Vita of Jason Orloff

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.
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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 and global sampling plan 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.
• 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 & Security 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

Achievements, Awards, & Honors

1995 Inducted into Tau Beta Pi, Engineering Honor Society <Click here for scan.>

1997-1998 Full Scholarship at Hokkudai, an Imperial University of Japan, for Japanese and Applied Chemistry.

 

1998-1999 Hoofer-of-the-Year for Mediation of a Financial Crisis and Executive Service.

 

2001 Membership in International Society of Pharmaceutical Engineers (ISPE).

 

2003 Membership in Parenteral Drug Association (PDA).

 

2004 Abbott Engineering Award <Click here for scan.>

 

2004 Abbott Engineering Excellence <Click here for scan.>

 

2005 Inducted into Sigma Xi, Scientific Research Society <Click here for scan.>

 

2008 Membership in ASIS International.

 

2010 Awarded scholarship to Joint Research Conference on Statistics in Quality, Industry, & Technology at NIST.

 

2010 Contributor at Integrated Implementation Workshops for ICH.Q8, Q9, and Q10, Washington D.C.

 

2010 Serving on ISPE committee to write industry guidance on Q10: Process Performance and Product Quality Monitoring.