files for combination products, led risk management analyses, and design verification activities. • Performed QA assessments for designing commercial facilities for gene therapy products. • Led process design group during design and build phases of a multi-purpose pharmaceutical facility (capable of manufacturing implants, tablets, and pre-filled syringes) constructed to handle DEA materials. • Managed secondary packaging activities, including artwork design, revision, and serialization activities, to commercialize and transfer combination products. • Performed internal and Supplier Quality Audits. • Performed technology transfer gap assessments for a large-scale medical device diagnostics manufacturer and created corresponding output procedures. • Managed and supported conceptual designs for facilities manufacturing new-generation drugs and medical devices by performing analyses such as feasibility, process design, throughput, equipment scheduling, equipment layout, and risk management. • Supported and managed completion of a manufacturing line capacity analysis, stabilization, and enhancement project for a large-scale medical device diagnostics manufacturer. • Authored Standard Operating Procedures and Validation Protocols and executed Validation Protocols. • Created detailed product and process descriptions and manufacturing control strategy procedures and evaluated and revised manufacturing process characterization matrices that included assessment of critical process parameters. • Supported authorship and review of a BLA for a new biologic-device combination product.
As a PhD student I have been working in the field of microfluidics at NCSU since 2008, where my goal has been to develop novel materials by incorporating micro-scale channels with fluids which enable enhanced functionalities.
• Synthesized multiphase microparticles and designed microfluidic systems for the fabrication and analysis • Initiated modeling for the multiphase fluid flow in microfluidic channels