Orloff Jason JR esume

							                                         JASON J. ORLOFF
                                     c
                                    /o Torbeck & Associates, INC.
                               2000 Dempster Plaza, Evanston, IL 60202
                                 (312) 515-7195 | info@jorloff.com

Mr. Orloff brings ten years of experience in managing projects as well as manufacturing, quality, and
regulatory issues in the pharmaceutical industry. A Chemical Engineer with real-life expertise at applying
statistics in a highly regulated environment, Mr. Orloff is able to work effectively across all levels of an
organization as well as make high level concepts accessible to a variety of audiences. Strengths include:
Strategic Thinking, Business Systems Design appropriate to Business Need, Technical Expertise, and
Transformational Leadership.

Major Accomplishments
Statistical Applications
     Championed the use of Lyo validation data to improve sampling, saving almost $1MM / year.
     Investigated Process Failure and Implemented Engineering Controls to eliminate risks to biotech
         fermentations totaling approximately $14MM / year. Awarded Abbott Engineering Excellence.
     Detailed the statistical basis for using on-unit encryption to gather business intelligence, showing
         dollar impact to bottom line of counterfeits and diverted products through the supply chain.
     Identified the process control point leading to fermentation failures and spearheaded resulting
         process improvement efforts that doubled yields, exceeding filed recovery limits. Received Abbott
         Engineering Excellence Award.
     Defended Aventis' Lyophilization Validation philosophy from 483 observations by extracting &
         statistically analyzing product quality data.

Regulatory
    Assisted in presenting on-dosage brand protection to the FDA at White Oak, Silver Spring, MD.
    Representative to State and Federal Agencies for Controlled Substance Licensing.
    Coauthored the Drug Master Filing for NanoInk’s Brand Protection Technology, performed
        annual reviews, and submitted supplements and amendments.
    Coordinated GMP, GLP, and Security Audits; prepared gap analyses to identify deficiencies; built
        consensus on remediation strategies and implemented them.
    Cross-functional team member bringing three new formulations online; provided subject matter
        expertise during FDA’s Pre-Approval Inspection (PAI) and audits by the Paul Ehrlich Institute.
    Wrote the FDA Design Review Summary of a $50 million facility beginning manufacture of
        pharmaceutical intermediates under cGMP for the first time.
    ISO/TC 198 WG 9 contributor to “Aseptic processing of health care product – Part 3: Freeze-
        drying” for consideration on ISO/CD 13408-3.

Project Management
     Provided project management to Directors and the VP of Engineering for the manufacture of
        Prototype through Production Machines as well as project manager and technical representative to
        customers.
     Managed the technology transfer of a Phase II clinical product from development to production
        addressing mechanical, procedural, compliance, and quality issues.

Business Systems Design
     Implemented a Quality system in manufacturing starting from nothing with special attention to
        regulatory requirements of a small, diagnostics and device supplier to the pharmaceutical industry.
     Identified and corrected shortcomings in a facility that had been operated for 14 years without
        Good Manufacturing Practices. Systems implemented include Corrective and Preventative
        Actions, Preventative Maintenance, Equipment Commissioning and Qualification, etc.
     Implemented Total Quality Management in Microsoft Dynamics AX (ERP) for such fundamental
        business systems as inventory & consignment of R&D materials; shipping & receiving of Special
        Security Substances, Instrument Calibration; Document Control, and Statistical Process Control.
     Managed team for routine 5-year OSHA plant audits “Failure Mode Effects Analysis” (FMEA).
                                     JASON J. ORLOFF
                                (312) 515-7195 | info@jorloff.com
       Reviewed management of change documents and incident investigations to clarify operating
        history and streamlined Process Hazard Analysis (PHA), decreasing total meeting time by 30%.

Core Competencies and Professional Training
       Statistics Software: Minitab, JMP, R, Excel, and SAS
       Project Management including MSProject, Team Building, and Negotiation.
       Enterprise Resource Planning: Microsoft Dynamics AX, TQCM, TECM
       Multiple Classes in Manufacturing SPC, Validation Statistics, and Design of Experiment.
       21 CFR, Part 210 & 211, International Society of Pharmaceutical Engineers “GMP 201”.
       21 CFR Part 820 & Premarket Notification 510(k), CDRH Learn, Quality System Regulation.
       OJT: 21 CFR Part 58, ISO 9000, and OSHA Process Safety Management 29 CFR Part 1910.
       Aseptic Gowning & Technique, Equipment Sterilization and Cleaning.
       Technical Japanese (Intermediate), The Imperial University of Hokkaido, Japan.
       Certified Quality Engineer (CQE) applicant.
       Spanish (Foundational), San Juan, Puerto Rico. German (Foundational), Kenyon College, OH.

Professional Experience
J. Orloff & Associates, INC. 2010 – Present
Statistical & Engineering Consultant

NanoInk, Skokie, Illinois 2006-2009
Associate Quality Manager

Abbott, North Chicago, Illinois 2003-2006
API Lead Bio-Process Engineer

Aventis, Kankakee, Illinois 2001-2003
Lyo-Validation Team Lead

Synthetech, Albany, Oregon 2001
Validation Engineering Consultant

ATOFINA, Portland, Oregon 2000 - 2001
Process Safety Management

U. W. Biochem Dep't. & Pilot Plant, Madison, Wisconsin 1999 - 2000
Bio-molecular Chemistry Process Engineer & Teaching Assistant

Searle-Pharmacia, Skokie, Illinois Summer of 1999
Process Engineering Intern

Education
Masters of Science, Quality Assurance & Regulatory Sciences, Northwestern University, Chicago, IL

Masters of Science, Applied Mathematics & Statistics, DePaul University, Chicago, IL

Bachelor of Science, Chemical Engineering, University of Wisconsin, Madison, Wisconsin

Additional Information
    1998-1999 Yearlong study at Hokkudai, an Imperial University of Japan, on Full Scholarship.