Eugene Rusch

*** ****** ****** *****

Chelsea, Alabama 35043 Cell: 937-***-****

acb1a1@r.postjobfree.com

Summary

Business/Technical Operations Executive

Operations executive experienced in building and managing successful global

businesses through: Strategic Planning, Operational Management, Supply

Chain Management, Financial/Budget P&L Analysis and Change Management.

Business start-up experience and thought-leader who understands the

Pharmaceutical Business and how to integrate human capital management to

achieve financial results by setting the Vision, influencing and driving

change, building competency, quality and growing employee engagement.

Demonstrated ability to manage large complex operations. Successfully

directed several major plant expansions. Lead business and technical teams

as part of due diligence for a variety of possible business acquisitions

and partnerships. Exceptional track record with FDA, EMEU and other

regulatory agencies.

Superior communication skills, vision and concept development, general

management, GMP compliance, organizational development skills, profit

maximization and cost containment, project management, supply chain

management, strategic planning and implementation.

Career Experience and Accomplishments

February 2011- Present Executive Leadership LLC

Chelsea, AL

President (Corporate Founder)

Executive Leadership LLC is a private consulting firm focused on providing

business strategy development, process improvements and executive coaching

to the Pharmaceutical/Biopharmaceutical Industry.

May to August 2013 working as a senior consultant with Quintiles,

participated in a process improvement/reliability engineering project at an

aseptic manufacturing CMO providing the following:

. Process and facility improvements

. Shop floor technical leadership

. Development of on time start tracking tool for manufacturing

. OEE program implementation planning

. Root Cause Analysis process for deviation investigations

. Pre CIP/SIP cycle readiness checklist

. Reliability process implementation and documentation for "right first

time"

April to September 2012 working as a senior consultant with Quintiles,

participated in regulatory remediation activities at a major pharmaceutical

company providing the following.

. Process and facility improvements

. Shop floor QA activities

. Development and implementation of QA check lists for shop floor real

time monitoring

. Batch Record and investigation report reviews and approvals

. SOP reviews and improvements

. Increased shop floor employee and management cGMP awareness

. Management training and mentoring

. Certification of QA personnel

. Personnel/Material flows and appropriate gowning procedures to meet

cGMP and international regulations

March 2010 - February 2011 SurModics, Inc.

Birmingham, AL

Vice President of Manufacturing (Corporate Officer)

SurModics, Inc. is an integrated Coatings, Diagnostic and Pharmaceutical

company. SurModics Pharmaceuticals is the drug delivery division with the

strategic plan of becoming a clinical and commercial manufacturing company

by 2015. Hired to assist in the strategic planning and

implementation/creation of the overall manufacturing organization. As the

head of a highly matrixed organization lead the manufacturing operations

for the Eden Prairie coatings/diagnostics and Birmingham pharmaceutical

operations. Led the creation of a manufacturing, facilities and supply

chain infrastructure to manage resources across two sites prior to the

decision to divest the Pharmaceutical operations.

. Led the start up and completion the Lakeshore Parkway manufacturing

facility that included support laboratories for testing and release of

product and facility monitoring along with pilot plant operations for

early development

. Created the organizational structure to support technical operations

that included EHS, manufacturing and supply chain functions

. Created the infrastructure and organization to manage a >200% increase

in production volumes over 5 years

. As a company officer engaged with Executive Committee and Board of

Directors to create a strategic plan for the entire corporation

. Initiated risk management and business continuity programs for the

Birmingham manufacturing operations for the purpose of a major repair and

loss of manufacturing capabilities of the facility.

March 2004 - November 2009 Alkermes, Inc.

Wilmington, Ohio

Vice President/General Manager-Manufacturing Operations

Hired by Alkermes to drive the change from a research and development based

culture to a GMP compliant commercial manufacturing operation while

containing costs and increasing profit. Alkermes, Inc had increasing

annual manufacturing revenues of $40MM - $117MM in Fiscal Years 2005-2009.

Anticipated revenues for FY 2010 will be approximately $121MM. The company

has over 550 employees at two sites, Cambridge, Massachusetts and

Wilmington Ohio. As VP and General Manager of Manufacturing I managed 4

direct report Directors/Senior Managers and over 310 manufacturing,

quality, engineering/maintenance, development and various support personnel

supporting two commercial products, process development and clinical

manufacturing. The current portfolio of products is based on the

proprietary Medisorb Delivery Technology resulting in an extended release

Injectable product manufactured at the Wilmington Ohio plant.

. Responsible for plant operations, facilities engineering, maintenance,

safety, security, and technical support at Wilmington Ohio manufacturing

site. Technical advisor/liaison to partner (Amylin) site in West Chester,

Ohio.

. Consistently delivered increasing returns across the product portfolio

for the past 5 years.

. Managed annual expense budget of $100 million and capital budget in

excess averaging $20 million per year.

. Managed the continuous expansion of plant and office facilities to meet

strategic corporate goals and sales forecast. Over 100,000 sq. ft of new

construction and renovated space was completed on time and within budget.

. Collaborated on design and completed an 25,000 sq. ft. general office

expansion.

. Completed the construction of a 60,000 sq. ft. warehouse facility.

. Oversight of the construction of over 6,000 sq. ft. of new research and

development offices and laboratories.

. Directed an internal renovation of over 3,000 sq. ft. to replace outdated

areas of the existing facility.

. Created the infrastructure and organization to manage a >200% increase in

production volumes over 5 years. Plant output rose from just under 3

million doses to over 8 million doses in a 5 year period. Staff was

increased from approximately 100 direct labor, management and technical

support staff employees to over 300 direct labor, management and technical

support staff employees.

. Site named the External Manufacturer of the Year in 2007 by the Global

Pharmaceutical Supply Group of Janssen

. Oversight of Six Sigma and Lean Manufacturing programs for process

improvement and training

. Well established Safety and Quality Culture throughout the organization

. Created a manufacturing technical support function by initially devoting

a small staff focused upon process improvement, failure investigations,

validations and new product start-up/launch. The technical support group

was expanded over a period of approximately five years to also include

operational support of manufacturing automation/systems, Oracle

application support, operator skills training, and manufacturing

documentation.

. Increased operating efficiencies year after year by improved

manufacturing methods using Six Sigma tools, enhanced process technical

understanding and support, and enhanced operator training. Manufacturing

efficiency increased over 100% in five years. Manufacturing efficiencies

offset the impact of more complex processes and dosage forms as well as

the impact of smaller batch sizes.

. Leveraged plant capacity and a three shift, twenty-four hour seven day

operation to maximize capacity utilization and absorption of overtime.

. Received no 483 major observations in last 5 years. Three separate

biennial inspections by teams of FDA investigators, and performed as

systems based inspections, resulted in no observations. The latest

inspection was conducted in August 2008 and included the newly qualified

plant expansion.

. Responsible for the validation and manufacturing of launch quantities of

the company's first proprietary product in 2007.

. Initiated a risk management and business continuity programs for the

Wilmington manufacturing operations for the purpose of a major repair and

loss of manufacturing capabilities of the facility.

August 1980 - March 2004 Hoffmann-LaRoche Pharmaceutical

Nutley, NJ

Director of Parenteral Manufacturing Operations

. Responsible for plant operations in Nutley, NJ. Overall operations

consisted of approximately 45 total employees. Manufacturing encompassed,

sterile liquids and packaging operations for global distribution. A

significant portion of the operations was devoted to the launch of a new

AIDs product and dosage form production of Oncology products.

. Created departmental restructuring plan so that everyone was working

towards the same shared goal/endpoint and understood their current and

future roles and responsibilities

. Maintained critical cross functional working groups and relationships

with Quality, Engineering and Maintenance, Validation and Supply Chain

during launch planning

. Created a leadership team within the Parenteral manufacturing department

to establish priorities and deal with issues as they arose in a timely

manner

. Developed detailed plans for re-configuration of manufacturing operations

resulting in the downsizing of the Nutley Parenteral manufacturing

operations leading to its closing in 2006.

. Successfully sustained manufacturing operations through FDA, Canadian and

EU regulatory inspections without a major observations or interruption of

product supply

Director Antibiotic Manufacturing Operations

. Directed pharmaceutical manufacturing operations totaling 75,000 sq. ft.

and employing 85 people.

. Produced over 25 million units for distribution in the US supporting over

$600 Million in revenue

. Successfully salvaged an FDA inspection in progress that had taken a

negative tone and turned it into a favorable outcome

Various positions of increasing responsibility at Hoffmann-LaRoche

Director of Compliance and Technical Training

. Participated in the upgrade and creation of the quality systems required

by US and EXUS regulatory agencies.

. Responsible for batch card simplification and training

. Responsible for operator training programs for job function, FDA good

manufacturing practices and technical programs

Manager of Pharmaceutical Engineering and Maintenance

. Participated in the upgrade of the facilities to meet compliance for

global distribution of product from the Nutley site

. Created a maintenance management system in SAP

Business Process Leader

. Participated in the integration of Syntex products, facilities and

personnel following the acquisition by Hoffmann-LaRoche

. Participated on a cross functional team to improve product delivery and

obtain world class delivery as measured by order fulfillment and line fill

rate at the customer.

Facility 2001 Project Team Member

. Participated on a cross functional technical team to investigate new and

existing technologies for application in Pharmaceutical manufacturing

. Developed a design package for a modular facility and associated

utilities

Manager of Engineering

. Responsible for HVAC, High Pure Water and Production electronics and

instrumentation maintenance and operations

Senior Supervisor Sterile Manufacturing

. Participated in the design, construction, qualification and validation of

a multi floor 60000 square foot aseptic manufacturing facility

. Direct supervision of aseptic formulation, filling and inspections of

vials, syringes and ampoules manufactured in Nutley

August 1979 - August 1980 Warner Lambert Corp.

Morris Plains, NJ Supervisor

of Second Shift Operations

August 1976 - August 1979 Schering-Plough Corp.

Union, NJ

Manufacturing Chemist Sterile Operations

Education

BS Microbiology - Rutgers University 1976

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