• Plan and oversee day-to-day GMP activities of the quality function.• Ensure appropriate quality oversight of external Vendors.• Active member of GMP Vendor meetings.• Review and approve Vendor GMP documentation.• Review and approve Vendor and Kura GMP Quality Events.• Review and approve executed batch records for associated Regulatory Standard Materials, Intermediates, and Drug Substance Kura’s program and determine final batch disposition.• Support adherence to Vendor Quality Agreements.• Generate quality metrics and compile data for Quality System Reviews.• Participate in Kura GMP sub-teams as the Quality Representative.• Evaluate GMP activities for continuous improvement opportunities to the Kura Quality System.• Provide QA review of CMC related sections of regulatory filings.• Coordinate and manage compliance related activities in preparation for Health Authority inspections and support interactions during Health Authority inspections.

- Responsible for establishing strategy, policies, and procedures to meet quality improvementefforts to meet internal and external customer needs and expectations.- Manage a technical team of highly trained quality managers and specialists to implementquality systems and activities.- Oversee quality management systems in accordance with federal, state, and internationalregulations and standards to ensure the continuing suitability, adequacy, and effectiveness.- Coordinate interdepartmental activities both internally and externally to ensure suppliers,vendors, and internal functions meet quality standards.- Lead and guide investigations to resolve quality issues to ensure robust CTM supply for clinicalprograms.   - Evaluate key business and scientific challenges to create complex initiatives having cross-functional impact.- Provide quality leadership for clinical stage programs at all phases of development for API anddrug product work-streams.- Configure and use Veeva Vault platforms to track deviations, change controls, CAPAs, andOOS/ OOT quality events.- Provide quality leadership for clinical stage programs at all phases of development.- Establish and review Quality Agreements for API and Drug Product manufacturing.- Conduct contractor service provider audits.

• Manage Quality Agreements with respect to supply contracts for commercial manufacturing vendors used for active pharmaceutical ingredients (API) and finished drug products• Quality oversight of manufacturing facilities for Commercial, Phase III, and early phase development programs• Support technology transfer and process validation of API and finished drug product manufacturing processes. • Serve as subject matter expert (SME) for CSP facility audits. Supervise development activities, and serve as “man in plant” for process development group• Authoring and review of CMC sections for sNDA and IND submissions o Wrote experimental design facilitating the submission of Pimavanserin sNDA for second generation manufacturing process of Pimavanserin tartrate. sNDA approval enabled the release of 2 million dollars of commercial API.o Author and review CMC sections as lead QA representative and subject matter expert for ACP-201 Pimavanserin follow-on.o Lead QA representative and SME for ACP-204 Pimavanserin follow-on Phase 1 clinical candidate for IND submissiono Lead QA representative and SME for ACP-298. Potential adjunctive therapy for use in CNS disorders.• Review and approve batch documentation, change controls, deviations, and related corrective and preventative actions (CAPA). Review and assist contract service providers with external deviations, OOS/OOT material, and complaint investigations• Implementation, management and improvement of ACADIA GMP quality management systems, processes, and protocols.• Material review board (MRB) investigations and disposition• Responsible for batch record review and disposition of drug substance intended for clinical or commercial use• Compile metrics to facilitate management review of annual product review (APR) and product quality review activities• Manage translation services of various source languages for quality assurance, manufacturing, analytical development, and patient facing documentation.

• Senior process chemist developing processes used to manufacture toxicology and clinical material used in indications for obesity, sleep, auto-immune disease, and pain management. • Managed GMP manufacturing of in-house pilot plant • Technical liaison between quality assurance and manufacturing• Created and managed risk assessments for manufacturing and GMP compliance• Management of manufacturing deviations and related CAPA• Internal and external facility audits• Utilized DOE (design of experiments) to find optimal parameters to define operating parameters and failure ranges for chemical processes and manufacturing parameters• Managed budget, installation, and maintenance of analytical capabilities used in the process development group• Team member that developed and validated the commercial manufacturing process used to manufacture Arena compound APD356 (Lorcaserin)o Marketed under the trade name Belviq used in the long term treatment of clinically obese patientso Optimization of manufacturing parameters used in process validation runso Developed and transferred chemical processes used for primary and secondary commercial supply of regulatory starting materials and API.• Project manager for insomnia drug candidate APD125o Managed team of 10 chemists and engineers through proof of concept development runs.o Demonstrated robust manufacturing process at 400 liter scale for Phase III technology transfero Developed and demonstrated complex polymorph control through experimental design (DOE) and data rich experimentation.o Managed reagent sourcing for GMP campaigns through suppliers in the United States, Europe, and China• Project manager for AR306912, drug candidate for Insomniao Effectively managed 4 chemists to manufacture Phase I supply under cGMP o Developed and demonstrated complete synthetic route used to synthesize multi kilo supplies in under 6 monthso Transferred technology and sourced starting materials from Ex-US CMO (CN)

• Process development of Phase I/II drug candidates • Project management, reagent sourcing, and time line generation• Development of GMP protocols, process directives, and standard operating procedures• Authoring of technology transfer reports for API manufacturing• Deviation management and corrective action implementation

• Process research and development of commodity scale bio-polymer fermentation processes• Development, troubleshooting, optimization, and implementation of manufacturing improvements used in biopolymer manufacturing and downstream processing• Technology transfer of manufacturing improvements to commercial site

• Process research and development for nutritional supplements• Development of down stream processing of fermented biomass • Development of commercial hydrogenation processes • Manufacturing equipment evaluation and selection• Technology transfer and supervision of contract manufacturing facilities• Writing of GMP protocols, process directives, and standard operating procedures• Batch record authoring, execution, and auditing• Designed, maintained, and operated in house explosion proof pilot facility• Standard chemical analysis by GC, HPLC, NMR, and DSC.