Gary Kessler Email & Phone Number

San Francisco Bay Area

South San Francisco, California

Basel Area, Switzerland

Basel Area, Switzerland

Basel Area, Switzerland

South San Francisco, Ca

Quality Assurance (QA) Site Manager/Technical Manager within Genentech's Contract Manufacturing Organization (CMO). Liaison between Genentech and its small molecule solid dosage contract manufacturers for all QA related matters.* Implemented quality metrics for solid dosage contract manufacturing unit to ensure measured performance tracking and data driven decision making.* Negotiated and established quality agreements between contract manufacturers and Genentech.* Lead cross functional/cross company team to perform in-depth gap analysis of Genentech's contractor quality requirements as they related to solid dosage contract manufacturers.

Sacramento, California

• Lead a team of four production supervisors and 140 operators through daily production activities across two shifts to achieve daily output and quality goals.• Reduced overtime allocation by 355% resulting in a month-to-month cost avoidance of $26,000.• Designed and implemented grass roots recognition program aimed at recognizing high performing individuals in the areas of quality, teamwork, safety, company values, and attendance.• Lead all department operations resulting in a 20% reduction in product costs.• Implemented production output tracking system resulting in more accurate resource allocation and short term production planning.• Lead department to meet or exceed, for the first time, 100% of all performance metrics.

Sacramento, California

• Achieved 100% operational flexibility for all manufacturing operations within 90 days for a newly formed team of 28 direct reports through cross training and performance management.• Reduced duration of line sign-offs by 90 minutes through the implementation of resource deployment boards.• Reduced cost per unit by approximately 25% by consistently attaining production yields above financial standard.• Conducted Material Usage Variance financial analysis for all products resulting in identification of approximately $350,000 in monthly material waste. • Lead annual plant shutdown activities for all manufacturing operations resulting in a flawless execution of shutdown projects and an on-schedule start-up of critical processes. • Developed performance metrics for upstream operations resulting in identification and remediation of 24 hour wait times for intermediate products.

One of 45 people worldwide selected to participate in Johnson & Johnson’s renowned leadership development program. Gained experience in the consumer products, medical devices, and pharmaceuticals industries. Professional roles included engineering, operations planning, and quality compliance.

• Reduced number of outstanding product quality investigations by 91%.• Lead qualification activities for the Product Quality Management System (PQMS) upgrade while laying the foundation for system’s global rollout.• Developed over 100 test scripts for the PQMS upgrade leading to a successful system qualification. • Lead FDA audit logbook activities during an audit resulting in each FDA request being fulfilled when required while maintaining accurate audit records.

• Promoted to Plant Production Scheduler in within 3 months of hire.• Institutionalized multi-site change management process resulting in a 92% reduction in Line Item Fill Rate (LIFR) misses using Six Sigma methodologies.• Analyzed consumer demand data for 25 product codes and established production schedules for all products (83 product codes) to successfully meet customer demand.• Successfully planned and scheduled all product codes resulting in zero backorder and or LIFR misses.• Eliminated $16 million in excess inventory through accurate planning, partnering with business units, and maintaining on-schedule supplier shipments.• Lead “Best Practices” initiative for all planning functions resulting in greater uniformity of planning practices across 5 operating sites.

• Designed and implemented manifold for membrane filters on a high purity water system that supplied critical manufacturing operations.• Managed favorable $300,000 budget allocated to various capital projects.• Lead initiative to eliminate backlog of overdue non-conformances (NC) resulting in zero overdue NCs within 90 days. • Developed NC investigation guidelines resulting in a cultural shift in department’s approach to addressing NCs.• Lead team of safety personnel for the site-wide ergonomics initiative resulting in an 82% reduction in high-risk tasks.

• Redesigned AQL boards to better identify membrane defects on tablets resulting in greater customer safety. • Standardized production area safety zones by creating a color-coded key and mapping the facility. • Researched and assisted in the procurement of ultrasonic cleaners to eliminate manual cleaning of parts and increase throughput.

• Analyzed and revamped the water treatment facility, saved $100,000/year in recovered water with no capital invested. • Developed new operating procedures for the water treatment facility in order to reuse out of service pipes.• Constructed and maintained a foul water diagram and mass balance spreadsheet for the refinery. • Saved $68,000/year in wasted water by using flash calculations to solve pressure problems in the catalytic cracker/gas plant. • Became proficient in reading and understanding P&ID’s.

Bachelor Of Science (B.S.), Chemical Engineering

Activities and Societies: Co-Founder & President: International Society of Pharmaceutical Engineers (ISPE), American Institute of Chemical.

Engineering