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Pharma Technical Services: Structuring for Manufacturing Process Ownership

ID: OP-84


45 Info Graphics

28 Data Graphics

132 Metrics

40 Narratives

27 Best Practices

Pages: 109

Published: Pre-2013

Delivery Format: Shipped


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This Best Practices Benchmarking Report enables MTS operations functions to improve manufacturing processes and avoid costly product recalls and manufacturing shutdowns. With concerns about internal costs and an increased focus from regulatory authorities on data handling, computer system validation, and manufacturing review processes, manufacturing issues are taking center stage at leading pharmaceutical companies. As process owner, Manufacturing Technical Services (MTS) plays a key role in ensuring that safe and efficacious products reach the market by the most cost-effective methods possible.

Industries Profiled:
Pharmaceutical; Biotech; Health Care; Government

Companies Profiled:
AstraZeneca; Pfizer; Eli Lilly; GlaxoSmithKline; Merck; U.S. Food & Drug Administration

Study Snapshot

According to conservative estimates, as much as 25 percent of the costs of bringing a pharmaceutical product to market come from manufacturing expenses. By adopting optimal structures and strategies for Manufacturing Technical Services, companies can maximize resources while positioning the function as an improvement arm for processes across the supply chain. 

Manufacturing Technical Services (MTS) plays a critical role in ensuring that safe and efficacious products reach the market by the most cost-effective methods possible. During the manufacturing process, MTS is responsible for data handling, system validation, and manufacturing review processes, all of which -- if done well -- can avoid costly product recalls and facility shutdowns. 

This Best Practices Benchmarking® Report examines productivity and quality issues in a highly-regarded group of pharmaceutical companies' MTS functions. Best Practices, LLC researchers analyzed several issues, including the structure, training, and communications between corporate headquarters and manufacturing sites, metrics for the quality of staffing and practices within sites, predictive staffing models, as well as methods by which companies can review and evaluate new technologies for their contribution to manufacturing productivity. 

By studying other organization's best practices in Manufacturing Technical Services, your company can better understand how to structure and staff its MTS function, allocate staffing resources at various points in a manufacturing project, evaluate new technologies, and cultivate a sense of ownership by MTS for the entire manufacturing process. 

Metrics Included in the Study
Performance metrics enable executives to perform gap analyses and identify areas needing improvement. Metrics are an important complement to the qualitative best practices included in this study report. Best Practices LLC analysts collected and analyzed the following metrics for MTS at all companies benchmarked in the study:

  • Number of manufacturing plants (categorized by type: bulk, finishing, packaging, delivery) 
  • Number of MTS employees at corporate headquarters and manufacturing locations 
  • Educational background level of MTS staff 
  • Experience level of the company’s MTS staff ( in years) 
  • Importance ratings of MTS responsibility for the training and education of manufacturing employees 
  • Percentages of companies using control charting in all plants, some plants, or not at all 
  • Percentages of companies taking a proactive vs. reactive approach to developing technology 
  • Importance rating for using automation solutions for manufacturing efficiencies

Key Findings

Manufacturing Technical Services plays a significant role in the costs and timelines involved in bringing pharmaceutical products to market. As such, Manufacturing Technical Services leaders seek to understand the key drivers affecting MTS’ ability to deliver cost-effective, efficacious, and safe manufacturing processes that meet or surpass regulatory standards. Throughout research with the benchmark class, Best Practices, LLC analysts identified three critical success factors used by industry-leading MTS functions: implementing successful structures and reporting relationships, forecasting appropriate staffing levels, and using innovative technology. Therefore, the top three recommendations from this study are to: 
  • Balance corporate oversight with local site stewardship to create effective Manufacturing Technical Services roles – This report shares best practice findings that detail strategies and structures that benchmark partners use to align performances between corporate headquarters and manufacturing sites. The report details six company structure profiles, including common elements such as a corporate MTS group, site stewardship, and a knowledge management infrastructure. The report discusses tactics used for maintaining a lean manufacturing environment, recommends which responsibilities should remain at the corporate or site levels, and reviews how to prepare for the manufacturing needs of new products during product development. Other best practices include how corporate headquarters and sites can best communicate in site visits, meetings, and through the Internet. 
  • Use staffing models and historical data to budget for new hires during the annual planning process – This report describes how companies use models to predict staffing requirements throughout a project. The report details examples of how companies determine current staffing capabilities, such as how many products each plant scientist can oversee. Other best practices include the methods and timing of allocating staff by products, and forecasting future staff needs using databases and zero-based budgeting. 
  • Develop proactive methods to handle the increased speed of technological advancement - A third finding from the benchmark study includes practices on how companies track, review, and evaluate technology to determine which technology will improve process efficiency and quality, thereby increasing company profitability. Other best practices include building benefits cases, establishing cross-functional teams, and implementing new technologies in pilot programs or new product processes to avoid disrupting existing processes. Practices focus on three major categories of new technologies: in-process analytics, automation, and information technology. 
Table of Contents

Executive Summary 
  • Lessons Learned
  • Top Challenges

Structure, Roles and Responsibilities 
  • Company Structure Profile
  • Setting Roles and Responsibilities

Staffing, Career Development and Training 
  • Forecasting Staffing Needs

List of Charts & Exhibits

Benchmark Partner Lessons Learned Matrix
Benchmark Partner Top Challenges Matrix
Total Manufacturing Employees
Manufacturing Staff per Production Site
Manufacturing Technical Services Responsibilities
Manufacturing Technical Services Staffing
MTS Staff at Corporate Headquarters
MTS Staff across all Manufacturing Locations
MTS Staff per Manufacturing Location
Plant MTS Staff per Corporate MTS Staff
Total Manufacturing Staff per MTS Staff
MTS Staff Educational Background
MTS Staff Tenure
MTS Staff Scheduling
Using MTS Employees for Training
Logging Data During Manufacturing
Control Charting
Approach to Developing Technology
Automation Frequency
MTS Survey Matrix
Technology Experts Responsibilities
New Products vs. Existing Products
Local MTS Tasks
New Product Introduction Team
Communication Across Sites
Staffing Rule of Thumb
Staffing by Products
Staffing for New Products
Tracking Project Time
Key Outsourcing Reminders
Career Path
Tracking New Technologies
Introducing New Technologies
New Product Manufacturing Rollout
Effect of In-Process Controls
Considering Electronic Batch Records
Periodic Product Quality Investigations
Documenting Process Deviations
Global Supply Structure
Manufacturing Operations Structure
Global Process R&D Structure
Escalation of Process Issues
Site Technical Support Structure
Deviation Management System
Distribution of MTS Tasks
Breakdown of Site Staffing
Project Review Board