Sr Project Manager

DAVID GROSSMAN

Phone: 706-***-**** E-Mail: *****@*******.***

SUMMARY

PROJECT and PROCESS ENGINEERING MANAGER

Strategic planning and flawless execution combine to produce engineered

solutions that generate growth, increase profitability and launch new

product platforms.

Results driven Manager with extensive Engineering experience in the

dynamic, Medical Device environment. Recognized for taking strategies,

conceptual ideas and prototypes to developing and deploying infrastructure

and manufacturing systems that meet growth and sustainability objectives.

Strategic focus and a broad technical knowledge create solutions that are

stable, reproducible and qualified to meet Corporate Objectives and FDA

Regulations. Adept at working cross functionally to incorporate Marketing,

Finance, R&D, IT, Quality, Safety and Production Goals into deliverables;

deployed on-time, within budget. A trusted leader with an impressive track

record of managing dedicated teams that deliver bottom line results and

take pride in ownership. Articulate communicator and skilled negotiator

with a history of integrity and dependability. Areas of expertise include:

Project management, timelines, budget, Leadership, cross functional teams,

reports International

Communications, written, verbal, Process design, implementation,

presentation improvement

FDA, cGMP, Validation, IQ, OQ, PQ, CSV 3rd party vendor selection, negotiation,

Six Sigma, 5S, DOE, LEAN methodologies control

Facility layout, construction,

renovation

CAREER HIGHLIGHTS:

Project Management / Direction / Integration

. Managed complex, high impact projects that built core Manufacturing and

Distribution capacity resulting in marketplace dominance and sustainable

growth within the sector.

. Executed projects that boosted lens Manufacturing output to 2,000,000

units per day, Distribution shipments to 10,000 orders per day. Generated

ongoing savings in excess of $8M per year. Provided platforms that

supported growing business objectives.

Process Development / Design / Transfer

. Designed, transferred, scaled up and deployed strategic process

technologies which drove new lens product launches, generated more than

$200 million additional sales volume and established leadership in

marketplace position.

. Qualified all processes to meet Corporate and FDA governmental

requirements for regulatory, quality, compliance, safety and production

criteria.

Leadership / Accountability / Trust

. Selected to lead or co-lead high visibility project teams to execute

critical corporate initiatives within strict timeline and budget

constraints. Project values range from $250K to $25 million, typically

spanning a multi-year planning, development and execution cycle.

. Skilled at leading cross functional teams that operate transparently,

demonstrate accountability, have minimal conflict and achieve objectives

per plan with ongoing productive relationships.

. Trusted to maintain confidentiality and discretion while developing

production capacity requirements, staffing scenarios, budget formulation,

timelines, vendor negotiations, proposals, contract reviews and

approvals.

DAVID GROSSMAN

PROFESSIONAL EXPERIENCE

In Home Care Giver - Work Sabbatical, Ellijay, GA 2013 - Present

Took a work sabbatical to care for an elderly parent. It was a time of

understanding, insight and fun together.

At age 96, she passed. We were not surprised, however it was a time we

wished would never come.

Although a sad event, I am now refreshed, excited, and ready to perform as

a Senior Level Manager.

I look forward to being a productive member of your team, collaborative and

with an optimistic outlook.

EndoChoice, Roswell, GA 2013 - 2013

Full service provider of endoscope instrumentation, consumables and

Pathology services, specializing in the gastrointestinal marketplace.

Recent scope technology acquisition generated significant growth in the

organization.

Reporting to the Chief Operating Officer as the Sr. Project Manager,

provided facility planning, expansion design and day to day management of

critical facility services.

. Responsible for development, design and upgrade of new Pathology

Laboratory, providing specialized ventilation, fume hoods, electrical

infrastructure, lab furniture, office furniture and support areas for lab

staff and Pathologists. Managed the design, construction, renovation,

purchasing and installation of lab equipment and furniture for the

process expansion. Capacity capability exceeded projections, providing a

stable platform to grow without additional capital or labor expense.

. Developed facility requirements for expansion of Sales and Manufacturing

Operations in Israel and Germany, providing space estimates, 5 year

projections and interactive worksheets to assist local management teams

working with architects and real estate brokers to find suitable

facilities for expansion space.

. Managed day to day facility operations for Headquarters and Pathology

lab, providing housekeeping, janitorial, food services, HVAC, electrical

and office / cubicle renovation to support high numbers of new employees

joining the company. Coordinated with IT, department heads and suppliers

for minimal impact on personnel.

OPTI Medical Corporation, Roswell, GA (Division of IDEXX Laboratories)

2010 - 2012

Manufacturer of instruments and consumables to perform rapid blood gas and

electrolyte analysis

for the human and veterinary markets.

Reporting to the VP of Regulatory Affairs as the Sr. Project Manager,

accountable for capital budget development, project management, staffing,

process transfer, validation, approvals and start up of the calibration

process.

. Responsible for transferring Species Calibration Process from IDEXX

Laboratories, Portland, MA to OPTI Medical in Roswell, GA.

. Developed scope, project plan, capital budget and staffing plan. Hired

staff, created laboratory layouts, contracted construction, outfitted lab

with specialty freezers, analytical equipment, safety devices, utilities,

electrical and data infrastructure to support process deployment.

. Led team which partnered with Scientists, Researchers and Data Analysts

at both sites, gaining the trust and support of the transferring and

receiving parties. These relationships were key to Management at both

locations as the strategy involved substantial product growth,

constrained timeframes, cost saving commitments and quality objectives,

which could not be compromised.

. Process transferred on time, within budget and was fully validated to FDA

requirements. The staff performed above expectations and realized $250K

in calibration labor savings per year. More importantly, the staff at

IDEXX could focus on breakthrough technologies rather than performing

routine calibrations.

DAVID GROSSMAN

CIBA VISION CORPORATION, (A Novartis Corporation) Duluth, GA 1982 - 2010

Industry leader in soft contact lenses and contact lens cleaning solutions.

Manager, Process Engineering 2008 - 2010

North America Lens Distribution Center

Reporting to the Head of US Logistics, accountable for capital project

budgets, project management results, reporting, process improvement,

technology application, bid negotiation, employee reviews.

Warehouse Management System (WMS) Design / Deployment:

. Led team that researched, specified, selected and validated a new

Warehouse Management System (WMS) for the Distribution Center.

. Achieved objective to deploy a validated, top tier WMS software platform

(Red Prairie), to improve operational efficiency, increase flexibility,

replace aging infrastructure and provide a model for use in future

installations worldwide.

Lead Engineer, Process Manager 1998 - 2008

Led cross functional team with IT, Production and Procurement to select,

negotiate, engineer, deploy, start up and validate an automated

distribution system with a capacity of over 10,000 orders/day, 80,000

SKU's, A-Frame, V-Frame, OSR picking technologies with associated

conveyors, interfaces, controls and IT infrastructure. Responsible for the

design, development and phased deployment of the Knapp automated system to

pick, pack and ship contact lenses and related products.

Distribution Center Automation:

. Created ongoing savings in excess of $8 million per year through

headcount reduction of 200 employees, elimination of 3rd shift operations

and freight optimization. System provides consistent, on-time delivery

of customer orders at service levels previously unattainable by the

organization.

. Attained objective for system design to be the model for expanding into a

worldwide distribution strategy, providing a known performance and

reliability platform to mitigate risk and time to market of future

installations.

Professional Lead Engineer 1995 - 1998

Co-Led project that expanded into a 24/7 manufacturing facility employing

600+ people with production output of over 1 billion lenses per year. This

high capacity platform launched the Daily and Monthly disposable contact

lens products worldwide and established CIBA Vision as the top tier

provider in these lens categories. Held overall responsibility for assuring

process machinery, infrastructure and support systems were understood,

documented and would transfer and scale up from Germany facility to newly

built manufacturing site in USA. Infrastructure installed, process

transferred and scaled up per plan, providing $200M product platform sales

and expansion space.

Senior Project Engineer 1993 - 1995

Responsible for design, capital budget, vendor selection, contract

negotiation, project management, progress reports, technology selection,

reviews and approvals. Project Manager and system designer to create lens

hydration and extraction systems for removal of impurities and soften

contact lenses prior to final packaging steps. System designed and built

for handling flammable liquids with mixing, metering, distillation,

purification and recycling operations incorporated with explosion proof

operator stations and controls. Fully Validated to FDA regulations.

Manager, Implementation Engineering 1988 - 1993

Managed the transfer and scale up of acquired manufacturing technology for

the injection molding, casting and UV curing of contact lenses from 3

different companies. Reported to the Vice President of Manufacturing,

responsible for technology evaluation, employee selection, capital budget,

project management, scale up, engineering design, results reporting,

validation and start up of Production Modules.

ADDITIONAL PROFESSIONAL EXPERIENCE

CIBA VISION CORPORATION,

Electrical Engineer, Equipment Services Technician

MICHIGAN STATE UNIVERSITY (Biochemistry Department) East Lansing, MI

Biomedical Instrument Technician

Campus Instrument shop supporting scientific research with equipment

design, modification and repair.

Responsible for developing new, and keeping existing research and

scientific laboratory instrumentation in working order to insure

experiments are performed accurately and on schedule with research grant

requirements

EDUCATION

Associates Degree, Electronics Engineering

Lansing Community College, East Lansing, Michigan

Magna Cum Laude Graduate

PROFESSIONAL DEVELOPMENT

Project Management for Technical Projects, Project Management for IT

Projects, Financial Management for Non-Financial Managers, IQP Silver Belt

(Novartis sponsored Six Sigma Program), ICE Validation Methodology (V-

Model, GAMP), Workplace Ergonomics - A Practical Approach, AGILE software

development

SPECIAL SKILLS

RedPrairie Warehouse Management System (WMS) deployment and operation,

Knapp Logistics and Automation, Klass-X, I-Point (WCS) deployment and

operation.

Contact this candidate