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Robert Half Management Resources Salaried Professional Services 1700 West Park Drive, Westborough, MA 01581 508-621-2300 [email protected] Seasoned international executive with over 20 years of public and private experience in Finance Planning & Analysis with cGMP/cGXP experience in Research and Development, Laboratories, Manufacturing and Bio Pharma IT. Verifiable success creating and delivering outstanding FP&A and capital solutions using SAP, Oracle, Hyperian and other packages for small divisions of $50 million up to $25 billion group wide solutions. Talented in building commercial and financial solutions from the ground up, implementing SAP, training teams and providing solutions to Executive Teams. Proven abilities as a Finance Business Partner and adding value to operations. Excels as a transaction manager and finance professional. —————————— Key Examples of Success —————————— Deep Bio Pharma experience in designing, structuring and using FP&A systems and in making effective use of SAP hierarchies, Internal Orders, Settlements, Cost and Profit Centers, Business Objects and Hyperion. Extensive life cycle technology experience from upgrading legacy Biopharma ERP systems to SAP 4.0. Extensive lifecycle experience in Biopharma SAP 6.0 rollouts, new General Ledger and Biopharma Fixed Asset implementations and upgrades. At Shire, he held the highest authority level for capital approvals. Approved, structured and analyzed transactions. Built FP&A systems for all of the new $500+ million cGMP developments. —————————— Areas of Strength ——————————— Finance Business Partner Annual Budgeting Product Lifecycle Forecasting Capex Planning and Forecasts Long Range Planning Product/ Competitor Analysis SAP Super User Cash Flow Budgeting GAAP/IFRS & IRS Assumptions —————————— Skills and Experience ——————————— Areas of Specialization Research and Development Clinical Trials Laboratories Large Scale Development Laboratories Quality Control Contract Manufacturing Plant Manufacturing Supply Chain Technical Operations Bio Pharma IT Bio Pharma Tax and IRS Cost Segregations MLSC Grants Sunshine Act Royalty Calculations, Billings and Audits Medicaid and Medicare IT Projects from Concept to Deployment All Bio Pharma Capital Projects cGMP SAP Super User and Trainer Shopping Cart and Accrual Trainer Industry Experience All Stages of Clinical Trials Live Animal Research Orphan Drugs Cell Culture Bio Reactors Purification Vaccines Technology Expertise cGMP Qualified GAAP, IFRS, IRS, SOX, SEC SAP, SRM, Oracle, Hyperion DOA, Cockpits and Accrual Manager Blackline Organizations/Operations Served Shire Plc Alewife Cell Culture Plants 300 Shire Way Cell Culture 300 Shire Way QA and QC 200 Shire Way Laboratories 200 Shire Way LSDL 125 Spring St Research Operations 125 Spring Street Live Animal Division 400 Shire Way Cell Culture 400 Shire Way Manufacturing 700 Main Street Labs 700 Main Street LSDL Global IT Operations SAP Implementation Division SAP Upgrade Division North Reading Supply Chain Operations Kmart Target Coles and Bi-Lo Supermarkets Myer Department Stores Officeworks World 4 Kids Liquorland The Davis Companies Reit Management and Research LLC Arthur Andersen Transaction Services Education and Certifications CPA license Australia Chartered Secretary and Administrator London, UK Michael Irving, CPA Bio Pharma and FP&A- Management Consultant “Roll up the sleeves work ethic that builds loyalties with teams, executive boards and investors” SELECTED PROJECTS BIO PHARMA FP&A SYSTEMS, design, development, rectification, rollout and training. During the first 12 months he received recognition from the Group Audit Committee for implementing new FP&A systems and processes for the Lexington Campus. Later he extended the FP&A systems and achieved a 100% inventory rate for $1+ billion of fixed assets. SHIRE CAMPUS, Lexington, MA Provided full Financial Planning & Analysis services for a 650,000+ SF award winning research, development and manufacturing Biopharma campus. Completed 5 IRS audited cost segregations for $1+ billion that delivered hundreds of millions of immediate tax benefits. Business Intelligence and ERP Systems Implemented and generated significant business efficiencies in multiple SAP modules for Global Biopharma cGMP, cGXP, FDA and the like regulated operations. Implemented SAP Internal Order and Settlement structures for Clinical Trials, Manufacturing, Development, IT and Quality Control/Analysis which enabled user specific ‘real-time’ reports. Significantly reduced reliance on excel models and configured SAP to generate reports. Budgets, Forecast & Long Range Plans Manage multiple Budgets, Forecasts & Long Range Plans for Biopharma operations on a monthly, quarterly and annual basis and being process owner during the budget and planning cycles. Provide accurate judgement calls on how the Finance function will record the actual transactions under GAAP, IFRS, SEC and IRS regulations resulting in zero reclassifications from recommended budget categories. Interpret terms of complex legal documents and appropriately record the transactions for FP&A purposes. Accurately forecast complex revenue recognition transactions with zero reclassifications. Operations Manage monthly and on-going accounting and reporting processes for Biopharma operations for GAAP, IFRS and Tax Based portfolios. Evaluate accounting and financial transactions for compliance with accounting rules, tax regulations and reporting requirements. Establish accounting policies, internal controls and reporting guides for Biopharma FP&A operations. Manage year-end audit, Internal Audit, FDA and tax requests related to Biopharma FP&A operations.

Biopharma-FPA - Senior Consultant

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Page 1: Biopharma-FPA - Senior Consultant

Robert Half Management Resources Salaried Professional Services 1700 West Park Drive, Westborough, MA 01581 • 508-621-2300 • [email protected]

Seasoned international executive with over 20 years of public and private experience in

Finance Planning & Analysis with cGMP/cGXP experience in Research and

Development, Laboratories, Manufacturing and Bio Pharma IT. Verifiable success

creating and delivering outstanding FP&A and capital solutions using SAP, Oracle,

Hyperian and other packages for small divisions of $50 million up to $25 billion group

wide solutions. Talented in building commercial and financial solutions from the ground

up, implementing SAP, training teams and providing solutions to Executive Teams.

Proven abilities as a Finance Business Partner and adding value to operations. Excels as

a transaction manager and finance professional.

—————————— Key Examples of Success ——————————

Deep Bio Pharma experience in designing,

structuring and using FP&A systems and in

making effective use of SAP hierarchies, Internal

Orders, Settlements, Cost and Profit Centers,

Business Objects and Hyperion.

Extensive life cycle technology experience from

upgrading legacy Biopharma ERP systems to

SAP 4.0. Extensive lifecycle experience in

Biopharma SAP 6.0 rollouts, new General

Ledger and Biopharma Fixed Asset

implementations and upgrades. At Shire, he held

the highest authority level for capital approvals.

Approved, structured and analyzed transactions.

Built FP&A systems for all of the new $500+

million cGMP developments.

—————————— Areas of Strength ———————————

Finance Business Partner Annual Budgeting Product Lifecycle Forecasting

Capex Planning and Forecasts Long Range Planning Product/ Competitor Analysis

SAP Super User Cash Flow Budgeting GAAP/IFRS & IRS Assumptions

—————————— Skills and Experience ———————————

Areas of Specialization Research and Development

Clinical Trials

Laboratories

Large Scale Development Laboratories

Quality Control

Contract Manufacturing

Plant Manufacturing

Supply Chain

Technical Operations

Bio Pharma IT

Bio Pharma Tax and IRS Cost Segregations

MLSC Grants

Sunshine Act

Royalty Calculations, Billings and Audits

Medicaid and Medicare

IT Projects from Concept to Deployment

All Bio Pharma Capital Projects

cGMP SAP Super User and Trainer

Shopping Cart and Accrual Trainer

Industry Experience All Stages of Clinical Trials

Live Animal Research

Orphan Drugs

Cell Culture

Bio Reactors

Purification

Vaccines

Technology Expertise cGMP Qualified

GAAP, IFRS, IRS, SOX, SEC

SAP, SRM, Oracle, Hyperion

DOA, Cockpits and Accrual Manager

Blackline

Organizations/Operations Served Shire Plc

Alewife Cell Culture Plants

300 Shire Way Cell Culture

300 Shire Way QA and QC

200 Shire Way Laboratories

200 Shire Way LSDL

125 Spring St Research Operations

125 Spring Street Live Animal Division

400 Shire Way Cell Culture

400 Shire Way Manufacturing

700 Main Street Labs

700 Main Street LSDL

Global IT Operations

SAP Implementation Division

SAP Upgrade Division

North Reading Supply Chain Operations

Kmart

Target

Coles and Bi-Lo Supermarkets

Myer Department Stores

Officeworks

World 4 Kids

Liquorland

The Davis Companies

Reit Management and Research LLC

Arthur Andersen Transaction Services

Education and Certifications CPA license – Australia

Chartered Secretary and Administrator –

London, UK

Michael Irving, CPA Bio Pharma and FP&A- Management Consultant

“Roll up the sleeves work ethic that builds loyalties with teams, executive boards and investors”

SELECTED PROJECTS

BIO PHARMA FP&A SYSTEMS, design,

development, rectification, rollout and

training. During the first 12 months he received recognition from the Group Audit

Committee for implementing new FP&A

systems and processes for the Lexington Campus. Later he extended the FP&A

systems and achieved a 100% inventory

rate for $1+ billion of fixed assets.

SHIRE CAMPUS, Lexington, MA

Provided full Financial Planning &

Analysis services for a 650,000+ SF award winning research, development and

manufacturing Biopharma campus.

Completed 5 IRS audited cost segregations

for $1+ billion that delivered hundreds of

millions of immediate tax benefits.

Business Intelligence and ERP Systems

Implemented and generated significant business efficiencies in multiple SAP modules for Global Biopharma cGMP, cGXP, FDA and the like regulated operations.

Implemented SAP Internal Order and Settlement structures for Clinical Trials, Manufacturing, Development, IT and Quality Control/Analysis which enabled user specific ‘real-time’ reports.

Significantly reduced reliance on excel models and configured SAP to generate reports.

Budgets, Forecast & Long Range Plans Manage multiple Budgets, Forecasts & Long Range Plans for Biopharma operations on a monthly,

quarterly and annual basis and being process owner during the budget and planning cycles.

Provide accurate judgement calls on how the Finance function will record the actual transactions under GAAP, IFRS, SEC and IRS regulations resulting in zero reclassifications from recommended

budget categories.

Interpret terms of complex legal documents and appropriately record the transactions for FP&A purposes.

Accurately forecast complex revenue recognition transactions with zero reclassifications.

Operations

Manage monthly and on-going accounting and reporting processes for Biopharma operations for GAAP, IFRS and Tax Based portfolios.

Evaluate accounting and financial transactions for compliance with accounting rules, tax regulations and reporting requirements.

Establish accounting policies, internal controls and reporting guides for Biopharma FP&A operations.

Manage year-end audit, Internal Audit, FDA and tax requests related to Biopharma FP&A operations.