Mike Lipke Email & Phone Number

Indianapolis, In, Us

Dallas, Tx, Us

Senior Director of Operations (Eli Lilly Account)

Dallas, Tx, Us

Dallas, Tx, Us

Global Sr. Director of the Central Services Operations organization across multiple business units for CBRE as a service partner to GSK global facilities. Responsible to design and implement facility maintenance management programs for portfolio of properties, balancing client priorities in the areas of cost, business and operational risk.• Manages account programs aimed to ensure safety and compliance with national, state and local codes and regulations. Examples include fire and life safety, environmental, or industry/client specific third-party compliance standards such as JCAHO, ISO 14001, cGMP, etc. • Develops operational service delivery solutions to include documented playbooks, account operations plan, etc. Monitors effectiveness of maintenance efforts for facilities as assigned, ensuring work is completed in accordance with account KPI’s (Key Performance Indicators). • Responsible for client account inspections of all facilities. Documents inspection report results and rectifies any issues, concerns, etc. with client. Oversees account site operations and new projects. Identifies capital improvement projects and conducts cost analysis utilization in preparation of capital budgets. Travels to location for projects management issues, concerns, etc. • Evaluates outsource provider "hard services" contracts to ensure best pricing and service level performance. Coordinates RFP process through client and sourcing groups. • Responsible for development and training to all field and management staff in areas of operational and technical requirements on a client account which includes service performance, technology, safety and compliance, cost savings initiatives, and regulatory requirements.

Dallas, Tx, Us

Under general direction, represents the primary relationship between Client Quality representatives and CBRE. Responsible for the development and implementation of the GWS (Global Workplace Solutions) SRFS (SPECIALTY & REGULATED FACILITY SOLUTIONS) Quality Management System managing the alignment to the clients Teams and CBRE Corporate Quality Management Systems. Tracks and measures LS client team Audits and following investigation / action plans assuring services appropriate to the Life Sciences market. Evaluates, selects, implements and actualizes Best Practices across the Life Science portfolio. Provides understanding and use of the customer satisfaction assessment process, the integration and reporting of on-going process measurements, and control plans. Oversees Client team CAPA / QI events for CBRE deliverables as well as provide consultation and direct line management for Client Site Team Quality Mangers / Directors.

Indianapolis, Indiana, Us

Led the Operations, Quality, Science and Engineering functions for Research Models division of Envigo, and serve as a member of Executive Leadership Team for company. • Led organization of 1200+ employees across 15 global sites (US, Europe, UK and India). Direct reports include team of 8 Directors in global organization across multiple geographies (North America, Europe, UK, India). Responsible for Operations budget of over $120M. • Led the implementation of new business processes in all areas of responsibility including Quality Management Systems (Deviation Management, Customer Audits, Validation), Regulatory Compliance, Capital Planning/Execution of Capital Projects and Engineering and Maintenance for global division of over $200 million in annual revenue.• Served as Senior Executive Sponsor for project to design and build new Production Facility in Livermore California and Hyderabad, India (investment of $4M) to serve new markets. Facilities represent best in class processes and facility design.• Drastic improvement in Quality results including 25% reduction in customer complaints, 100% improvement in successful customer audits leading to increased revenue.• Led the implementation of global Biosecurity program focused on standard processes and procedures executed via gap assessment and action plans at the Site level. • Implemented measures to reduce operational cost of global Operations by over $3.5 million annually. Results due to productivity and cost improvements through implementation of Lean Six Sigma (global effort started under my leadership leading to elimination of process waste in model production).• Developed and implemented global strategy to change the Site Network footprint resulting in an annualized Operating savings of over $5M for the company. Program involves detailed financial and production planning analysis resulting in strategy.• Completed implementation of global Employee training program.

Indianapolis, In, Us

Served as HR Head for 1800 person division of Harlan, including global responsibilities for full HR function, with direct reports in US and Europe. Responsibilities include: Talent Management, (Recruitment, Succession Mgmt, High Potential Development), and serving as Strategic HR Business Parter for Mgmt Lead Team of RMS Division

Switzerland 🇨🇭 , Ch

- HR Business Partner for 1800 person RDO unit in Indianapolis. Managed team of HR Managers. Responsible for Talent Management services and processes for Roche Diagnostics Operations unit of approximately 2,000 employees at Indianapolis location. - Talent Management includes HR Business Partners, Recruiting, Global Mobility, Domestic Relocation, Succession Management processes, and High Potential Talent development.- Served as Process Owner for Performance Management and Succession and Talent Management- Led a team of 9 people, including 4 Managers (HRBPs and Global Mobility Manager).- Implemented leadership talent assessment - Implemented Talent Acquisition strategy currently being implemented includes hiring manager training and service level agreements, comprehensive metrics package to assess success, and university recruitment and intern program. Strategy implementation has reduced time to fill and open positions by over 50% in 1 year, while hiring 10 new college graduates and 40+ interns from targeted universities.- Served as leader of Change Management team responsible for global SAP HRIS system implementation at local site. System launch complete and successful.- Developed and implemented long term OD strategy for global RPD Clinical Trials and Regulatory Affairs in partnership with global leadership team. Initiatives include implementation of global learning intervention related to Regulatory Affairs, rotational assignments program and new product training.

Indianapolis, Indiana, Us

• Responsible for Leadership Development for global Mfg and Quality organization (all leadership levels, all manufacturing sites worldwide including 2,500+ leaders) including strategy and execution.• Major contributions include development and total ownership of comprehensive program of competency models, assessments, and training and development programs and events. Events range from basic leadership skills training to experiential “action learning” programs for high potential employees to executive development and coaching. Role includes program development and instruction, and executive coaching/consulting.• Responsible for Training and Development organization of worldwide Parenteral (Injectable) manufacturing network (6 plants, 6,000+ employees) including strategy and execution.• Major Contributions include project manager and building owner of Mfg and Quality Learning Center (MQLC). MQLC is a $10+ million, 71,000 sq. ft., facility designed as hands-on simulation training and onboarding center for Mfg and Quality employees. Center seen as “best practice” by FDA, and used for training FDA investigators.• Responsible for implementation of employee qualification strategy/programs and technical education for Quality, Operations and support personnel. Built comprehensive Parenteral technical education program, now implemented globally.

Indianapolis, Indiana, Us

• Responsible for Managing Aseptic Insulin Filling group of over 130 employees. Organization produces injectable Insulin products for the worldwide market in Aseptic filling environment.• Experience in dealing with the FDA as representative for area. Lead cross-functional process team for area, including membership from Operations, Quality, Engineering and Technical Services.

Indianapolis, Indiana, Us

• Human Resources Business Partner responsibilities for Parenteral Manufacturing Site of 650+ employees including hiring, succession planning/talent assessment, salary administration and coaching of site leadership. Site personnel include Operations, Quality, Engineering and Technical Services.• Major contributions include establishing and conducting recruiting processes for hiring of 250+ new employees. Process included implementation of hiring simulation exercise used for pre-employment screening.• Also led Senior Human Resource Planning Team responsible for succession planning and talent assessment processes at Senior Management level.

Indianapolis, Indiana, Us

Shionogi Qualicaps is a $70M global supplier of custom empty hard shell capsules supplied to the Pharmaceutical, Generics and Vitamin market. Business acquired from Lilly and I was “on loan” to Shionogi through initial start-up of new plant site.• On behalf of Lilly, served as Plant Manager of start-up site of 150 person production, maintenance and support services operation. Plant revenue exceeded $35 million serving worldwide markets.

Indianapolis, Indiana, Us

Dept. Head, Capsule Manufacturing (1992 – 1994)Master Scheduler, Animal Health Manufacturing (1990 – 1992)Planner/Buyer, Clinton Manufacturing Site (1989 – 1990)Industrial Engineer, Plant Engineering, Clinton Manufacturing Site (1988 – 1989)