MICHAEL BRACCO
*** ********* *****, ********** **
219-***-**** **********@*******.***
Manufacturing and Operations Executive
Summary
A self-motivated, competent and highly versatile operations leader with 29 years of progressive
pharmaceutical experience in all aspects of site operations. “Hands-on” leadership approach highly
focused on accountability and outcomes. Solid management and people-skills focused on hiring and
developing strong teams. This approach combined with savvy business acumen has provided the
foundation for progressive roles within fast paced, highly challenging and diverse work environments.
KEY SKILLS
Strategic and operational business partner with experience in diverse, multi-cultural and global business
environments including Thin Film, Transdermal, liquid, and solid-dose pharmaceutical manufacturing
industries.
• Ability to successfully manage in a matrix environment and to influence / lead across a diverse,
multicultural environment.
• Demonstrated ability to drive major initiatives through the organization and influence decision
makers at all levels.
• Results oriented delivering high yields of quality product and reducing scrap and production
downtime.
• Solid understanding of the cGMPs and their application to daily operations.
• Ability to effectively manage projects, including developing objectives, prioritizing
responsibilities, delegating tasks, executing project deliverables, and tracking and measuring to
successful completion.
• Strong situational, organizational, strategic and creative leadership capabilities.
Experiences
MonoSol RX – Portage Indiana (01/2011 to 05/2015)
SR. Director of Operations
Leading a team of 7 direct and 2 indirect reports and 150 employees in a 24/7 Operation producing 250 million dosages
of Thin Film Pharmaceutical products. Primary focus included orienting the site to improve accountability, efficiencies
and reduce deviation and Non conformances.
• Successfully completed several FDA inspections with no major observations
• Successfully staffed and started up an additional Packaging operation in a second site
• Second site located a mile away from original site in Portage Indiana
• Increased supply chain to customer from 2 weeks to 4 to 5 months of inventory
• Increased shipped on time to over 90% for the past two years
• Increasing supply chain was a direct result of focus on the system and reducing the batched that were held up
in Deviations and Investigations
• Successfully completed several DEA audits across multiple sites
• First company in the Newark DEA district to get approval to handle Schedule III controlled drugs in a “Comingled”
space
• Increased yield from 60% to a current of 86% overall
• The increase in yield was recognized after I re-align Responsibility, Accountability, and Ownership of critical
equipment. As well as leading culture change for the entire site on the fact that this was a “Production Facility”
and all activities were to support it.
• Implemented corporate EH&S personnel to provide safety programs consistently across all sites.
Operations
• Managed 130 person Manufacturing and Packaging team across two sites
• Took Site from 50 million capacity output to 300 Million capacity out with no capital expenditure
• Reduced scrap from 35% to under 10%
• Reduced through put time in Packaging from 92 hour to 42 hour with higher yield
• Production planning and scheduling
• Site Administration
DEA
• Set DEA strategy and policy for the entire corporation
• Developed the ability to handle Schedule II through Schedule V in all facilities
EHS
• Developed programs and coverage across all three facilities
• Developed compliance programs for water and other areas
Supply Chain
• Led a team of 3 individuals setting policy for a material management strategy for MonoSol Rx
• Sourcing and developing relationships to support R & D activities
• Oversight for purchasing
NBTY Solgar Vitamin and Herb – Ronkonkoma, NY (2008-2009)
Managing Director, Physiologics
Took on a newly formed position that transferred all production of a 250 SKU product line to a site with available
capacity. Re-designed / Re-branded and re-launched a direct sell line of nutraceuticals marketed solely to health care
professionals. Developed and initiated new product marketing strategies. Developed the entire team including sales
force.
• Changed the entire look and feel of the “Physiologics” line from Institutional white plastic to cobalt blue glass
and silver metal embossed caps
• Developed job descriptions for all necessary staffing
• Hired all marketing roles as well as entire sales force.
• Line out grew the plant’s capacity and had to transfer a second time
Lohmann Therapy System – West Caldwell, NJ (2005 to 2008)
Director of Packaging and Converting
Lead a team of 4 managers and 3 Supervisors focused on the quality manufacturing and converting of Transdermal
patches both controlled drug and standard Pharmaceuticals application. Developed the strategies to package product
in thin film platform.
• 3 Successful launches of new products
• Became the liaison to the customer on all new products
• Instrumental in developing inspection technology to salvage $3mil of product
Wyeth Solgar Vitamins and Herb - Leonia, NJ (2001 – 2005)
Assistant Director, Packaging and Labeling 2004 to 2005
Senior Manager, Packaging and Labeling 2003 to 2004
Manager, Packaging 2002 to 2003
Supervisor, Packaging 2001 to 2002
Managed a team 7 direct reports and a 70 person Solid Dosage Packaging Operation, Graphic Arts Department,
Inhouse Label Printing Operation and Label Control Room. Had functional responsibility for Mechanical and
Engineering staff for the entire Lyndhurst, NJ facility.
• Received the first Wyeth issued Global excellence award for In-House printing operation
• Developed a non-GMP nutraceutical Packaging operation and transitioned it into a Wyeth cGMP packaging
facility
• Increased scheduled adherence from 70% to 93%
Rockland ARC – Congers, NY (1999 – 2001)
Plant Manager
Lead team of 11 direct reports that managed the oversight of a 175-person operation that was focused on packaging
and food preparation and consisted of mentally and physically handicapped (and non-handicapped) individuals.
• Designed and developed Apparatus to allow handicapped individuals to do repetitive tasks to earn income
• Doubled the average individual income year over year
P.F. LABORATORIES – Totowa, NJ (1998 - 1999)
Technical Advisor, Packaging
Provided oversight for a solid dose narcotic packaging operation with 2 direct reports
• Validation of an automated Uhlmann Blister Packaging line.
• High level of accountability and accuracy of controlled drugs
Novartis Pharmaceuticals/Ciba-Geigy – Suffern, NY (1988-1997)
Senior Supervisor II, Warehouse/Packaging Supplies 1994 to 1997
Senior Supervisor II, Granulation/Pharmaceutical Manufacturing 1993 to 1994
Senior Supervisor II, Production Services 1992 to 1993
Senior Supervisor I, Dispensing and Warehouse Services 1991 to 1992
Section Supervisor, Dispensing 1988 to 1991
Held positions of increasing responsibility providing direct oversight for all facets of Pharmaceutical production.
• Designed and implemented the use of an off-site warehouse consisting of 3 buildings and 40,000 sq ft.
• Traveled Europe to help set design of Dispensing operation
• Develop procedure to allow schedule III & IV controlled drugs to be stored in automated warehouse
EDUCATION
B.S. Marketing, ST. Thomas Aquinas College
M.B.A., Management, Iona College
References supplied upon request