Brian Choy

 Developed and utilized robust processes for the identification, evaluation, and management of third party contract manufacturers.  Collaborated with Legal to negotiate a Master Service Agreement (MSA) and Statement of Work with the CMO. Manage supply agreement milestones and deliverables.  Led cross-functional teams in selecting, implementing, and managing manufacturing processes at CMOs and tech transfers for particular products.  Acted as primary contact for all operations and business collaborations ensuring that the overall relationship between Genentech and the CMO is healthy.  Drove continuous improvement of the business relationship including improvement of contracts.  Applied extensive theoretical, technical and cross-functional expertise to address complex operations problems.  Proactively identified risks and create strategies to avoid or minimize their impact.  Collaborated on forecasting, production planning and procurement business process activities and perform required business process operations  Collaborated with External Quality on quality system and compliance activities at partners/CMOs including implementation of an over sight and metrics trending process, and reduction of Compliance Risks.  Negotiated and Implemented transformational changes at CMOs including vial segregation processes, bioburden controls alignment, visual control improvements, and Governance structures.  Served as a technical subject matter expert (SME) in support of department functions and in mentoring junior personnel

 Managed Drug Product Commercial and Non-Commercial Filling operations within the SSF manufacturing site.  Presented and defended manufacturing processes with internal and partner audits, as well as US and foreign regulatory agencies.  Orchestrated a thirty percent increase in production and headcount within a three month period.  Fiduciary responsibilities of two manufacturing cost centers with a combined Cost of Production of~$140M Annualized.  Managed a five fill line process with approx. 100 employees in the Organization to produce over 10M vials per year.  Business Process Manager (BPM) for the Drug Product Class A and SAP implementation teams.  Assembled the departments cross functional Area Leadership Team (Governance Model Implementation) to drive the “End to End” business.  Sponsorship of the Commercial Fill recipe rebuild and VSM project, TPM, OEE and other CPI initiatives.  Demonstrated resilience and cross functional leadership to overcome serious production down time events.

 Managed small scale mammalian cell culture, bacterial fermentation and cell banking functions, pilot plant and plant support operations within the SSF manufacturing site.  Capital Projects Core Team Leader. Championed, facilitated and financially managed facility upgrades projects.  Sponsored an international training program with the Singapore Economic Development Board.  Improved efficiencies through change management and restructuring initiatives.  Responsible for managing a $12M annual cost center budget.