Project Manager Six Sigma

Mark Cupryk, MBA, MSc.

Summary

Dynamic GCP and GMP Compliance leader with project, program and portfolio

expertise in driving major implementations with talented teams. Focused on

value add activity using Lean Six Sigma in project management processes

from research to manufacturing in pharmaceutical and biotechnology.

Ensures global alignment of execution tactics to organizational strategy

for breakthrough results and innovation. Using customized metrics approach,

systematically manages projects and programs to ensure stakeholder's

requirements are monitored and controlled. Acts as a regulatory trusted

advisor with over 15 years of regulatory compliance project expertise.

Professional Experience

biovalorem (Indianapolis, IN)

Principal (April 2008- present)

V Program Manager for largest biobank in Midwest (Fairbanks Institute).

Drove set-up processes of the business using Lean Six Sigma tools and

techniques.

V Prepared, executed and reported GCP audits of multiple CRO, clinical

sites, and clinical laboratories.

V Prepared and delivered high impact GCPs training for multiple clients.

V Established portfolio and program management for multiple clinical

research studies and grants for Regenstrief/IUPUI. Calibrated

processes with ISBER and OPM3 standards to implement a high degree of

compliance along with recommended PMI best practices.

V Implemented SCRUM framework for bioinformatics team to execute agile

development of projects within short time frames.

V Prepared Intermediate Lean Six Sigma training program for ASQ.

V Established customized Clinical Compliance scoreboard based on Lean

Six Sigma and OPM3.

V Prepared and delivered detailed study for Blood and Tissue Product

Safety for FDA's CBER.

Invensys (Indianapolis, IN and Foxboro, MA)

General Manager (April 2003- April2008)

Global Business Leader of Invensys' Pharmaceutical Services (>25M). Manage

all aspects of P&L (marketing, sales, finance, human resources etc) for

dynamic team of 200 worldwide consultants in providing regulatory

compliance solutions.

V Sponsored and mentored over 25 Lean Six Sigma projects for the

business unit and direct customers. Managed 8 satellite offices

through mentoring of Operations Managers.

V Established financial model and strategy for turning around global

business line to a 10% OPBIT business unit focused on key core

offerings.

V Diversified customer base from monthly average of 10 customers to

current average of 100. Resulted in increased orders from 12 to 25M

over 3 years in new customer base. Established portfolio of programs

and projects for internal growth.

V Created a well aligned performance-based culture by establishing KPI

metrics in recruitment, hiring and coaching the team of 200

consultants and project managers as well as direction of support

shared functions.

V Revamped Project Management Office to diminish defective invoices from

16% to 1% to ensure flexible and efficient processes (Lean Six Sigma

driven) that are customer focused throughout the globe.

V Spearheaded training program that enabled talent to share knowledge

24/7 world wide instead of past dependency on key subject matter

experts.

V Acted as consultant in multiple regulatory projects

Director of US Operations (Dec 2001 - April 2003)

Established US operations (start-up) with P&L management based out of

Massachusetts with several satellite offices in Indiana, Philadelphia and

San Francisco.

V Achieved stellar growth from 3 to 40 consultants (0.6 to 8M in orders

with 14% profit) in less than 2 years in consulting services in

project management, engineering and validation in pharmaceuticals and

biotech industries. Coached and integrated the team while managing the

business unit.

V Established recruitment programs at local university and networked

with partners for high performer hiring. This accelerated hiring by

50% and ensured that we were bringing motivated talent to our team.

V Managed and sponsored DCS validation effort (12M) for Eli Lilly

product of the year facility. Provided 30% savings in execution by

Lean Six Sigma intervention.

V Established the accelerated strategy for preparation of WBS, estimate,

and scheduling.

ALCAN (Montreal, Quebec)

GreenField Project Manager (2000-2001)

Lead implementation of world class, Greenfield pharmaceutical contract

manufacturing and packaging facility in Pennsylvania, USA (> US$40

Million).

V Managed successful integration of project including site selection,

permitting, and various disciplines of engineering, construction,

information technologies, organizational structure, training,

validation, communication and startup.

V Coordinated transfer of an existing liquid filling operation from a

New Jersey plant into new facility.

V Directed all engineering aspects of new facility as well as

presentation to the FDA, FM, and DEA to ensure compliant and safe

design.

V Led bid process for all consultants/contractors for conceptual,

design, construction and validation phases.

V Negotiated estimated savings of $2-3M through partnering and design

build value engineering.

MERCK (Montreal, Quebec)

Manager (1997-2000)

Managed system development life cycle for major renovation project ($100M)

as well as operational systems and equipment (Solid Oral Dosage).

V Responsible for regulatory compliance for all existing manufacturing

equipment, packaging lines and utility systems.

V Established enhancements to change control program leading to annual

savings of $300K.

V Supported improvements in performance monitoring and atypical

processes.

V Mentored and trained Merck staff and contractor resources.

Walsh Automation Inc (Montreal, Quebec):

System Consultant at MERCK, Montreal, Quebec ( 1996-1997)

Responsible for audits of computerized systems to determine risk in

regulatory compliance and follow through of corrective actions. Reduced

internal risk to corporate requirements and enabled successful FDA

inspection.

Site Construction Manager at AASSANA, La Paz, Bolivia (1995-1996)

Managed and mentored a team in the design/procurement (in Canada) and the

construction (in Bolivia) for high technology state of the art security

systems at the two major Bolivian Airports. (>$25M)

V Increased project gross margin to 40%.

V Security scope included video cameras, access cards, intercom system

and x-ray machines with a centralized security control center.

Communication included microwave and fiber optics.

Project Manager at BIOCINE, Siena, Italy (1994-1995)

Managed an Italian team consisting of fifteen engineers to prepare PFDs,

P&IDs, Isometrics and location diagrams for four pharmaceutical

manufacturing facilities (mainly vaccines- hepatitis, tetanus, yellow

fever) for a successfulFDA pre-approval inspection. Received letter of

recommendation for performance excellence.

Project Manager at SHELL, Montreal, Quebec (1994-1995)

Led the first in kind design, procurement, installation, commissioning, and

start-up of a retrofitted Hydrogen Compressor with Hoerbigger (Austria)

cost efficient control valves.

.

Scope Manager/ Project Engineer at DELTA BIOTECHNOLOGY, Nottingham,

England (1992-1994)

Managed civil, piping, electrical, instrumentation, site installations and

procurement of project. Involved from estimation phase to final start-up

into production of artificial Albumin facility.

V Controlled scope and maintained fixed cost project profitability above

15%.

V Managed procurement, installation, commissioning and validation

activities.

Automation Consultant at PETRO CANADA, Montreal, Quebec (1990-1992)

Served as key member in specialized automation team to relocate two control

rooms (Hydrogen production and Aromatics division) and implement

Distributed Control System technology to replace existing controllers.

V Site supervision and detailed Engineering consisted of preparing all

required engineering drawings, i.e. power and instrumentation, as well as

coordinating twenty electricians for successful installations under

budget and on schedule.

Production Manager at Performance Chemicals Ltd., London, England (1989-

1990)

Responsible for the production of industrial solvent, detergent, and paint

products. Managed operations, procurement of raw materials, control of

inventory, and distribution of products to all European destinations.

EDUCATION

Doctor of Business Administration (DBA) In Progress

University of Management and Technology, Arlington, VA

Master in Project Management (MSc.) 2003-2005

University of Management and Technology, Arlington, VA

Executive Master in Business Administration (EMBA) 1997-1999

Executive program, Concordia University, Montr al, Qu bec

(Accredited by the American Assembly of Collegiate Schools of Business)

Bachelor of Chemical Engineering (B.Eng) 1984-1987

McGill University, Montr al, Qu bec

CERTIFICATIONS

Master Black Belt Certified (SixSigmaUS) 2006-2007 (Multiple Sessions)

Black Belt (ASQ Certified) March 2008

Black Belt (Invensys Certified) June 2005

Green Belt (Invensys Certified) July 2004

OPM3 Certified Consultant) In Progress

Project Management Institute (PMI), Pennsylvania, USA

Project Management Professional Certified (PMP) 1998

Project Management Institute (PMI), Pennsylvania, USA

Sales Advantage

(Dale Carnegie)

Leadership Training

(Invensys)

Negotiations

(Karass and Invensys)

Stephen Covey - 7 Habits of Effective People

(Merck)

Instrument Society of America (ISA) Certified:

Measuring Process Variables (1991)

Automating the Process/Design Practice 1 (1992)

Industrial Process Control/Automation (1991)

Automating the Process/Design Practice 2 (1992)

Languages (written/spoken)

Fluent: English, French

Basic: Spanish, Romanian

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