Driven, collaborative manufacturing and quality leader with a career record of performance and success in operational transformation, site start-ups and expansions, team buildouts, and product launches.Widely accomplished, pharmaceutical manufacturing and quality leader, expert in integrating talent and systems into efficient, compliant, and innovative organizations. Insightful and results driven Senior Manufacturing Director with 20+ years’ experience in operations management, troubleshooting, and process improvement. Proficient in performance metric development, staff training, regulatory compliance, product launch coordination, laboratory operations, production expansion, major equipment qualification and implementation. Excel at project management, stakeholder engagement and interpersonal communication. Enthusiastic about developing talent and leading teams to deliver success for the organization.Accomplished senior manufacturing director with 25+ years of experience spanning quality and operations management, troubleshooting, and compliance systems for market-leading products.Hands-on, resourceful, and results-driven leader who establishes and tracks KPIs, implements effective staff training programs, readies sites for major launches, and spearheads expansions.SME in pharmaceutical manufacturing and packaging operations, with a holistic view of people, processes, and systems and an open-door approach to mentoring and knowledge sharingRelationship builder who gains respect among teams to instill strong cultures of collaboration and continuous improvement; focused on quality, safety, throughput, efficiency, and engagement.
-
Director/Sr. Director SpmoMylan Technologies, Inc. Mar 2018 - Nov 2023St Albans, Vermont, United StatesResponsible 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. -
Senior Director, Manufacturing OperationsMylan Technologies, Inc. Aug 2006 - Mar 2018St Albans, Vermont, United StatesResponsible 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.
-
Director, Pharmaceutical ManufacturingMylan Technologies, Inc. Jun 2002 - Aug 2006St Albans, Vermont, United StatesDirected 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.
-
Associate Director, QualityMylan Technologies, Inc. Aug 1998 - Jun 2002St Albans, Vermont, United StatesOversaw 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.
Mike Sturm Education Details
-
Chemistry -
Project Management -
Chemistry
Frequently Asked Questions about Mike Sturm
What is Mike Sturm's role at the current company?
Mike Sturm's current role is Senior Manufacturing Director | Pharmaceuticals | Process Improvement | New Product Launches | Production Support | Project Management | Problem Solving | Team Building | cGMP Compliance | Consulting.
What schools did Mike Sturm attend?
Mike Sturm attended Rochester Institute Of Technology, Cornell University, Rochester Institute Of Technology.
Not the Mike Sturm you were looking for?
-
1taylormarine.com3 +151877XXXXX
-
-
Mike Sturm
Pacifica, Ca8moxieusa.com, moxieusa.com, gmail.com, aol.com, digimarc.com, digimarc.com, goswift.ly, totango.com6 +165058XXXXX
-
Mike Sturm
Rockford, Il -
Mike Sturm
San Marcos, Tx3sanmarcostx.gov, sanmarcos-tx.net, ci.san-marcos.tx.us5 +151239XXXXX
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial