Mike Martin Email and Phone Number

CAI (Commissioning Agents, Inc.) delivers integrated solutions that achieve operational readiness and operational excellence. We design, deliver, operate, and maintain quality-critical manufacturing (GMP related) or mission-critical facilities. Our engineering, technical, and consulting services encompass all aspects of operation: equipment, automation, process, and human performance. Our high performance teams, technology, and expertise combine to deliver our client's critical projects, crucial products, and reliable operations thereby providing superior advantage in a competitive global marketplace.CAI exists to be the trusted solution for our clients as they build a better working world and improve the human experience.

Responsible for:Company Vision and DirectionMarket Connection and InfluenceCompany PerformanceCompany Culture and Employee EngagementEthics and ComplianceGuides the senior leadership team including Operations, Strategy, Talent, Technology, and Corporate Services with the sole purpose of serving clients as a trusted partner and building a better working world.

Overall responsibility for five key strategic areas of the corporation:1. Organizational development, including long-range planning and initiatives2. Preparation and execution of annual business plans3. Maintenance / updating of long-range Strategic Plan4. Oversight / monitoring / evaluation of business area leaders and the strategic development council5. Business development, marketing, sales and key account management

• Responsible for growing and leading the program and project management services business area. • Our Program & Project Management (PPM) professionals successfully execute projects and lead programs (collections of projects or sub-projects) with the client's best interest in mind - a fully operational, efficient, and compliant production facility delivered on time and within budget. • The Program/Project Manager is the point of accountability; bringing the team together and accomplishing difficult objectives. He/she keeps the long-term goal of your program or project in view and integrates the elements of the program/project while avoiding the conflicts which normally arise between connected projects and/or between project functional teams.• PPM personnel have capabilities across the program elements related to capital improvement, process improvement, process optimization, and management of resources and suppliers. PPM personnel combine years of experience and CAI’s unique processes with high standards of ethics and integrity. This enables us to serve in the client's stead making the critical, complex decisions which are required for successful, sustainable programs and projects. • The Global Director engages directly in strategic projects to establish new services, or to engage with new or existing accounts to provide high-end or door-opening services while applying engineering, operations, and project management expertise and experience acquired over several decades.

Responsible for leadership of a major capital design and construction project to expand biotechnology manufacturing capacity in Kinsale, Ireland. Responsible to lead a team supporting multiple project functions and craft workers on the construction site reporting to 10 major construction partners operating using lean construction concepts. The team size will peak with more than 200 project support employees and more than 600 craft workers. These construction partners are organized into collaborative team via a unique contracting system which inspires the contractors to work together and achieve enhanced profits as a result of the collaboration. The project scope includes bioreactors, harvest, and purification as well as supporting utility and air handling systems. The project is off to a strong start and its cost and schedule are on track.

Responsible for project leadership of a $350MM design and construction project to expand insulin formulation and filling capacity in Suzhou, China. Responsible to lead a team of 200 people supporting multiple project functions and more than 1,300 craft workers on the construction site reporting to 7 major construction partners. Project scope included an administration facility, a laboratory, site utilities, and a manufacturing facility. After taking the leadership role for this project, the forecasted cost was reduced by $25MM and a design schedule delay was largely recovered. The construction quality was outstanding and the aseptic processing areas achieved a very high standard for finished quality. The construction safety record for the project was also outstanding with no serious injuries occurring in over 5.5 million work hours (this is a record for Eli Lilly and Company).

Responsible for developing and implementing strategic improvements to corporate engineering methodology for facility and process design. These methods are applied to an annual corporate capital investment plan of greater than $1 billion. Responsible for improving the effectiveness and efficiency of investments through design oversight in order to achieve the optimal balance of cost and risk management. The strategic improvements were implemented and integrated among worldwide manufacturing sites, corporate engineering, and external engineering partners.

Business leader for the worldwide contract manufacturing of pharmaceutical drug delivery devices. Responsible for leading a team of 180 people engaged in manufacturing and quality functions. Responsible for the commercialization planning for more than 10 device programs from research and development leading to high volume production through contract manufacturing partners located globally with a contracted workforce of more than 600 employees. Responsible for manufacturing and pre-assembly of device components and for supporting final assembly and packaging operations of more than 15 commercialized devices. Delivery devices include pens used for the injection of insulins and osteoporosis medications, and topical application devices. Responsible for product support during the product life cycle and for the technical improvement agenda of existing devices. Also, responsible for supplier relationship management of 6 global manufacturing partners including influencing manufacturing improvements, quality improvements, and cost reduction efforts.

Director of Engineering Services for API (Active Pharmaceutical Ingredient) Manufacturing in Indianapolis. Responsible for support insulin manufacturing operations. Responsible for leading a team of 165 employees with a budget of $60MM in the disciplines of process engineering, process control engineering, process analytics technologies (PAT), plant engineering, project engineering, and maintenance, reliability, and instrumentation. Provided business leadership as a member of the plant lead team developing and implementing the manufacturing strategy for the site.

Director of Engineering for a large biotechnology facility in Puerto Rico. Responsible for Start Up, Commissioning, and Qualification of the $850MM insulin fermentation and purification plant. Also responsible for leading the engineering and maintenance team of 65 people for this plant after commencement of manufacturing operations.

Project Manager responsible for a $110MM capacity expansion of an insulin biotechnology purification facility. Responsible for leading the cross-functional team which performed commissioning, qualification, validation, training, etc.

Responsible for leading insulin-filling operations in an aseptic pharmaceutical manufacturing facility. The high speed assembly line operations included vial sterilization, solution filling and dose control, stopper application, capping, vial identification, and vial inspection. Led the operations team of 100 employees engaged in the vial filling activities.

Served as the Engineering Manager for a dry products manufacturing facility in Puerto Rico. Plant manufactured oral antibiotics. Responsible for leading a team of 30 persons in the disciplines of plant engineering, project engineering, maintenance, reliability, process automation, and capital planning.

Served as a mechanical engineer in various assignments including: facilities design engineer, construction engineer, maintenance and utilities engineer, and small project manager.