Lead cross-business integration and internal/external collaborations to deliver new products, product combinations, and services driving greater revenue through innovation.Established program strategy, vision, roadmap, and governance structure to enable both near term and long term revenue.

Led holistic data and digital strategy development and program execution for six CMC functions spanning three therapeutic modalities. Served as divisional representative for enterprise digital and data leadership teams. Established program governance and managed a portfolio of 30 projects ($6M total investment). Managed a team of five analytics experts and led cross-functional delivery teams IT and business SMEs.- Established first-ever data and digital program governance board and key… Show more Led holistic data and digital strategy development and program execution for six CMC functions spanning three therapeutic modalities. Served as divisional representative for enterprise digital and data leadership teams. Established program governance and managed a portfolio of 30 projects ($6M total investment). Managed a team of five analytics experts and led cross-functional delivery teams IT and business SMEs.- Established first-ever data and digital program governance board and key performance indicators to effectively prioritize and monitor project portfolio enabling $5M in value creation within the first year of the program while strategically enabling $20M in growth opportunities.- Created outreach programs and learning pathways to build competencies in data, analytics, and business acumen that exceeded engagement targets year over year. Over 50% of the division leveraged learning pathways within the first year and a half of the program.- Drove cross-functional teams to deliver lab automation ranging from measurement systems, centralized data and knowledge assets, critical infrastructure, and in silico experimentation resulting in an overall productivity increase of 10%, including workflow acceleration of 40%. -Oversaw integration of Labware ELN/LIMS, synTQ, PI, S3, and Snowflake with Posit Connect analytics applications. Show less

Spearheaded development of fully integrated process analytical technologies and process control strategies across development and commercial manufacturing platforms by closely partnering with development, regulatory, manufacturing, and quality leaders. Directly managed a team of three PAT experts and led many cross-functional delivery teams composed of IT, automation, manufacturing, and development SMEs.- Implemented pain-point identification and prioritization models to select and… Show more Spearheaded development of fully integrated process analytical technologies and process control strategies across development and commercial manufacturing platforms by closely partnering with development, regulatory, manufacturing, and quality leaders. Directly managed a team of three PAT experts and led many cross-functional delivery teams composed of IT, automation, manufacturing, and development SMEs.- Implemented pain-point identification and prioritization models to select and deliver innovations that increased productivity five times while reducing process risk. Awarded the 2021 John Borland Innovation Award presented by the Britest Organization.- Served as Chief of Staff on a six-month assignment reporting directly to the SVP of Development. Crafted business cases for executives and developed and monitored key performance indicators for the function.- Chaired a global innovation investment program with a $2M annual budget for early-phase technology feasibility assessments resulting in the completion of more than 60 feasibility studies in two years.- PAT integrations included vibrational spectrometers (Raman, NIR, FTIR), simple sensors, and online sampling systems with control systems (DeltaV, synTQ, PI) and enterprise applications for GMP process control and workflow automations. Show less

Drove the development, commercialization, and regulatory filings of fully integrated process analytics technologies (PAT) for biologics’ drug-substance manufacturing in RTP, NC as well as the Solothurn, Switzerland, Next Generation Manufacturing facility. Executed application feasibility, technology selection, and technology industrialization in development and commercial environments.- Led a team that developed and implemented advanced control approaches which included holistic system… Show more Drove the development, commercialization, and regulatory filings of fully integrated process analytics technologies (PAT) for biologics’ drug-substance manufacturing in RTP, NC as well as the Solothurn, Switzerland, Next Generation Manufacturing facility. Executed application feasibility, technology selection, and technology industrialization in development and commercial environments.- Led a team that developed and implemented advanced control approaches which included holistic system validation for instrument, software, and control logic, as well as integration with enterprise systems (e.g., LIMS and ERP systems) using synTQ, DeltaV, Unicorn, PI, and LIMS.- Developed standards and drove automation efforts to develop, validate, and maintain chemometric models, batch evolution models, and CPV plans to support process control strategies and continued process verification. Leveraged MATLAB and SIMCA software.- Directed global contract negotiations and architecture designs for real-time measurement systems that resulted in more than 20% savings ($2M) of capital budget.- Awarded 2020 Biogen CEO Award for realizing the Next-Generation Manufacturing process control strategy. Show less

Drove the development, commercialization, and regulatory filings of fully integrated process analytics technologies (PAT) for biologics’ drug-substance manufacturing in RTP, NC as well as the Solothurn, Switzerland, Next Generation Manufacturing facility. Executed application feasibility, technology selection, and technology industrialization in development and commercial environments.Developed and executed data management strategies for pharmaceutical and biopharmaceutical drug… Show more Drove the development, commercialization, and regulatory filings of fully integrated process analytics technologies (PAT) for biologics’ drug-substance manufacturing in RTP, NC as well as the Solothurn, Switzerland, Next Generation Manufacturing facility. Executed application feasibility, technology selection, and technology industrialization in development and commercial environments.Developed and executed data management strategies for pharmaceutical and biopharmaceutical drug substance and drug product manufacturing.Supported investigations and root cause identification through univariate and multivariate data analysis. Show less

Drove the development, commercialization, and regulatory filings of fully integrated process analytics technologies (PAT) for biologics’ drug-substance manufacturing in RTP, NC as well as the Solothurn, Switzerland, Next Generation Manufacturing facility. Executed application feasibility, technology selection, and technology industrialization in development and commercial environments.Developed and executed data management strategies for pharmaceutical and biopharmaceutical drug… Show more Drove the development, commercialization, and regulatory filings of fully integrated process analytics technologies (PAT) for biologics’ drug-substance manufacturing in RTP, NC as well as the Solothurn, Switzerland, Next Generation Manufacturing facility. Executed application feasibility, technology selection, and technology industrialization in development and commercial environments.Developed and executed data management strategies for pharmaceutical and biopharmaceutical drug substance and drug product manufacturing. Show less

Lead the process analytics initiative for Oral Solid Dose by providing manufacturing process and informatics expertise. Provide support and leadership for Process Analytics Technology (PAT) initiatives and other continuous improvements. Provides trending and analysis support for investigational teams and ensure manufacturing compliance.Apply statistical process controls and process modeling methodologies for troubleshooting and process improvements.

Drove development, commercialization, and regulatory filings of advanced control technologies for oral solid dose development and manufacturing. Implemented platform granulation process controls for generic and branded products. Established and implemented site-level policies and procedures for multivariate model life-cycle management. Led the development of CPV programs for pharmaceutical drug products.

Led a laboratory of five analysts that developed and maintained more than 50 chemometric models critical to the operation of nine corn milling sites distributed across North America. Supported corn milling sites as a near-infrared (NIR) spectroscopy, FTIR spectroscopy, and chemometric modeling expert during investigations and site-training activities. Led feasibility assessments for new technologies and modeling applications.

Led the development of physical characterization methods and performed analysis supporting early to late-phase asset development. Supported the development of process analytical technologies to assess crystal form in real time. Mastered physical characterization techniques that included microscopy, spectroscopy, x-ray diffraction, and particle size analysis.