MICHAEL BRACCO

*** ********* *****, ********** **

219-***-**** acpuun@r.postjobfree.com

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

Contact this candidate