Major Accomplishments

JASON J. ORLOFF PharmStat 2000 Dempster Plaza, Evanston, IL 60202 (847) 424-1314 | [email protected]

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, 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.  Invited to train FDA in Design of Experiments at the Center for Biologics Evaluation & Research.

Regulatory  Contributing author on the PDA’s Technical Report 59 on “Utilization of Statistical Methods for Production and Business Processes”.  Contributing author on the ISPE’s Baseline Guide for Q10 chapter “Process Performance and Product Quality Monitoring”.  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. JASON J. ORLOFF (847) 424-1314 | [email protected]

 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).  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: Design-Expert, 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 PharmStat 2010 – Present VP and Principal Statistical & Engineering Consultant

Stat-Ease 2010 – Present Design of Experiments Contract Trainer

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 JASON J. ORLOFF (847) 424-1314 | [email protected] 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.