Head of Drug Product Manufacturing: Aseptic filling, Visual inspection, packaging and assembly of pre-filled syringes and auto-injectors. Site Wide responsibility for Manufacturing Execution System (Pas-X).

Leads bio-pharmaceutical drug substance manufacturing operation areas to remain compliant with regulations, procedures and standards for clinical and launch production. Responsible for ensuring compliance for all Drug Substance production operations in a highly complex environment.-Leads and manages work of group to investigate deviations, manage changes and introduce new products into the facility-Leads and manages work of group creating, maintaining and reviewing Electronic, Paper and Hybrid Batch Records

Leads bio-pharmaceutical drug substance manufacturing operation areas to remain compliant with regulations, procedures and standards for clinical and launch production. Responsible for ensuring compliance for all Drug Substance production operations in a highly complex environment.-Leads and manages work of group to investigate deviations, manage changes and introduce new products into the facility-Leads and manages work of group creating, maintaining and reviewing Electronic, Paper and Hybrid Batch Records

Created new metrics to drive deviation management process improvement. Created and implemented new programs to reduce cycle time for deviation handling. Reduced front-of-process milestones by 20%. SPOC for client deviation and CAPA management. Oversees a team of 6 specialists all partnering with manufacturing and quality to reduce overall deviation rates.

Responsible for managing the activities for upstream manufacturing (Fermentation, Technical Services, and sitewide GMP services, team of 30). Consistently deliver high quality, on-time, in-budget. Subject Matter Expert / Business owner of SAP for manufacturing, product costing, production planning, materials management. Cross Functional team leader of Supply Chain, Finance and IT initiatives. Responsible for DR/CAPA resolution, owner of all GMP documentation. Onboarded new molecule from 3rd party, defined manufacturing process and engineering. Startup of new facility including ISO 5 cleanroom, ISO 13845 certification. Project manager for newly created CMO activities - technical transfer of new molecules into existing facilities. Through process engineering strategies, acquiring capital equipment, personnel and other resources to deliver phase I material to internal and external customers.

Sr. Manager of GMP warehouse operations and Technical Services (reagent and glassware preparation). Directly manage 5 people leaders and project managers (staff of 20) and operate functional budgets for both groups. Current cross functional projects include Glasswasher optimization, Lean Warehousing, Warehouse remediation and consolidation. Project Manager for Grifols SAP integration for Manufacturing (PP &MRP) and warehouse (WM). Multi-national cross functional team to implement Grifols SAP platform in the legacy Novartis business. Combined with Warehouse remediation efforts this will yield 33% reduction in transactions, reduce headcount and lower costs. Provide updates to Head of Division, site heads of quality & operations.Project Manager for the acquisition of Warehouse and raw materials Quality Control operations and facilities from 3rd party. Evaluated potential insourcing and outsourcing of Warehouse and QC operations. Integrated people, technology and facilities and set up systems to ensure long term compliance to GMP requirements. Provide updates to Head of division, site heads of quality and operations.

Directed RIBA Manufacturing operations including reagent formulation, filling, strip coating and packaging. Staff of 16, Reduced production cycle time from 88 days to 35 days. RIBA Products were discontinued in January 2013. Directed shutdown of plant operations while maintaining GMP status and legal compliance. Worked with US legal team in discussions with US Attorneys office, Site Head and Global legal team

Program manager for global earthquake risk mitigation project. Sub projects include technology transfer of filling & freeze drying, packaging and distribution to alternate sites in Germany, Italy and the US. Transfer of Active ingredient (API) to alternate sites and seismic retrofitting of existing Berkeley campus. Authored appropriate regulatory documents and filings. Project manager for operations projects with global impact. Act as liason between development, manufacturing sciences, technical operations and supply chain functions for product lifecycle management projects and for new drug products. Represent the Berkeley site for Make or Buy decisions, contract management and due diligence projects.

Responsible for Bulking/Compounding, Aseptic Filling and Freeze Drying operations. for recombinant biological product, as well as contract and clinical manufacturing of other products. Reduced process deviations by 10% in first year, maintaining 10% year over year error rate reductionReduced scrap 50% through OPEX / Lean manufacturing techniques.Successfully transferred 33% of staff to alternate facility while increasing output at current facility . Improved schedule attainment by 15% in first six months working with Supply Chain and Engineering. Champion for multiple green belt projects resulting in savings of 4 headcount, 40% reduction of work hours. Responsible for $10MM operating budget. Author /Owner of change controls, deviations and other QMS functions. Completed risk profile and user compliance testing of new container closure system (ISO 14971)

Directly supervise management, staff and team of 90 union employees. Responsible for all packaging operations, warehousing operations, SAP operations management and inventory control functions, including Sarbanes-Oxley compliance. . Developed strategic plan for continuation of lean principles in manufacturing. Increased overall inventory accuracy by 6% to 94% in 6 months through directed programsInstituted best in class targets and metrics for warehouse staff. Responsible for $10MM operating budgetPosition eliminated due to consolidation with Filling, Freeze Drying department.

Manage supervisors and unionized staff of 40 in visual inspection and secondary packaging of lyophilized parenterals. Managed 25% annual growth rate of product sales and marketed presentationsQualified new production facilities in California and Kansas including authoring regulatory documents and filings. Developed Lean Manufacturing program: cut cycle time by 75% while reducing headcount by 30%. Reduced process deviations by 35% while increasing volume 20% through standard work Responsible for technical aspects of packaging design. Created validated defect tracking database. Responsible for operating budget in excess of $6MM.

Directly supervise 5 production supervisors and a unionized workforce of 120 employees in a three shift operation. Manage the construction and distribution of over 1200 unique items for diverse customers. Manage "non-standard production" and customer specific requirements including seasonal labeling, and EDI. Reduced changeover frequency by 20% Increased production per labor hour by 21%. . Revised planning model and eliminated graveyard shift.

Responsible for identifying process improvement opportunities, and assembling cross-functional action teams. Calculate Return on Investment and present projects to Senior Management. Act as project manager on approved projects, managing staff and line level employees to achieve project goals. Major projects include Design and install networked thermal printing system (Videojet Dataflex)Implementation of enterprise-wide Time and Attendance system (Kronos WFC)Implementation of new enterprise wide payroll system (ADP)Enterprise wide implementation of Warehouse Management System (Swisslog)Installation of an enterprise wide RF scanner networkRobotic palletizing system with integrated inkjet printing systemDirect responsibility for Multi-Million dollar annual capital budget program. Direct responsibility for $2MM annual utilities budget, and all aspects of energy management.

Provided first and second level support for hardware, software and local area network for desktop users. Implemented system wide E-mail upgrade. Created and delivered training for applications and authored procedures.

Supervise staff of 5-12 in pharmaceutical cGMP environment. Supervise all aspects of BOTOX vial and device production. Schedule and prioritize production tasks. Hire temporary workers as needed. Responsible for all aspects of shipping and receiving, including import and export. Supervise purchase and receipt of inventory, including all packaging components. Developed users manual for medical devices. Increased throughput of production department by 17% in one year. Reduced cost of materials 9% by revising purchasing procedures. Managed 300% increase in packaging configurations.As Facilities Supervisor: Responsible for facilities contracting including communications, remodeling, equipment validation, cleaning, security, maintenance and utilities. Supervised purchase, installation, and validation of walk-in freezer, designed and executed clean room renovation, coordinated build out and reduction of facility. As Network Administrator: Managed all aspects of SAP R/3 rollout for remote site. Won "Award for Excellence" for all aspects of SAP R/3 implementation. Installed new cable plan for LAN/WAN Install, monitor and maintain network and desktop software. Primary contact with corporate office for all computer systems, including CSS / Irma, BPCS / Rumba, and SAP R/3 . Responsible for communications contracting (LAN/WAN/Telephony)

Directed daily operations of a 35 member non-profit traveling musical group. Evaluated performance, social and financial aspects of group; counseled and terminated individual members. Recruited 7% of members for 1993 season.

Analyzed soil and groundwater samples using inorganic and GC methods. Presented improvement opportunities to corporate officers, resulting in corporate adoption of TQM. Revised reagent grade water system, resulting in a 20% cost savings.