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The international ISPE organization is seeking subject matter expert (SME) volunteers to provide assistance in two areas: writing questions for the Certified Pharmaceutical Industry Professional^TM (CPIP) examination and updating the content of several online courses designed to provide fundamental global industry knowledge. These volunteer positions are described in detail below.

Subject Matter Expert - CPIP Exam Item Writer

Job Overview:

Become qualified to serve as a subject matter expert and write examination questions (items) for the Certified Pharmaceutical Industry Professional (CPIP) examination.

Qualification:

• Send a detailed resume identifying your job positions, primary duties and assignments, and years of industry experience to the ISPE Professional Certification Department.
• The ISPE Professional Certification Commission (PCC) Examination Development Committee reviews your resume and determines where your expertise matches the technical knowledge areas to be covered on the exam.
• Attend an on-line item writing webinar.
• Receive your item writing assignment and password.

Item writing:

1. Log-on to the ISPE-PCC item writing Website

2. Fill-in the item writing template for each item assigned

Purpose and Objectives:

Your expertise as a subject matter expert will greatly assist the CPIP^TM certification program in providing exam questions with industry segment and geographical diversity. As a qualified SME your capability and service as an item writer will receive industry recognition.

Complete by Date: ASAP

Response Method: Email your response to Jerry Roth jroth@ispe.org    

ISPE Staff Contact: Jerry Roth, PE, ISPE Director of Professional Certification

Subject Matter Expert - To Provide Content Updates for Online Training Courses

Job Overview:

Among the wide range of educational products ISPE offers, is a series of online courses to provide fundamental global industry knowledge. We are seeking subject matter experts to help us update the content of the following courses.

1. Facilities and equipment - Controls and automation

2. Product Development - Production scale-up and optimization

3. Production Systems - Production unit operations - drug (small molecule) and biologics

4. Supply Chain Management - Warehouse and distribution

Responsibilities of this Position:

Contribute job-related industry experience for updating content. Administrative and design support provided by ISPE staff.

Skills/Experience Requirements for this Position:

1. Facilities and Equipment: Knowledge of building management systems and types of process automation and associated controls

2. Product Development and Product scale-up and optimization: Knowledge of the options to increase and/or optimize production, critical factors of scale-up and their impact on manufacturability, impact of factors that can positively or negatively affect scale-up, and modeling techniques for optimization of product cycle time.

3. Production Systems - Production unit operations - drug (small molecule) and biologics: Knowledge of manufacture of active pharmaceutical ingredients, components, and excipients, unit operations, labeling and packaging operations, critical process equipment and utility systems' attributes (performance, functionality, construction, instrumentation) and their impact on personnel and product, controls required for receipt, storage, and dispensing of raw materials, and packaging materials, and industrial engineering standards, facility and equipment utilization, and operational efficiencies.

4. Supply Chain Management - Warehouse and distribution management: Knowledge of warehouse and distribution management systems, transportation and logistics systems, environmental storage and transportation controls for hazardous and non-hazardous materials, and distribution chain security and product disposition controls.

Length of Service:     2 to 3 days for each course

If you are interested in volunteering for this position please click the link to complete a