David Blasingame Email & Phone Number

Hayward, California, Us

South San Francisco, Ca, Us

South San Francisco, Ca, Us

Harleysville, Pa, Us

Los Angeles, Ca, Us

• Managed drug substance manufacturing tech transfer and commercial launch activities for Neratinib Maleate• Lead the operational activities at Puma’s drug substance CMOs• Serve as drug substance subject matter expert on cross-functional CMC teams• Authored and reviewed drug substance CMC sections of NDA and MAA

San Rafael, Ca, Us

• Managed drug product manufacturing tech transfer and commercial launch activities for the Kuvan Oral Powder and the Cerliponase Alfa products• Identified, evaluated, selected, and negotiated a contract with a CMO for drug product manufacturing for 1 large molecule and 1 small molecule product• Developed CMO selection plan by defining contract manufacturing requirements and evaluation criteria for 2 programs• Developed, designed, and executed strategies to optimize manufacturing, increase yields and robustness, which included a 5x scale-up while meeting drug product GMP delivery targets• Reviewed and negotiated CDAs, MSAs, SOWs, and quality technical agreements• Developed RFPs, and solicited and evaluated proposals for 3 programs• Prepared CMC sections for CTAs, INDs, and MAAs• Managed 3 direct reports

San Rafael, Ca, Us

• Person-in-plant and point of contact responsibilities for 5 projects at 5 different CMOs, actively managing the on-going relationships to ensure BioMarin’s expectations for product quality, cGMP compliance, costs, and production targets were clearly understood, well-documented and consistently met while meeting GMP production targets• Managed tech transfer activities for 1 new Phase I and 1 Phase III clinical drug product manufacturing projects• Served as site technical lead, responsible for technical review of process data and management of proposed facility, equipment, system, or process changes• Provided the single point of accountability for identifying and managing timely resolution of business, operational, and quality issues• Coordinated and supported BioMarin’s audits and regulatory inspections at the CMO sites• Authored drug product CMC sections of regulatory submissions for 4 clinical and 1 commercial programs• Coordinated cross-enterprise forecasting, capacity planning, scheduling, and inventory management processes• Managed 2 direct reports

San Rafael, Ca, Us

• Managed all aspects of high-value biologic drug product contract manufacturing across 8 projects at 6 different CMO sites to ensure timely delivery of product that meets cGMP and BioMarin standards in order to supply clinical and commercial needs• Managed and interfaced with CMC team leaders, internal CMFG, QA, production planners, QC, logistics, and external CMOs to ensure uninterrupted drug product supply for projects in phase I through commercial• Participated as a CMC drug product manufacturing representative on BMN111, BMN165, BMN701, Aldurazyme, Naglazyme, and BMN190 project teams• Managed manufacturing operations with preparation and review of batch records, deviations, QA investigations, SOPs, validation protocols and reports, and change control• Managed and executed all shipments of FBDS and DP of Aldurazyme, Naglazyme, BMN165, BMN111, BMN701, BMN190, and Vimizim projects with no delayed shipments or interruption to drug supply including the evaluation, identification, and implementation of shipping solutions to meet clinical and commercial needs• Performed all transactions in Oracle on time to accurately reflect inventory and financial impact• Interfaced and managed AP to ensure timely payments of invoices to CMOs• Implemented Secure Portal as a communication tool and central database for internal and external users• Managed 1 direct report

Foster City, Ca, Us

• Responsible for person in plant and single point of contact activities for CMO API manufacturing across a global supply chain that produced > 250 MT annually and ensured that API GMP delivery targets were met• Managed manufacturing operations, which included monitoring vendor performance, issue resolution, scheduling, logistics, batch record and deviation review, and change control management to ensure cGMP compliant manufacturing within CMC regulatory filings and Gilead standards• Designed and executed strategies to optimize manufacturing, increase process yields and robustness, identify and qualify raw material/intermediate suppliers and reduce costs while ensuring continued compliant API production. This included reducing the API cost by 25% over 2 years, implementing a 25% scale up of the API manufacturing process, implementing a 35% scale up of a final intermediate process, and implementing a new process that converted failing API to API that met all specifications • Developed and lead cross-functional teams to resolve manufacturing issues• Developed and reported accurate product availability and effective performance metrics, including process cost estimates.

Foster City, Ca, Us

• Designed and executed strategies to alternative routes for the preparation of advanced intermediates for the lead HCV project which included cross metatheses, hydrogenation reactions and macrolactamization reactions.• Supported the development of a new route for the preparation of advanced intermediates for the lead HCV project on multi-kilo scale to produce clinical API.• Investigated and optimized the syntheses of advanced intermediates towards the synthesis of Elvitegravir, and prepared multi-kilogram quantities of those intermediates to support a pilot plant toxicology GLP campaign.• Provided support and the technology transfer for the preparation of advanced intermediates towards the synthesis of Elvitegravir to a contract manufacturer.• Prepared all required supporting process documentation which included development reports, research reports, and department meeting presentations.• Provided regular timely updates to management on development activities, project team meetings, status changes, contractor issues, and outsourcing issues.• Investigated and optimized procedures for the construction of intermediates in a multi-step synthesis of biologically active small molecules for Hepatitis C and HIV.• Supported production of lead candidates for toxicology batch (multi-kilogram) in pilot plant.• Performed experiments that supported research activities for process scale up and development from gram to multi-kilo processes.• Operated scientific, kilo lab, and pilot plant equipment within cGMP guidelines to produce clinical API’s.• GLP and GMP batch record preparation.• Analyzed data using modern synthetic methods (1H NMR, 19F NMR, 31P NMR, HPLC, TLC, LCMS).• Purified compounds via column chromatography and crystallizations.

• Performed elemental analysis of soil, plant, and miscellaneous samples using atomic Spectroscopy.

• Synthesized substituted isoxazoles via a 1,3 dipolar cycloaddition of various oximes.• Characterized compounds using NMR and TLC.• Purified compounds via column chromatography.

• Researched and developed substituted pyrimidinofurans that were biologically active against Tumors.• Characterized compounds via NMR, LCMS, GC-MS, and TLC.• Used an Emrys Optimizer for microwave-assisted organic synthesis.

• Synthesized heterocyclic intermediates.• Purified compounds using a chromatatron.

• As part of a small team, participated in the production of a solid-phase library using in-house robotics systems.• Worked with automated liquid handling systems (Gilson 215 and Hydra 96).• Carried out literature and database searches.• Prepared written reports and presented at group meetings.• Synthesized and isolated complex organic compounds.

Mba

B.S Chemistry And B.S. Biotechnology