SUMMARY

• Recognized throughout career for being a strong, quality focused, and results driven Industry leader leveraging 10 years of experience in the Pharmaceutical Manufacturing Industry. Successful in developing award winning strategies dat has enabled global growth resulting in an over 40% increase in sales over forecast.
• Developed and implemented process improvement initiatives dat resulted in a 54% reduction in line changeover. An experienced leader with a strong voice, a subject matter expert in aseptic manufacturing, quality, and compliance, and an effective team builder.

COMPETENCIES

• Aseptic Filling and Operations
• QC background
• Cross Functional Leadership
• Credible Leadership
• Area Management
• Project leader
• Lean Manufacturing / 5S
• cGMP & KPI’s
• FDA 21 & CFR 210&211
• Continuous Improvement
• Problem Solving and Innovation
• Liquid Filling and Lyophilization
• Sterilization
• RABS
• Aseptic Technique
• Training & Development
• Team Building
• Executive Presentations
• Strategy Development
• Effective Communication
• Performance assessment
• Production Planning/Scheduling

WORK EXPERIENCE

Confidential - St. Louis, MO

Operations Manager

Responsibilities:

• Self-directed and proactive use of technical applications on large scope applications/projects.
• Represented Operations in a major project for an Aseptic Processing addition to the facility.
• Contribute to achievement of team, plant and/or global goals by ensuring dat projects are completed on schedule and within budget.
• Monitored and managed the efforts of subordinate colleagues to achieve delivery of short-term and mid-term goals.
• Interview/Hire/terminate employees
• Lead and motivate others, generating commitment and a shared sense of purpose. Empower others to contribute their best.
• Identifies/executes significant process improvements using ingenuity, innovation, and creativity while ensuring solutions are consistent with organizational objectives.
• Gathered, analysed, and interpret, relate and compare information to identify cause and effect relationships
• Managed large volume, high speed Aseptic Filling, inspection, and formulation of antidotes, nerve agents, and anaphylaxis drugs for military and civilian use.
• Completed a specialized Aseptic Technique training program in order to expertly perform Aseptic Operations and preserve product quality.
• Lead production meetings with Executive Board members and analysed production metrics to evaluate productivity.
• Assisted in equipment validation activities and participated in smoke studies and media fills to qualify filling lines.
• Revised production schedules by coordinating production activities cross-functionally.

Confidential - Alsip, IL

Production Supervisor

Responsibilities:

• Achieved an award winning Kaizen activity which tripled output, reduced downtime by 70%, and eliminated overtime.
• Developed new processes dat lead to a 54% reduction in line changeover rate.
• Provided high-caliber leadership and expertly lead the establishment of an ISO 7 clean room for the transplant of a Pharmaceutical Drug from Japan to the United States.
• Created, Validated, and executed an ISO 7 Cleaning Program.
• Directed High Level Management Meetings including C Level Executives.
• Created and Lead a facility wide training program on cGMP and CFR 210&211.
• Created performance goals for direct reports
• Addressed performance issues while developing, mentoring, and coaching associates into strong teams.
• Implemented a visual display system of KPI metrics to enhance communication of information to associates and to make highly requested information available to executive committee members and visitors.

Confidential - Melrose Park, IL

Production Supervisor

Responsibilities:

• Managed and participated in the Aseptic Filling of vials, component preparation, lyophilization and Inspection of Pharmaceutical drugs for injection.
• Direct report to 68 hourly associates, including an Aseptic Team Lead, Aseptic Filling Operators, Lyophilization operators, Capping Machine Operators and vial inspectors.
• Closely monitored six Aseptic Filling/capping/Inspection lines including RABS, running simultaneously, as well as four Lyophilizers
• Completed a specialized Aseptic Technique training program in order to expertly perform Aseptic Operations and preserve product quality.
• Lead production meetings with Executive Board members and analysed production metrics to evaluate productivity.
• Assisted in equipment validation activities and participated in smoke studies and media fills to qualify filling lines.
• Resolved production issues through strategic planning.
• Revised production schedules by coordinating production activities with other departments.

Confidential - Portage, IN

Production Supervisor

Responsibilities:

• Simultaneous compounding, processing, and packaging lines with 30 operators.
• Demonstrated strong, credible leadership by identifying and resolving production issues in a sound and decisive manner.
• Organized production data into charts for reporting shift summaries to the Executive Committee.
• Key member in the recruitment and employee appraisal process.
• Created and Lead a facility wide training program on cGMP and CFR 210&211.
• OQ/OQ/PQ Validation testing.

Confidential, Bradley, IL

Production Supervisor

Responsibilities:

• Managed and participated in the Aseptic Filling of Flu Vaccines into syringes and Clinical nutrition products into vials, component preparation, Heat pasteurization, lyophilization and Inspection of Pharmaceutical drugs for injection.
• Direct report to over 30 Union operators monitored 3 Aseptic Filling lines, including RABS and promoted to Production supervisor role after starting in the QC Microbiology Department.
• Analysed production metrics to evaluate productivity and created a visual representation of data for reporting
• Assisted in equipment validation activities and participated in smoke studies and media fills to qualify filling lines.
• Resolved production issues through strategic planning.
• Revised production schedules by coordinating production activities with other departments.
• Performed Environmental Monitoring of Aseptic Filling areas and ISO 7 clean rooms such as RODAC plates, Air Particulate sampling, water loop sampling, and SMA compressed air/gas sampling
• Sterility testing of final products
• Performed Bacteriological Water analysis through Sterile Membrane Filtration
• Bioburden testing of In-Process materials
• Identification of Microorganisms