Robert Minderman Email & Phone Number

Cincinnati Metropolitan Area

Cincinnati Metropolitan Area

-Lead a cross functional team to develop a novel large volume injector in partnership with a pharmaceutical client-Responsible for the program management plan, including strategic plans for quality, regulatory, HF, and design control-Manage client relationship working through issues such as CE marking, sterility assurance, and statistical approaches-Oversee, track, and report on progress to program milestones, issues, risks, and alignment between organizations-Act as a company SME for RFP and proposal development, drug development, and design control processes

Indianapolis, Indiana Area

-Provide support to molecule projects in the Diabetes and Immunology portfolio from pre- Candidate Selection to End of Phase 2, including development of plans, timelines, information management, and regular program updates-Control budget and schedules for a dynamic Phase 2 immunology project, with a development partner, undertaking 4 clinical trial programs simultaneously while using Next Generation Development methodologies-Develop budgets and schedules supporting development of a connected medical device in excess of $100M per year-On an interim basis, led the development of a medical device’s user interface in partnership with multiple external vendors, with stakeholders from Human Factors, Marketing, Medical, and Patient Safety, including 1 direct report-Oversaw logistics, schedules, and budgets for Customer Experience, Training, and Secondary Packaging workstreams supporting the development of a novel Insulin Pump-Author RFPs for the development of Med Device Training Systems, and resource augmentation for User Interface Associates and Systems Engineers

Indianapolis, Indiana Area

As a member of the Lilly Delivery, Device and Connected Solutions' Systems Engineering organization:-Acted in a dual role of Project Manager and Systems Engineer for a novel software and hardware , currently under development-Developed User Needs, and System Requirements, necessitating the execution of a Standards and Regulations check, for a novel device

Indianapolis, Indiana Area

-Directed creation of Early Feasibility Clinical Trial Development Plan for delivery device with embedded software, including many risk-based, company-first deliverables, such as a device evaluation strategy per FDA guidance-Documented test plans and testing results executed by internal and external testing groups for reusable needle-based injection device supporting ISO 11608 and IEC 60601 standards-Initiated project scheduling methodology, contacted vendors, wrote RFPs, and selected master scheduler to support complex medical device development project-Supported bioequivalence clinical trial for concentrated basal insulin, from device development to CT-site training-Led development activities for a co-packaged combination product to assist new insulin patients initiate their therapy-Executed design control deliverables to permit an on-time launch of ISO 11608 compliant basal insulin pre-filled pen injector

Indianapolis, Indiana Area

- Managed workload and performance of 5 engineers at customer site while maintaining my own client projects- Embedded as Process Mechanical Lead for single-use pharmaceutical delivery device assembly equipment - Developed User Requirements for medical device assembly equipment to follow client and industry standards- Partnered with client’s associates to develop vendor selection criteria for initial OEM selection- Facilitated development and performance of Safety Risk Assessment for assembly equipment in design stage- Member of equipment delivery team, meeting with vendors and developing appropriate OEM scope-of-work- Assisted in development of client’s complex business case for multi-million dollar international equipment capital project

Indianapolis, Indiana Area

Client: Eli Lilly and Company, Indianapolis, USADrug Delivery Device Commercialization / Manufacturing Group- Traveled internationally to supervise and guide fabrication, commissioning, and qualification of medical device assembly equipment- Delivered business critical assessments, reports, and studies while embedded in supplier's German site.- Developed risk-based calibration assessments following multiple stake holder’s policies and procedures- Excelled as Technical SME for assembly equipment manufacturing polymeric primary containers- Participated with commercialization of non-silicone lubricant and vision-based lubrication detectionClient: Bristol-Myers Squibb, Mt Vernon, Indiana, USALarge Dry Packaging Operation - Developed, performed, and analyzed DoE-based study for quality level of a major pharmaceutical packaging operation- Created and trained colleagues to methods for ongoing process capability study of GMP packaging lines.- Project management duties for packaging line shutdown, including simultaneous management of 2 capital projects, 4 routine maintenance issues, and line requalification, within a critical timeframe. - Performed multiple analysis to determine capital acquisition strategy to improve efficiency and ensure adherence to future regulatory requirements- Extensive involvement with Quality Event investigations and remediations in the role of technical lead.- Developed knowledge to become SME on slat-type and wheel-based tablet filling equipment- Presented quality and capital budgeting information to site leadership team multiple times for multiple departments- Gained familiarity with "Trackwise" CAPA and QE management system

Greater New York City Area

Led manufacturing engineering efforts to increase production 400% in 1.5 years with minimal headcount increase.Initiated company-wide equipment and process validation and documentation program in-line with ISO standards.Performed Installation and Operations Qualifications on production automation to reduce risk and assure quality.Developed novel packaging technique for next generation product to improve quality and reduce cost of assembly.Designed facility modifications to cope with increasing demands, by improving efficiency of process flows.Directed implementation of low-particle manufacturing in newly certified clean environments.Managed calibration contractors servicing and documenting over 1300 pieces of equipment to cGMP level.Direct management of 1 associate, in addition to management of contractors, to ensure equipment performance.Gathered data and reported performance indicators of packaging and filling processes using statistical techniques.Specified and installed capital projects in excess of $700,000, including filling, labeling, and packaging equipment.

Indianapolis, Indiana Area

-Developed and implemented program to reduce cost of goods by $342,000 annually.-Utilized statistical methods to develop automation best practices in a packaging environment.-Participated as founding member of employee continuous improvement team, saving $30k in the first six months.-Managed project to transform packaging department’s work techniques and add automation with $140,000 budget.-Developed and performed business-critical equipment validations.-Performed Failure Mode Effects Analysis within an FDA regulated environment.

Indianapolis, Indiana Area

Implemented ergonomic corrective actions to reduce injury risk in clean room environment.Prepared specifications, negotiated with vendors, and performed analysis for machinery with $60,000 budget. Performed project leader duties to resolve high-value customer complaints on high volume product line.Executed time and motion studies to aid development of costing for specialized processes.

Columbus, Ohio Area

-Participated in process change activities, including trial support, fixture design, approvals, and process support.-Created standards for line-side delivery of specialized containers of assembly components.-Collected, archived, and analyzed data for inter-departmental project to improve supply chain efficiency.-Developed design documents requiring input, suggestions, and approvals from all levels of the department.-Gained manufacturing experience by performing processes on main assembly line.