Mike Sturm Email & Phone Number

Fairfax, Vt, Us

St Albans, Vermont, United States

Responsible for the management of all of the site’s large cross-functional projects and programs. • Managed project lifecycle by preparing budgets, adhering to operational best practices, and developing performance metrics to ensure accountability and timely completion of site critical and cross-functional projects.• Spearheaded site Serialization/Aggregation efforts by securing alternate vendor to provide, install and qualify solution for 6 critical packaging lines, and complete work in 6 weeks or less on each line, and 5 months in advance of FDA mandated deadline.• Led Automation Roadmap projects by coordinating local site and corporate resources and ensuring data integrity standards to oversee implementation of company automation-based initiatives. • Managed project to decommission, close and sell pharmaceutical label plant and equipment by working directly with Production, QA, Supply Chain, Engineering, EH&S, Corporate Real Estate, and beat deadline and budget expectations with $2 million+ sale. • Selected by senior management to provide oversight for all site Operational Excellence activities including direct management for site OE lead, programs and projects. Led Kaizen events, Gemba walks and SIC meetings.

St Albans, Vermont, United States

Responsible for all production operations for 3 divisions for the Mylan Vermont facilities.• Managed direction of all manufacturing and packaging operations at MTI's St. Albans facility, including seven pharmaceutical functions and three component manufacturing functions by directing capital and expense budgets of up to $40 million and workforce and equipment resource responsibilities for departments totaling to greater than 200 employees on three to five shifts. • Ensured compliance with pharmaceutical cGMP's as well as ISO9002 certification for component group and led or co-led numerous FDA and MHRA inspections with no 483, critical, or major observations over 15+ years.• Led and/or oversaw initiatives to support Operational Excellence goals by including programs to increase yield by 3% – 5% across the board and reduce changeover times by 25% - 40%. • Drove site “Right First-Time” quality metric performance from 65% to 85+% by working with direct reports to develop “Drive the Pride” program to improve training and to lead the corporation in this metric. • Orchestrated the development and implementation of a product line based “focused factory” for a new product line with new equipment by reorganizing the department management, reassigning, and training supervision, establishing new shifts, arranging weekend coverage from QA, Maintenance, etc., and establishing supporting procedures in time for product launch.• Provided critical operations support to Process Development to meet clinical and submission and technical transfer schedules.

St Albans, Vermont, United States

Directed groups which manufactured and packaged all pharmaceutical products under cGMP conditions and systems, as well as Production Support group. • Led launch of key product that resulted in $500 million in annual revenue for corporation.• Full responsibility for a budget of greater than $20 million and resource responsibilities for a growing department of greater than 120 employees with 10 -12 direct reports. • Provided manufacturing/packaging input, design and validation review for major equipment purchases and facilities changes. • Provided production plans and overall project management for launches of new products and line extensions critical to the corporate bottom line. • Set a three-year strategic plan on an annual basis.

St Albans, Vermont, United States

Oversaw all Quality Assurance and Quality Control Operations for 3 Vermont divisions.• In addition to the QC Lab and Stability responsibilities, responsible for Quality Assurance departments supporting the Pharmaceutical, Medical Products, and Pharmaceutical Label Divisions. • Headed group which performed all audits, AQL testing, provided or coordinated all training, and assured compliance with FDA, cGMP, ISO, ICH and foreign regulatory agency requirements. • Company contact for FDA, MCA, and DEA. Full budget and resource responsibilities for a department of more than 50 employees. Provided the majority of CMC information for all submissions to FDA.

Associate'S Degree, Chemistry

Certificate, Project Management

Project Leadership

Associate Of Arts And Sciences - Aas, Chemistry