John Wass, Cpip Email & Phone Number

Rosemont, IL, US

Capstone Development Services is an innovative shared services development company focused exclusively on complex generic pharmaceuticals and medical devices. Founded by strategic healthcare investor Water Street Healthcare Partners, Capstone leads development, manages regulatory services, and achieves timely approval of healthcare products through.

Deerfield, Illinois, US

Lead engineering operations for Baxter’s Pharma business segment, which contributes annual net sales of $3B and is comprised of divisions spanning sterile injectables, anesthesia, compounding, and contract manufacturing solutions. The Pharma engineering organization includes equipment design/ build & tooling, process automation & integration, sustaining &.

Deerfield, Illinois, US

Expanded role to lead a diverse and talented mechanical, electrical, and controls engineering services team with a global customer base spanning over 9 countries and nearly 20 sites with ~$12MM in services delivered annually across 4 GBUs. Expertise in internal design and integration as well as external turn-key partnerships to fulfill Baxter’s global.

Deerfield, Illinois, US

Formed new Center of Excellence within Global Engineering and Manufacturing Strategy comprised of a programmatic team serving as the trusted technology partner for our Pharma GBU and Regional profit centers spanning 5 sites across the U.S., PR, Germany, and India.We deliver short-term value to our stakeholders by championing iterative improvements to asset.

Copenhagen, DK

Formed the MS&T organization and provided leadership to the NPI/ Tech Transfer, Process Engineering, and Site Validation functional areas, while providing technical operations support for strategic site projects and CMO business development opportunities. Tasked with the creation, standardization, and implementation of MS&T business processes to enable the.

Indianapolis, Indiana, US

• Global business lead responsible for defining and maturing the Process Lifecycle, Technical Transfer, and New Technologies discipline leads and SMEs to help clients rapidly deploy safe, efficacious drug products to the.
• Set vision, develop strategy, and support a team ~25 agents delivering $6MM in YOY labor sales across U.S., Europe, and Asia.
• Program lead of a $35MM domestic site-to-site product portfolio transfer (CMO to In-house) for the 2nd largest U.S. market share manufacturer of large volume parenteral drug solutions in I.V. flex bag containers..
• Product portfolio assessment for strategic “Make vs. Buy” decision for 2nd product portfolio transfer
• Led C-level off-site strategic planning and commercialization road mapping for Phase 1/ 2 viral vaccine CDMO

Indianapolis, Indiana, US

• Emerging business unit leader responsible for technical consulting, project management, industry leadership, quality system development, and client business development in support of CAI’s Technology Transfer services.
• Parenteral Drug Association TT Interest Group technical lead, which is tasked on a tactical supplement to TR-65, Technology Transfer for rapid, repeatable technology transfers.
• Technology transfer of a legacy product to an international $350MM greenfield facility (U.S. to India) using a retrospective QbD approach. Sending Unit team of 10 client resources with coordination of a distributed.
• Receiving Unit process transfer and validation remediation lead for a brownfield domestic, site-to-site technology transfer of an aseptically filled fractionated blood plasma product
• Drug shortage parenteral product re-launches and global expansion of on-market products to new markets

Indianapolis, Indiana, US

• Technical lead and project manager with increasing responsibility focused on manufacturing process cost savings, post-approval changes, and implementation of enterprise data management and manufacturing process control.
• Implemented North American EAMS solution standardizing the maintenance business process across 5 sites
• Site PM for a formulation, filling, and finish facility manufacturing terminally sterilized parenteral drug products
• Implemented manufacturing execution and distributed control systems across multiple unit operations for a vertically integrated lyophilized recombinant protein drug substance and aseptic form, fill, finish facility
• Implemented global LIMS solutions that have been as complex as 5 divisional sites spanning 3 countries
• Start-up of the QC lab and support processes for a 900MM greenfield flu cell culture facility

Indianapolis, Indiana, US

CAI is an industry leading global, employee-owned, technical and consulting services company focused on the Pharma, Biotech, and Medical Device industries. They provide integrated service solutions to complex problems from early stage development program management through full scale operations and commercial launch. Cumulative services in excess of 660MM.

VC funded start-up medical device company specializing in the development of novel in situ polymerizing hydrogels to be used as internal sealants. Licensed 1 product to Becton Dickinson Ophthalmic and launched 2 products to market privately. Acquired by Stryker for $220MM.

Charlottesville, VA, US

Lab-on-a-chip research group developing technology used to miniaturize and streamline the chemical processes involved in biochemical analysis, including DNA testing. Research spun off as MicroLab Diagnostics, Inc., and was acquired by ZyGEM, Inc. in 2010.

Charlottesville, VA, US

College bowl record of 2-1 defeating two Top 25 opponents. Set up and help execute skill position drills, provide defensive signal calling during practice, and determine opponent offensive personnel changes on game day.

Bachelor'S Degree, Chemistry

Leading Strategically

High School, International Baccalaureate