The Management of Chemical Process Development in the Pharmaceutical Industry (PDF)

Here is a practical guide that not only presents insights into the
organization and management of the disciplines involved in chemical
process development but also provides basic knowledge of these
disciplines, enabling process development practitioners to
recognize and assimilate them in their work. This book illustrates
practical considerations through many examples of the successful
direction and integration of the activities of chemists, analysts,
chemical engineers, and biologists, as well as safety, regulatory,
and environmental professionals in productive teams. Moreover, this
reference provides guidance on:

* Directing and carrying out specific tasks and courses of
action

* Making and communicating clear and achievable decisions

* Solving problems on the spot

* Managing the administrative aspects of chemical process
development

The author, Dr. Derek Walker, has directed chemical process
development work for four decades, combining firsthand chemical
synthesis experience with many other disciplines needed to create
chemical processes. You will benefit from his advice and unique
insights into:

* Understanding the workings of matrix organizations

* Defining missions and creating action plans

* Developing interdisciplinary approaches to problem solving

* Holding review meetings, revising goals, and motivating
staff

* Prioritizing programs and responses to emergencies

In addition, you'll learn how successful chemists, in
collaboration with other disciplines, define the best (green)
chemistry for process scale-up, including accommodating FDA
requirements in the last process steps and addressing safety and
environmental matters early in their work. Case studies provide
incisive perspective on these issues. A chapter on recognizing and
patenting intellectual property emphasizes the importance of
comprehensive literature surveys and understanding invention. A
chapter on the future challenges you to think beyond narrow
constraints and explore new horizons.