Keith White Email & Phone Number

Sacramento, Ca, Us

Waltham, Massachusetts, Us

Provide managerial and technical oversight for process technology transfer, validation, scale-up activities, and commercial manufacturing, ensuring a seamless handoff from Process Development to Manufacturing to maintain adequate drug availability for program needs.* Oversee process and analytical data analysis to identify and resolve key challenges throughout the development and manufacturing phases. Leveraging process data, I strategized with Health Authorities through FDA Briefing Book to implement chromatography resin and column bed supports reuse for multiple products at a commercial scale. Defined the Invivyd “platform” process and collaborated with Health Authorities to streamline the validation approach required for EUA and PPQ filings.* Author regulatory sections to support various filings, including BLA, EUA, INDs, IMPDs, and FDA Briefing Books. I also have supported Type B and Type C meetings, Health Authority inspections, plus conduct vendor audits.* Perform risk assessments to identify, mitigate, and resolve potential regulatory and quality risks in manufacturing. Develop strong relationships with external parties, such as CROs, CDMOs, and raw material suppliers, to effectively mitigate raw material risks. During the pandemic, Invivyd partnered with Health and Human Services (HHS) and BARDA to address raw material supply chain gaps. Mitigating supply risks resulting from the BIOSECURE Act by evaluating new manufacturing sites for both drug substance and drug product.* Partner with Supply Chain to manage drug substance and drug product inventory for supply planning, coordinate commercial production scheduling, and align development projects with our CDMOs. Additionally, developed and implemented a strategy for tracking and mitigating cell banking storage risks.

South San Francisco, California, Us

Providing leadership and oversight for technology transfers to Genentech/Roche manufacturing sites to ensure the successful qualification campaigns and licensure for new manufacturing processes, including the crenezumab and gantenerumab processes to 25kL scale. At the onset of the pandemic, I led the accelerated transfer of REGEN-COV from Regeneron to the Roche Vacaville facility to facilitate Emergency Use Authorization (EUA) for COVID-19. Worked closely with Health Authorities to define the approval pathway for emergency use in the US and globally and collaborated with Federal Government in securing funding from BARDA.Acted as interim-group leader for the tech transfer department, with key responsibilities including:* Acting as the single point of contact (SPOC) for the product technical development team and technical review committees. Collaborating with subject matter experts (SMEs) within the site transfer team to facilitate information exchange and clarify operational procedures with SMEs from the sending unit. Monitoring and overseeing technical activities throughout the transfer process to ensure execution aligns with the approved Master Transfer Plan. * Driving the resolution of technical issues throughout the project lifecycle and ensuring timely escalation as necessary.* Ensuring timely completion of tech transfer deliverables, including process validation, translation of process requirements into manufacturing instructions, and reporting process performance metrics. Providing technical content for the CMC sections (e.g., site-specific process validation) of regulatory submissions and supporting PLI inspections for transferred processes.Also represented Vacaville in the Tech Transfer Lead Reduction Time initiative, where we developed smart tools and templates to achieve a 30% reduction in end-to-end tech transfer lead time by 2020. This included the creation of a tech transfer database & knowledge exchange document.

South San Francisco, California, Us

Managed multi-disciplinary groups focused on drug substance (DS) manufacturing, guiding them from late-stage development through large-scale production support. I have experience in hiring and training staff, planning and managing budgets, recognizing and rewarding team members, and providing leadership to ensure that goals are consistently metAdditionally, led and consulted on numerous technology transfers for CHO and E. coli processes, performing due diligence and gap analysis to assess process and equipment compatibility at both internal and external manufacturing sites. Provided technical support during pilot, engineering, development, and qualification runs, facilitating external contract manufacturing technology transfers. My role also included overseeing daily process monitoring, trend analysis, and troubleshooting for large-scale operations, as well as setting up and running small-scale systems to address operational challenges and to develop small-scale models. Additionally, supported regulatory filings by authoring technical sections for CBE-30, PMP, and sBLA, plus assisted with regulatory inspections internally and at CDMO sites.

Emeryville, California, Us

Successfully led projects in cell culture, recovery, and drug product filling, implementing process improvements, investigating equipment issues, validating new equipment, and training manufacturing staff. I also managed three technology transfers from pilot plant scale to clinical scale. * Additionally, directed equipment upgrade projects, including mechanical polishing, electropolishing, and passivation for bioreactors, plus redesigned control skids to enable dual control of two bioreactors running simultaneously.* Implemented cleaning validation for all XOMA’s bioreactors and small equipment pus led the start-up and commissioning of a new upstream manufacturing suite, collaborating with Engineering, Facilities and Quality to transition from installation to qualification runs.* Furthermore, spearheaded initiatives to enhance chromatogram review, downstream process monitoring, and viral filtration, while also supporting daily operations for column chromatography, column packing, buffer preparation, and filling. I was responsible for updating the media fill qualification procedure to meet current industry standards.

Ann Arbor, Mi, Us

Concentrated on the high-throughput synthesis and testing of inorganic catalysts. Using a liquid/powder dispensing robot, I efficiently generated a variety of catalysts. I designed and synthesized these catalysts based on principles of heat and mass transfer, thermodynamics, kinetics, and tested their performance using a multi-port plug flow micro-reactor. Additionally, I designed and installed utility connections for the micro-reactor’s backpressure regulators and pump plus optimized the PID control parameters for the reactor pump and temperature control modules.

Davis, California, Us

Conducted a study of surface and groundwater samples from streams in the Navarro Basin (Mendocino County) as part of a non-point source pollutant loading investigation. The samples were analyzed for concentration using spectrophotometry and ion chromatography. I developed kinetic parameters to model ion transport within the Navarro River and its tributaries. Additionally, I designed and implemented standard protocols for data collection and analysis. Through this work, I gained proficiency in distillation, electrophoresis, chromatography, and various spectroscopic techniques, including IR, NMR, MS, and UV.