John V. Horab

*** ****** ***** **** ****: 716-***-****

West Seneca, New York 14224 E-mail: abgsmh@r.postjobfree.com

Professional Summary

Accomplished Manufacturing Manager with twenty-six years of progressive

leadership experience in manufacturing and quality systems within the

pharmaceutical industry that has achieved operational excellence in the

areas of Quality, Productivity, Safety, Delivery, Environment and Cost

Functional Expertise:

Aseptic Pharmaceutical Drug Manufacturing, Training Development, Project

Management, Lean Manufacturing, Facility Start-up and Commissioning, and

Strategic Planning

Manufacturing Expertise:

. Organizational Leadership . Continuous Process Improvement

. Regulatory Compliance

. Procedure Development . New Product Development .

Employee Development

. Quality System Development . Formulation, Filling and

Packaging . Teambuilding

. Batch Record Development . Aseptic Processing . Lean

Manufacturing

Professional Experience

Fresenius Kabi Inc. (APP), Grand Island, New York 2009 - Present

Production Manager, Manufacturing (2009 - Current)

Manages an operational staff of 5 indirect and 80-100 direct labor

personnel in aseptic processing, formulation, filling, terminal

sterilization, and packaging of injectable pharmaceutical drug products.

Oversees the scheduling, incoming quality control, production operations,

quality assurance, engineering, maintenance, equipment validation,

training, investigation of non-conformities, laboratory testing contacts,

and product release for the assigned cell

. Site project leader for developing the manufacturing process for 6 new

sterile penicillin product codes scheduled for EU launch

. Facilitated and developed the manufacturing process for 16 new sterile

penicillin product codes scheduled for US launch

. Manufacturing team leader for the installation and procedural

development of Restrictive Access Barriers on aseptic filling lines

. Established preliminary line layout for new aseptic processing area

that eliminated cross-contamination, increased productivity and

efficiency by 25%, and added automated cleaning processes

. Created core training curriculum for aseptic processing and terminal

sterilization manufacturing cells which included procedural and on-the-

job training proficiency competencies

Astellas Pharma Manufacturing Inc. (Fujisawa), Grand Island, New York

1999 - 2009

Manager, Manufacturing (1999 - 2009)

Managed an operational staff of 2 indirect and 25 direct labor personnel

in the formulation, filling and packaging of topical pharmaceutical drug

products

. Established site-wide training program for Lean Manufacturing

philosophy of 5S

. Implemented Washout Reduction/Continuous Batching plan that increased

capacity and reduced water usage by 25%. Eliminated the need for a

planned manufacturing expansion, saving over $25 million in

construction expenses

. Successfully launched US and EU commercial manufacturing of topical

pharmaceutical drug products, with sales exceeding $100 million within

3 years of launch

. Managed process and procedural development for Cream and Gel

formulations as an alternate vehicle for delivery of a pharmaceutical

active ingredient; resulted in submission to Phase III clinical trials

John V. Horab Page 2

Professional Experience (continued)

. Maintained strict adherence to organizational standard operations

procedures and policies, resulting in 8 FDA inspections with zero 483

observations for non-compliance of cGMPs

. Participated on the Corrective Action/Preventative Actions (CAPA) Team

to investigate negative quality trends and implement corrective

measures

fujisawa healthcare inc, Grand Island, New York 1994 - 1999

Supervisor, Manufacturing (1994 - 1999)

. Managed new facility construction and commissioning from manufacturing

operational perspective

. Identified and purchased all manufacturing support items to meet start-

up requirements for clinical and stability ointment batch production.

Conducted facility and site acceptance testing protocols

. Managed $90K project that set-up and established functional receiving

and shipping warehouses

. Reduced material scrap by 50% by reassigning remaining components to

future batches

. Facilitated continuous improvement of the manufacturing process and

training of personnel which led to a 50% reduction in deviation reports

fujisawa USA inc., Grand Island, New York 1989 - 1994

Supervisor, Physical Process Control (1989 - 1994)

. Developed site comprehensive training program on Three Zone Statistical

Process Control

. Conducted supplier audits for raw materials, primary containers and

closures, and labeling material

. Co-developed site strategy plan for the reduction of fill volumes

utilizing trended statistical data and vial/syringe hold-up studies

. Created and instituted Performance Qualifications for vial washing,

filling, packaging, and inspection equipment

. Developed and implemented site auditing procedures and training program

for self-inspection

lyphomed inc., Grand Island, New York 1988 - 1989

Technician, Audit / Validation (1988 - 1989)

. Developed standard operating procedures for the assurance of quality

for the cephalosporin and liquid fill manufacturing processes

. Converted liquid fill lines to statistical process control, creating

stable manufacturing process to allow for the trending of process

related data

. Audited manufacturing processing areas and developed long term

corrective action plans with site supervision

Education

Saint Bonaventure University, St. Bonaventure, New York 14778

MBA - Management/Finance (2008)

Niagara University, Niagara University, New York 14109

BS - Biology (1987)

Training/Development

. Situational Leadership . Lean Manufacturing . 5s

. Coaching Skills . Valuing Working Styles . Microsoft

Office Suite

. Documentum . Total Quality Management . Kaizen

. Trackwise . eTime and DayForce . Root Cause Analysis

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