ALEXANDER BALAZ

CELL: 732-***-****

acgdy4@r.postjobfree.com

Pharmaceutical/Biotech Operations Professional A strong leader who established quality-driven performance standards for

management systems, manufacturing processes, engineering process design, and production equipment, utilities, facilities, packaging &

labeling.

Qualifications

• A decision-maker with highly-developed organizational, communication; interpersonal skills

• Project Management; Vendor Qualification, selection and monitoring

Training and Mentoring in GMPs, FDA Guidelines and Industry Standards

Development of Infrastructures, Document Control Systems, and Cost & Schedule Tracking Matrixes

Cross-functional team and multi-site management

International experience

FDA liaison

Expertise

• Analytical problem solver

Process design & development

Developed product life cycle management system

Product launches

Technology transfers

CAPA, Change Controls, Batch Record Dispositions

Deviations, Investigations and Resolutions

Promotes continuous process improvement philosophy

Implementation & verification for compliance

Statistical methodologies

Validation qualifications: processes, equipment, utilities, facilities, cleaning

Commissioning

Documentation control systems

Product scale-up

Pharmaceutical & Biotech Product Experience

Biotechnology Products

Large & small parenterals

Blood Fractionation Products

Sterile Injectable Products

Solid Dose Direct Compression and or Granulated Products

Vaccine (cell-culture manufacturing, fermentation, centrifugation, clarification, concentration, ultra-filtration, pooling &

sterile filtration) and egg based processes

Sterile Liquid & Solid Dose, Sterile Powders, Aerosols and Ointments

Lyophilization, Biologics and Metrology

Professional Experience

Alann and Associates July 2007-Present

Director of Projects – Updated Quality Systems; set aggressive timelines and led teams for restarting manufacturing after

implementation of the current process validation FDA Guideline requirements; up-dated the process design & implementation for

product scale-up, developed product life cycle management system, continuous process verification, up-dated product disposition

documentation, mentored the use of statistical methodology, developed training materials & procedures, up-dated manufacturing

operations for solid dose, aseptic and biotechnology products; up-dated the facilities, utilities and process equipment qualifications

for McNeil, Sandoz (Novartis), Hill Dermaceuticals and Heamacure Pharmaceuticals.

Sanofi Pasteur 2006-July 2007

Deputy Director of Validation - Managed, led, organized and scheduled the multiple vaccine process validations for the new Flu

Vaccine Facility. Led a team of Sanofi Personnel from Manufacturing, Engineering, Quality Assurance, Quality Control, as well as

numerous consultants in a joint venture with Merck to develop new products.

Alann and Associates 1999-2006

Director of Quality Projects- Managed projects for product scale up for solid dose, aseptic and biotechnology products, as well as

process engineering, commissioning, manufacturing operations, engineering, and validations for Watson Pharmaceuticals, Eli Lilly,

Pfizer, Teva, Vital Pharma, Vital Signs, and TG United Labs.

Vital Pharma, Inc.1996-1999

Regional Manager, TVG West Coast - Managed the solid dose, biotechnology, pharmaceutical and medical device process

development, process engineering, commissioning and qualification projects for the West Coast at Baxter, Bayer, Genentech,

Allergan, La Jolla Pharmaceuticals and Advanced Technology Pharmaceuticals.

Life Sciences International 1990-1996

Manager of Projects, Process Design, Commissioning and Validation –Directed the technical aspects of commissioning and

validation projects by managing the work performed by seventy (70) Project Managers and Lead Validation Specialists and the

development and execution of the Validation and Commissioning for Wyeth, Praxis Biologics, Bayer Pharmaceuticals, Bio Pure,

Schering Plough, Allergan, Berlex, Ranchler Pharmaceuticals, Able Laboratories, Barre National, IPR Astra/Zeneca, Zeneca,

IVAX, Liposome, Merck, and Baxter.

Bausch & Lomb Company 1983-1990

Manager Process Engineering - Directed the process engineering development; the commissioning and validation of process

equipment, utilities; and processes for the manufacture of sterile ophthalmic solutions, prescription sterile ointments, as well as,

medical device accessories.

Bristol Meyers Squibb 1975-1983

Director of Manufacturing and Engineering Directed the (80) managers and engineers in the engineering department and

manufacturing operations. Projects included design, installation and manufacturing of several sterile injectable and oncology

products, oral solid dosage and liquid products and medical devices. Project activities included directing the process design

development, project engineering, packaging engineering, metrology, manufacturing as well as validation, commissioning, and

document control systems. Also, directed the commissioning, and validation of anti-cancer manufacturing process equipment,

laboratory facilities and utilities in Puerto Rico (Lyophilization processes) in Mayagues, Puerto Rico; the sterile filling and packaging

facility in Barcellonetta, Puerto Rico.

Education:

• Masters Degree in Management Science - Stevens Institute of Technology Hoboken, NJ

• Bachelor of Science in Chemical Engineering – University of Belgrade Yugoslavia

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