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505-207-7740

U.S. Cit / Currently NJ / not available for relocation
BS Chem Eng.
Oral solid dose, Oral thin film, ORAL Solutions, Ointments, Powders, Liquids, Creams, Transdermal patches, APIs and Lipbalm manufacturing and packaging, including potent compounds and controlled substances
P&L Ownership| Strategy Development & Deployment| Culture Transformation| GMP Requirements & Culture |Leadership |High Performance Teams| Productivity Improvement Strategies | TPM | 5S | OEE| Project Management | Program Management | Global and Multifunctional Team Leadership

Accomplished Rx pharmaceutical, generic, and fast-moving consumer products supply leader, including organizations of up to 650 people. Full financial and customer service accountability of operating budgets up to $70 million and 170 million units. Demonstrated track record of leading high-growth operations, operational excellence improvement, and cultural transformation. Hands on and management experience in contract manufacturing, quality assurance, validation, engineering, and technology transfer.

EDUCATION

B.S. Chemical Engineering with Distinction

Clarkson University (3.6/4.0), Potsdam, NY

Tau Beta Pi and Omega Chi Epsilon Honor Societies

Rotary International Exchange Student (South Africa)
Experience

March 2018-December 2020: Site General Manager

Responsible for overall site leadership including formulation development, analytical laboratories, and clinical and commercial supply. This site is the east coast center of excellence for controlled and modified release formulation development as well as hot melt extrusion technology, highly potent drugs, and DEA schedule I-V controlled substances.

Defined and led implementation of new site strategy that in two years: doubled site revenue and improved site profitability from negative to approx. $20 MM.
Assured no stock-outs when demand exceeded 3.5 times forecast on a capacity constrained line.
Doubled capacity on key work center via Kaizen improvements.
Launched 5 new products, requiring headcount increase of 40% to support.
Executed multiple successful regulatory inspections: FDA ( no 483’s), ANVISA (Certificate Issued), as well as Turkish and Japanese agencies and multiple customer audits with no critical observations.
Reduced Overdue Trackwise documents by 300% to single digit levels.
Revamped site leadership team to support rapid growth and performance trajectory

June 2014 – February 2018: Site General Manager

Overall site leadership of the generic, solid-dose, manufacturing location in Middlesex, NJ. Recruited as the Sr. Director of Operations for CorePharma in June 2014, and promoted to General Manager upon the purchase of CorePharma by Impax in March 2015.

Led the site to become the highest performing site in the network.
Delivered 10 product launches and transferred 38+ packaging sku’s into the site over a two year period.

Reduced conversion cost by 18%, while improving customer service from 84% to 98% line fill rate.
Completed 3 successful FDA inspections, including 4 PAIs, with no observations.
Completed 2 DEA inspections, 1 OSHA inspection, and numerous NJDEP inspections with no findings.
Improved Quality Investigations Completed On Time from 42% to 98%.
Safety TIR maintained at ≤ 1.6.

March 2010 – May 2014: Vice President – Production Operations

Led all aspects of production operations for a niche technology contract manufacturing and development site of approximately 250 employees across three shifts. Served seven major clients with sales of approximately $200 MM across 50 skus.

Led the implementation of OEE and several lean-based initiatives across the site resulting in $1.1MM in annual savings.
Saved one client company over $600K per year in API costs by reducing yield losses by 60%.
Saved $600K per year in inspection costs by eliminating a major quality defect.
Saved $120K per year in disposal by validating new cleaning procedures which reduced solvent usage by 60% on one product line; and implementing solvent recycling.
Delivered three new products to the market including one completely new technology.
Drove safety results from 1.4 Total Incident Rate to 0.0 including one year injury free, and the accumulation of 1MM safe work hours.

August 2008 – December 2010: Director Third Party Operations, Americas

Delivered service, cost and quality across a spend of approximately $100 MM across 600 skus and 60 third party manufacturing sites in North America, and Latin America.

Developed Supplier Management Operating Rhythm, Scorecard, and Procedures to drive superior service and cost of goods.
Contributed significantly to record breaking $20 MM cost savings results in Global Third Party Operations, via KPI reviews, ideation tools, and negotiated price reductions.
Delivered unprecedented $20 MM in cost savings in Global Third Party Operations via: KPI reviews, negotiated savings, and ideation tools.

April 2005 – August 2008: Site Leader

Led all aspects of production operations of a large manufacturing and development site of over 550 employees across three shifts. Production included multiple dose forms and packaging configurations across OTC, Rx, and Animal Health Businesses.

Grew plant volume by 60% overall, via site transfer of volume on time, in budget, and with no service outages.
Extended plant supply capability from regional to global.
Delivered cost improvements ranging from $7-10 million per year.
Increased OEE from 32% to 60%, and Customer Service from 94% to 99%.
Compliance excellence in all areas: FDA, DEA, SOX, EHS etc.

September 2003 – April 2005: Senior Director, Topicals Primary Processing Unit

Led all aspects of production operations for solid dose and topical OTC production at Richmond site. Managed an organization of over 250 people across 3 shifts.

Increased schedule attainment from 72% to 98%, while increasing overall OEE by 20%.
Delivered 400% productivity increase in ChapStick packaging operation.
Maintained customer service at 98% in an environment of 50% average forecast variation.

March 2000- August 2003

Site Quality Assurance Manager – Hair Care

Responsible for all aspect of the quality systems program at Iowa City plant including: GMP compliance, validation, QA/QC, microbiological lab, product release, quality tracking, and auditing. This is a large, high-volume (100M stat per year) site.

Led integration of quality systems associated with new acquisition including: 85 new raw materials, 25 new suppliers, 100 new skus, and 65 new formulae, in 6 months. Completed over 150 validation protocols and reports.
Led implementation of an SAP solution designed specifically for regulated products.
Saved over $1.0 million in cash and $350,000 in yearly hiring avoidance costs via implementation of ATP bioluminescence test method. This method was re-applied to all hair care manufacturing sites with additional savings.
Saved $1.8 million through development of reduced product washout strategy and capability.
Reduced quality incidents by 50% and incurred zero significant quality incidents.

Oral Rinse Business Leader

Led the North America Oral Rinse business at the site level including: cost/budget, production reliability, customer service, inventory, and capital projects. Key liaison between the plant and corporate hierarchy. Manage 5 direct reports and a budget of $6.6MM.

Reduced manufacturing expense by 10%, surpassing best price offer of private label contractor.
Delivered customer service of 99.9% orders shipped complete.
Reduced inventory by $1.2 million cash value (13 days on hand) via produce-to-demand strategy implementation.

May 1988- March 2000: Chemical Operations and Global Initiative Program Manager

Managed all aspects of a 3 shift bulk drug substance operation including 3 direct reports, and 50 operating technicians. Additionally responsible for global launch of a major new drug initiative.

Delivered 180% of forecasted volume shipments on time with flat budget, reducing standard cost by 30%.
Developed and implemented global plan to deliver new drug to market in a record 14 days post FDA approved versus 14 – 16 weeks historical timing. Generated $1million each day of additional time on the market.

Multiple additional roles of increasing responsibility including:

Site TPM/Process Reliability/Chemical Department Manager

New Drug Initiative Start-Up Manager

Ethical Chemical Team Manager/Process Engineer-

FOR FULL RESUME: Call 505-207-7740 or email jobs@pharmaboard.com