Harish Edamadaka

Merck & Co., Inc.
Vaccine Technology & Engineering (Varicella Virus Vaccine) Durham, NC
Integrated Process Team - Field Engineering Specialist Feb 12 - Present

• Lean Six Sigma Green Belt Certified: Utilize knowledge and tools to foster multiple continuous improvement projects and support the development and implementation of shop floor process improvements and atypical investigations (FMEA,
Playbooks, Fishbone Analysis, DMAIC) which have achieved over $5M in savings.
• Provide shop floor end-to-end technical support for the sterile bulk manufacturing processes of Varicella Virus Vaccines, a
billion dollar vaccine franchise, including viral propagation, cell culture expansion, and sterile bulk filtration.
• Responsible for making tactical rapid and impactful decisions via real-time technical troubleshooting support including
electronic batch record review, assessing sterility investigations, executing validation protocols and studies, and authoring
technical investigations.
• Lead and investigate multiple real-time shop-floor quality investigations to minimize and proactively prevent reoccurrences of process deviations and product loss. Responsibilities range from providing detailed root-cause analysis, product quality
impact assessment, CAPA management, standardized playbook creation, and determining corrective actions. Results
have led to 30% reduction in process deviations and over $2M in releasable quarantined product.
• Served as a technical subject matter expert during manufacturing investigations to determine product impact and the ability to release the drug substance to formulation/filling
• Supervise and mentor 5-7 teams of hourly Technicians to execute critical aseptic processes. Ensure compliance, SOP,
CAPA implementation, and good documentation practices are achieved real-time.
• Collaborate in a cross functional global team achieving a 30% reduction of process deviations while supporting regulatory
filings, audits and inspection activities in order to maintain high quality and robust supply.
• Facilitate and lead daily shift change meetings with Operations, Quality, Automation to effectively communicate, plan,
schedule, and coordinate day-to-day production activities and technical issues to prevent reoccurrences.
• Utilize Manufacturing Execution System and Delta V software to analyze and measure daily critical processing
parameters, KPI, and production activities while communicating daily issues to senior management.

• Provide shop floor end-to-end technical support for the sterile bulk manufacturing processes of Varicella Virus Vaccines, a billion dollar vaccine franchise, including viral propagation, cell culture expansion, and sterile bulk filtration.
• Responsible for making tactical rapid and impactful decisions via real-time technical troubleshooting support including electronic batch record review, assessing sterility investigations, executing validation protocols and studies, and authoring technical investigations.
• Lead and investigate multiple real-time shop-floor quality investigations to minimize and proactively prevent reoccurrences of process deviations and product loss. Responsibilities range from providing detailed root-cause analysis, product quality impact assessment, CAPA management, standard playbook creation, and determining corrective actions. Results have led to 30% reduction in process deviations and over $2M in releasable quarantined product.
• Served as a subject matter expert during manufacturing investigations to determine product impact and the ability to release the drug substance to formulation/filling
• Supervise and mentor 5-7 teams of hourly Technicians to execute critical aseptic processes. Ensure compliance, SOP, CAPA implementation, and good documentation practices are achieved real-time.
• Collaborate in a cross functional global team including resolution and reduction of process deviations, support for regulatory filings, audits, and inspection activities in order to maintain high quality and robust supply.
• Lean Six Sigma Green Belt Certified: Utilize knowledge and tools to foster multiple continuous improvement projects and support the development and implementation of shop floor process improvements and atypical investigations (FMEA, Playbooks, Fishbone Analysis, DMAIC) which have achieved over $5M in savings.
• Facilitate and lead daily shift change meetings with Operations, Quality, Automation to effectively communicate, plan, schedule, and coordinate day-to-day production activities and technical issues to prevent reoccurrences.
• Utilize Manufacturing Execution System and Delta V software to analyze and measure daily critical processing parameters, KPI, and production activities while communicating daily issues to senior management.

Merck & Co., Inc.
Vaccine Technology & Engineering (Varicella Virus Vaccine) Durham, NC
Staff Engineer - Tech Transfer, Start-up Vaccine Facility Aug 10 - Feb 12

• Successfully performed technical transfer and start-up activities for the start-up bulk vaccine production facility including
equipment installation, validation management, cycle development, authoring protocols towards licensure, establishing
critical process parameters, leading field studies and experiments.
• Lead supplier relationship initiative to meet design specifications which resulted in reaching on-time qualification goals.
• Pioneered a low cost novel method to perform temperature mapping and validation of new critical temperature equipment
yielding an optimized thaw model that was filed in the product licensure as a CPP.
• Performed experimental design, Design of Experiment, and data analysis to support technical transfer from start-up facility to full scale commercial bulk manufacturing of Varicella Virus Vaccine, , a billion dollar live vaccine franchise.
• Coached and trained over 15+ technicians through preparation for Engineering lots, development of standardized work,
Kaizens to refine manual operations, SOP shakedown, etc.
• Performed capacity and demand analysis to define critical process parameters by utilizing Six Sigma tools to optimize
vaccine potency during thaw bath operations.
• Used statistical analysis to evaluate factors that influence heat transfer of thawing bulk Virus fluids from a frozen state to a
liquid state. Analysis achieved better understanding of thawing process which drove 15% in efficiency.

Merck Manufacturing Development Program - (A two-year rotational development leadership program)
Vaccine Technology & Engineering (Rotation 3 of 3) Durham, NC
Associate Specialist, Engineering Start-up Technical Transfer Oct 09 - Aug 10

• 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 engineering studies to determine equipment-to-equipment variability of brand new Critical Temperature units
which provided foundation for standardizing process variation.

Global Procurement (Rotation 2 of 3) Whitehouse Station, NJ
Business Analyst, Research Labs Mar 09 - Oct 09

• 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.
• Handled logistics and coordination of clinical vendor capability presentations.

Global Distribution & Logistics (Rotation 1 of 3) West Point, PA
Associate Supervisor, Vaccine Warehouse Operations Aug 08 - Mar 09
st
• 1 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%.

Merck & Co., Inc.
Global Pharmaceutical Commercialization West Point, PA
Packaging Engineering Intern Mar 06 - Sep 06

• Supported Phase II and III products by studying physical and chemical stability over time to help determine optimal
packaging configuration.
• Performed development studies on the Residual Seal Force tester, an instrument in sterile filling inspection work suites.
• Initiated development of a rapid dye ingress test aimed at reducing test time from 24+hrs to 60 minutes.
• Led setup and execution of stability experiments to determine optimal packaging configurations.