Loki Ganta

• Managed project timelines, priorities, and stakeholders, coordinating between Manufacturing, Engineering, and Leadership. • Mitigated operational risk by establishing standardized build and testing protocols, ensuring 100% compliance. • Executed cost-saving and process optimization strategies for high-complexity subassemblies by leveraging Lean methodologies. • Ensured plant readiness and compliance for internal, external, and partner audits. • Developed 30+ Operating procedures for assembly and material staging using PFEP methodology, establishing kitting procedures and JIT delivery protocols. • Implemented optimized cycle counting and variance analysis procedures, improving inventory accuracy from 91% to 96%.

• Lead logistics projects, including designing, analyzing, and optimizing operational and distribution processes regarding people, quality, safety, velocity, and cost, utilizing SAP 4 HANA. • Designed and scheduled logistical audits that improved inventory accuracy and Kanban replenishment by 95% in the assembly areas. • Drove 40% reduction in point - of - use availability issues by leading cross-functional Kaizen events and executing structured A3 problem-solving methodology. • Established performance metrics and optimized picking and put‑away processes, increasing accountability and improving throughput by 10% • Supported projects on material handling automation with personnel safety, including AGV planning and collision avoidance systems. • Ensured compliance with OSHA safety standards and internal EHS procedures across warehouse and logistics operations. • Executed Inbound receiving project leveraging Lean and Six Sigma methodologies, generating $120K annual cost savings. • Performed Root cause analysis and executed 25+ corrective and preventive actions (CAPAs), enhancing material‑flow efficiency.

• Developed visual management systems and SOPs for logistics operations, reducing cold-chain temperature excursion events by 15% across network-wide warehouse and customer sites. • Established Standard Operating Procedures (SOPs) and Change Control protocols for pharmaceutical logistics operations, ensuring GxP compliance and operational efficiency • Supported development of a transportation network analysis tool, and evaluated 500+ global lanes and optimized 3PL partner selection, reducing distribution costs. • Rolled out temperature excursion monitoring platform across global shipping sites; trained 90+ stakeholders to drive cold chain operational excellence. • Managed monthly KPI reporting across 12 global manufacturing sites (CMOs); drove 20% improvement in order fulfillment accuracy through collaborative continuous improvement.

• Conducted real-time batch record reviews, supported lot/batch release, including room clearances and critical process audits, ensuring GMP compliance. • Designed and delivered onboarding training for new Quality associates on the Floor personnel, covering GMP procedures, deviation recognition, and manufacturing compliance requirements. • Initiated events/deviations and assisted in the timely closure of CAPAs, gap analyses, and product complaints. • Drove cross-functional collaboration among manufacturing, facilities, QC, and MS&T to achieve operational and compliance goals. • Provided end-to-end oversight of biological manufacturing workflows — spanning cell culture, fermentation, purification, and fill/finish • Ensured product safety, efficacy, and regulatory compliance by adhering to FDA regulations (21 CFR Parts 210, 211, and 600 series), cGMP requirements, ICH guidelines, and EU GMP standards

• Organized and executed 15 mock FDA interviews, resulting in a 20% improvement in team performance during actual FDA inspections for a pharmaceutical (fluid-based) batch-processing environment. • Successfully implemented corrective and preventive actions that resolved 95% of identified issues within the target timeframe, significantly improving operational compliance. • Adhered to GMP requirements per 21 CFR 210/211

• Led 90-member operations team to highest productivity levels for six consecutive months through data-driven decision-making, driving alignment with safety, quality, and delivery targets. • Increased usable workspace by 30% and workplace cleanliness audit score from 75 to 90 points by implementing 5S sustainability practices. • Boosted employee submissions for Kaizen initiatives by 40%, increasing the number of ideas from 20 to 28 per month through incentive programs. • Reduced product cost by 3% by optimizing consumable usage in Lead acid battery assembly. • Adhered to ISO/TS 16949:2009, ISO 14001 and ISO 9001:2008 standards throughout the Assembly

Evaluated Value-Added activities and Non-Value-Added activities by using Value Stream Mapping in the production of Control Head assembly line. • Applied Line of balance technique for elimination of buffers in the assembly line. • Reduced the cycle time from 16 seconds to 14 seconds by modifying existing Assembly layout