Senior Consultant

• Jun 2021 - Present

Pfizer Inc.o Responsible for execution of CQV, engineering, and ops readiness activities for $400MM+ projecto Provided project updates and managed communication strategy to executive Pfizer leadership o Managed FAT execution, process design completion, and equipment readiness activitieso Developed commissioning documentation execution plan with technical teamo Supported project controls team in cost/schedule managementXellia Pharmaceuticalso Managed client relationship in between Emendo and Xellia Pharmaceuticals – reported directly to VP of North American Operations at Xelliao Managed validation, commercial ramp up, and batch release of three IV Vancomycin presentations  Developed site wide project plan in Smartsheet with leadership team and conducted daily meetings to track progress for different work streams  Worked closely with MST and ops to determine PPQ requirements and ops readiness needs  Reduced average batch record review process duration by ~75% over the course of 3 months  Created several Smartsheet dashboards tracking deviations, MBR review timeline, and QC sample processing times related to batch release  First 3 batches released by Sep 2021 – 5 additional batches to be released by EOYo Provided strategic consultation and crisis management support to senior leadership team at Xellia’s Cleveland site in development and execution of Vancomycin validation, production, and batch release plano Supported site in assessing potential tech transfer opportunities/partners based on operational capabilitieso Directly managed junior consultants at client site and provided direction and guidance on their projects Junior consultant projects included lean implementation, quality system optimization, engineering/maintenance shutdown management, etc. Show less

Management Consultant - Project Leader

• Nov 2019 - Jun 2021

o Project manager for validation of three presentations of generic IV Vancomycin at Xellia Pharmaceuticals site  In March of 2020, site redirected effort towards Gilead tech transfer due to coronavirus pandemico Built tech transfer project plan for Gilead’s antiviral drug, Remdesivir with cross functional site leadership teamo Managed operational readiness workstream for Remdesivir tech transfer from Gilead to Xellia  Worked directly for director of operations in developing operational readiness strategy  Determined with operations team which SOPs, MPRs, OJTs, etc. needed to be modified/created and managed the execution of the work  Developed buffer preparation and pH adjustment process with operations team  Facilitated discussions in between Gilead technical resources and Xellia operations to upgrade equipment to allow for Remdesivir production  Managed development of training plan with internal training resourceso Mentored and provided guidance to junior consultantso Developed/rolled out departmental shift handover and daily activity tracking boards across the site at Xellia Show less

AlbuRx® Process Scientist

• Sep 2017 - Nov 2019

o Process/data owner for AlbuRx® final formulation, sterile filtration, and filling operation responsible for generating over $200 MM in revenue annuallyo Interim manager for department for ~4 monthso Developed and executed density target modification analysis that generated ~$8,000 in additional revenue per batch and over $1MM of additional revenue per yearo Developed OEE model and ops KPIs visually representing efficiency and sources of product and time losso Reduced filling times by ~40% over the course of a year through working with vendor and manufacturing teamo Managed team of engineers and operators in optimizing streamlining the bulk transfer process and reducing the need for process interventionso Supported quality operations in RCAs as well as in executing CAPAs in response to deviationso Managed several process improvement projects including qualification of more robust tubing manifolds, sterile connectors, and new, optimized filling needles Show less

Process Engineer

• Nov 2015 - Sep 2017

o Lead engineer for fractionation department responsible for generating over $900 MM in revenue annuallyo Led a cross functional optimization task force through the execution of 40+ improvement projects resulting in ~33% increase in department production capacity and over $200 MM increase in revenue per yearo Designed and executed several $100K+ capital and expense process optimization projects and coordinated biannual department shutdownso Developed tech transfer document and supported process development team in transfer of process from Switzerland site to Illinois site for CSL112, a global R&D initiative to isolate and purify ApoA-1 (primary protein found in HDL) from an existing process waste streamo Analyzed process data to assist with troubleshooting of production issues and to develop optimization projects as well as assessing their success after implementationo Supported quality operations in deviation investigations by completing RCA and executing CAPAs Show less

Operations Management Trainee - 2nd rotation

• Jul 2014 - Nov 2015

- Manage team of 15+ mechanics, electricians, and stationary engineers in driving continuous plant improvement and ensuring sustainable equipment performance.- Lead and participate in technical problem solving activities, break down analysis, and process improvement projects throughout factory.- Supervise maintenance and engineering activities throughout factory.- Develop team and personal technical management skills- Approve spending for projects and equipment repair work.- Plan on leading several small capital projects in preparation for third rotation in program as project engineer on large capital project within Nestle USA.- Plan on receiving DMAIC training and completing project before end of the year. Show less

Operations Management Trainee - 1st rotation

• Aug 2013 - Jul 2014

Operations Management Trainee – 1st rotation - Part of engineering team on ~$24 million capital project in which a coffee filling line was installed in factory. o Lead a factory acceptance test (FAT) in Parma, Italy from Nestle USA side for $1 million+ piece of equipment Participated in qualification and testing of equipment. Represented Nestle USA (Freehold coffee factory) at FAT and collaborated with vendor to alignment and execution of deliverables. Worked with technical expert from Nestle R&D Switzerland to ensure necessary quality, safety, and performance standards of equipment.o Participated in factory acceptance test in Scwhabisch Hall, Germany for $1 million+ piece of filling equipment and assisted in qualification and testing.o Conducted assessment on equipment to determine how $85,000 should be spent on spare parts.o Created functional location structure, preventative maintenance plan, and spare parts strategy and began to implement information in SAP.o Worked with operations start up team to ensure that production line would sustainably transition into functioning as a part of the factory.o Part of team selected to visit similar production line in a greater London Nestle coffee production facility and participated in assessment of line in addition to assistance in training of Nestle USA personnel on equipment.- Implemented safety permit distribution and tracking system allowing at-risk activities in a large, technical factory to be highly visible.- Completed short stint as production supervisor for a highly technical tea extraction process in which 20+ process operators were managed. Show less

Teaching Assistant

• Sep 2012 - May 2013

Engineering Intern

• Jun 2011 - Aug 2011

o Conducted lab testing with compositions of cleaning materials for various applications o Worked with customers and adjusting product development to their specifications o Dealt with scaling up of compositions from a lab to industrial setting o Conducted lab testing with compositions of cleaning materials for various applications o Worked with customers and adjusting product development to their specifications o Dealt with scaling up of compositions from a lab to industrial setting

Student Co-op

• Jun 2010 - Mar 2011