Harish Edamadaka

MSAT lead for Vaxcyte's novel broad-spectrum pneumococcal conjugate vaccine (VAX 24 & VAX XP). Lead technical transfer and Phase 3 manufacturing readiness activities for the carrier protein manufacturing (CRM) process Provide leadership on CRM protein carrier cGMP manufacturing intermediate scale-up, technical transfer, and critical raw material supply chain management. Interface with Process Development and CMOs to support scale up to large scale Phase 3 process. Manage complex critical raw material development to GMP manufacturing, material handling to support drug substance commercialization of eCRM

Provided technical expertise, product leadership, study coordination guidance, hands-on execution support towards technical transfer of new drug substance start-up manufacturing facilities or the Human Papilloma Virus (HPV) Recombinant Vaccine (Gardasil) Led implementation of major process change at company record speed (8 months) encompassing project formation, Process Performance Qualification (PPQ) strategy, execution, close-out, and regulatory filing commitments across two drug substance commercial factories. Led analytical process comparability assessment to support major commercial process change. Partnered with Regulatory Affairs to Author technical and validation sections in license for worldwide submissions. Project has resulted in preventing over $150M in batch discards. Partnered with Process Development, Quality, Regulatory Groups and Executive Management in order to align strategic activities and help assure product/process integrity and regulatory compliance. Lead elemental impurities vaccine process developmental workstream to support process development, robustness, and characterization milestones . Champion new Continued Process Verification Plan (CPV) for Drug Substance manufacturing sites. Lead cross-site CIP harmonization initiative to improve cleaning performance. Interface with process development to foster innovative analytical solutions for characterizing and diagnosing process conditions. Led cross-site technical investigation and development on stainless steel passive layer surface chemistry, metals, and rouge studies to identify optimal process conditions for life cycle management. Implemented initial development to support process monitoring standard characterization plans across drug substance sites to build process robustness conditions Charted new major complex project to implement new purification process change across the franchise involving efforts to improve control of disulfide bond formation kinetics.

Lead for technical transfer of new start-up viral vaccine manufacturing Drug Substance facility. Supported new facility from design phase to engineering performance of capital project (~$400M) Develop, Define, Qualify, and Implement end-to-end Single Use Disposable Technology and Development Testing (design/material selections, equipment sizing, supplier selection, development, Extractable and Leachable, CCIT, transport/shipping, qualification), etc. Responsible for providing oversight and directing technical transfer team to develop and define process design requirements for critical systems/equipment (Centrifugation, Tangential Flow Filtration, Sterile Filtration, Incubators, CIP, Fixed/Portable Tanks, etc.). Key activities include P&ID reviews, equipment verification against processes requirements, component criticality assessments, etc. Lead cross functional global team to evaluate, negotiate, and select designs and suppliers to achieve strategic sourcing and franchise goals. Design and manage End to End study design, execution, and coordination of developmental commercial Drug Substance Stability Studies, a critical component for facility license. Manage technical team to author, execute, and or approve key engineering design, Process Validation, and licensure milestones (URS, FAT, SAT, FRS, Risk Assessments, etc.) Pioneer new qualification methodology and practice for Single Use Systems for new start-up facility. Lead development of harmonized strategy for automated Batch Reporting methodology and user requirements. Start-up cGMP Facility will manufacture influenza derived drug substance. Fluzone is a ~$1.3B franchise.

Responsible for leading, designing, and executing start-up tech transfer milestones at the Greenfield state-of-the-art manufacturing facility in Covington, GA. (FDA licensure received in 2018.).Fractionation site is intended to separate and purify Immunoglobulin and Albumin proteins (Plasma Protein Manufacturing). Responsible for developing, designing, and executing technical transfer studies and strategies to directly support Engineering Runs and PPQ strategies for on-time facility licensure. Managed various cross functional process risk assessments (Microbial and Mixing) which produced harmonized strategies and increased manufacturing flexibility. Designed, authored, and managed Bioburden evaluation hold study to support Process hold time and Microbial Risk mitigation strategies. This is Takeda’s (previously Shire's, Baxalta's, Baxter's) biggest capital project (>$1.5B) in company history.

Supported tech transfer, PAI readiness, and facility licensure of the mammalian cell culture process of the Durham, NC start-up bulk (Drug Substance) facility for the live virus vaccine (Varicella). Technical support lead for the purification suite in a start-up live virus vaccine facility. Provided real-time technical process/product support for Single Use Cell Expansion, Viral propagation, Filtration, Purification of a live virus vaccine manufactured using mammalian cell culture. Extensive experience targeting key timing commitments, careful determination of root cause, product disposition, and appropriate corrective/preventive actions in a cGMP environment. Collaborated in a cross functional team with a focus on resolution and reduction of process deviations, support for regulatory filings, audits, and inspection activities in order to maintain high quality and robust supply. Participated in major submissions of critical documents to key regulatory agencies. Lean Six Sigma Green Belt Project: Pioneered new novel method for measuring residual ice and internal can temperature which supported development of critical process parameters. Project resulted in higher yield recovery in the thaw operations. The Durham vaccine manufacturing site is 700,000 sq ft, designed to produce 30MM units a year for chicken pox, MMR, and shingles vaccines. Over $1.5 Billion dollar investment.

Merck Manufacturing Development Program (Rotation 3 of 3) Vaccine start-up tech transfer of bulk manufacturing process from West Point, PA to Durham, North Carolina • Pioneered new method development process of measuring residual ice resulting in 96% product yield in thaw process • Developed complex Design of Experiment (DOE) to evaluate critical factors that contribute to vaccine potency loss resulting in optimized model used for thawing frozen bulk harvested viral fluids. • Performed URS, FAT, and engineering studies to determine equipment-to-equipment variability of brand new Critical Temperature units which provided foundation for standardizing process variation.

Merck Manufacturing Development Program (Rotation 2 of 3) Research Procurement • Provided analytical sourcing support for the Merck Ancillary Supply Clinical Operations Team including contract negotiations, conducting market research, authoring contract amendments. • Led process improvement project team aimed at reducing clinical contract cycle times by 40%. • Collaborated with Legal, Finance, and Insurance to plan, execute, and author financial solvency risk assessments for clinical equipment suppliers.

Merck Manufacturing Development Program (Rotation 1 of 3) Global Logistics / Warehouse Management / Global Supply Chain • 1st shift lead supervisor of vaccine distribution center pick/pack/ship small parcel operation, managing the day-to-day work, training, planning, and scheduling of 20 Merck union personnel. • Designed and developed automated picking process resulting in 50% increased order pick rate, reducing pack-out cycle time and reducing number of personnel per shift by 20%.

• Supported Drug Product Sterile Filling Operations with Atypical investigations, documenting corrective actions, and mechanical troubleshooting in aseptic manufacturing filling operations. • Developed and Executed IQ/OQ/PQ; led operational commissioning of peristaltic pumps.

• Supported Phase II and III products by studying physical and chemical stability over time to help determine optimal packaging configuration. • Performed container closure integrity development studies on the Residual Seal Force tester, a key test implemented in sterile filling facility.

• Responsible for investigating, analyzing, and reporting weekly production results • Performed scheduling and auditing of weekly production and population • Managed production scheduling for nine packaging lines in a 24/7 manufacturing environment