Preface

Everyone is a Scientist and a Manager

A competent analytical scientist in a fast-paced pharmaceutical product development project team should be an expert in analytical chemistry. This analytical scientist should also have a more than cursory understanding of organic chemistry, physical chemistry, and statistics. Moreover, to play a leadership role in developing a new medicinal product that is chemically stable, the analytical scientist should be knowledgeable in formulation technologies, manufacturing processes and practices, and packaging materials and configurations. Last but not least, since the analytical scientist is responsible for the testing results and data integrity, he/she should understand the regulatory strategies and requirements, quality assurance demands, and compliance obligations.

However, being technically competent does not automatically land the analytical scientist on a leading role in the industry. Good scientists are not necessarily good team players by training. For instance, a scientist who has gone through Ph.D. studies is most likely honored with a doctorate by the uniqueness of his/her research, by his/her independence or self-sufficiency, and not necessarily by how much he/she can collaborate with other fellow students. Instead of following other people's directions or suggestions, a scientist may take pride in being able to solve puzzles on his/her own. In the case of an analytical scientist, whose nature possibly is very much detail-oriented, he/she can become so attracted by details and gets lost in the weeds. The analytical scientist may forget that the entire project team is waiting for the data, while he/she is working hard trying to separate two impurity peaks on a chromatogram, or, is working hard to sort the data in a flawless format before sharing the results with the team.

To move career upward, scientists should recognize that in industry, every scientist has to be a manager.

There is a common misunderstanding of what a manager is. When you ask a laboratory bench scientist if he/she is a manager, the answer is often something like: "No, I am not a manager because no one reports to me." Quite oppositely, the answer should be: "Yes, I am a manager." A manager does not always mean a person who guides people. Regardless of whether having responsibilities for people, a person has a lot of relationships to manage at a workplace. As a member of a project team, a scientist needs to consciously manage working relations with the immediate teammates, with colleagues from other teams or departments, and probably with the clients from external companies. Those relationships are all different depending on the roles, responsibilities, and positions. Therefore, in order to manage project activities well, regardless of whether he/she has people management responsibility, the scientist should pay attention to manage those different working relationships. One important note here is, however, that the aspect of management in this book is not regarding people management or team building. It is about task management. The professional working relationships should be managed based on the understanding of each other's work, by effective and efficient execution of responsible tasks, and by competently delivering satisfactory results. An analytical scientist should manage the analytical development tasks based on (1) a strong and broad knowledge of science, (2) a fair recognition of the obligations other departments have, and (3) a clear understanding of the impact the analytical development work on the operation of other team members or functions. As a leader in a project team, the analytical scientist should be able to see the big picture while paying attention to details, and has to manage the work priorities appropriately, keep timelines in mind, and meet project deliverables. Scientists all have curiosities, and that makes them good scientists. However, in industry, respecting project/task timelines is equally important as to following curiosities. Being able to balance the desire of pursuing scientific curiosity versus the duty of moving projects forward with results that are not perfect but acceptable, is a valuable skill for an analytical scientist to possess. Continuous improvement is an essential part of the life cycle management of a product, an analytical method, and a work process. Furthermore, besides knowing the importance of managing the working relations and managing tasks in hand, to effectively work with the co-workers, the scientist should be able to conduct effective communications; be able to articulate his/her thoughts, ideas, or rationales; be good at storytelling; and is willing to help establish a trustworthy, safe, less stressful working environment. All the above-mentioned aspects are part of a managership that a scientist should possess. In that sense, everyone is a manager.

In summary, a true leader in a product development environment should have solid scientific expertise and necessary soft skills to manage projects and activities. Only when scientists apprehend that they are on the path of product development together with other colleagues, where their work is affected by the workflow from the upper stream and their work also impacts the downstream team members or functions, can they become good team players or true leaders.

There are many books specializing in analytical chemistry, organic chemistry, liquid and gas chromatography, pharmaceutical product degradation chemistry, pharmaceutical product formulation, process technology, statistics for analytical scientists, interpersonal and communication skills, time management, project management, etc. Those books provide in-depth knowledge and serve as good tool books. However, sometimes it is not an easy task for a scientist who does not have a strong educational background in those specific fields to comprehend all the contents of the books. Sometimes people are looking for a quick answer to the question they have or the issue they encounter during their daily work, and do not have sufficient time to do in-depth learning of something they did not learn in school. A book that provides practical knowledge and insights that are sufficient for one to become a well-rounded scientific leader, a book that covers broad but critical aspects in analytical development, is much needed. The potential readers are Analytical Chemists, Pharmaceutical Scientists, Regulatory Affair Specialists, Graduate School Students in Chemistry related fields, Project Managers, Laboratory Managers, Consultants, and Business and Marketing coworkers who are interested in having some technical conversations with scientists.

Analytical development is a broad concept. Different companies, different product categories (e.g., prescription medicines, over-the-counter (OTC) medicines, nutritional products, dietary supplements, herbal medicines or phytomedicines), and different medicinal product development stages can have or request vast different organizational settings. The roles and responsibilities of the analytical scientists can be quite different between teams, departments, and companies. Not every analytical scientist can have an opportunity to experience product development from conceptual molecules to product commercialization. I have been working in a consumer health product development environment and have the opportunity to witness the majority of the process for the development of an OTC medicinal product.

Writing this book is largely based on the desire of sharing my learning. It is not intended to turn it into a textbook-like reading experience. I hope the contents of the book are interesting to read and are practically useful to the readers. The learning that I am sharing in this book is certainly not gained solely through my own thinking. I am forever grateful that ever since my childhood, I have been able to have friends, classmates, teachers, mentors, and colleagues that are kind, talented, devoted to their study, research and work, and open to share their knowledge. I spent my undergraduate years at Wuhan University, which has the most beautiful campus and is one of the top universities in Chemistry in China. During my Ph.D. study in the Analytical Chemistry Laboratory of Professor Yoshio Umezawa at The University of Tokyo (Japan), I was able to learn from the world-class researchers: Dr. Philippe Bu¨hlmann, Dr. Sugawara Masao, Dr. Tohda Koji, and Dr. Seiichi Nishizawa. There I began to understand the true meaning of hard-working from doing research together with the students and professors behind the Akamon (Red Gate), the symbol of this broadly respected as the top institution of undergraduate education and graduate research in Japan. The research topic, Molecular Recognition, enabled me to see the chemistry at the molecular level and allowed me to conduct a fair amount of organic synthesis. One of the compounds that I synthesized about 25 years ago is still being sold by several well-known chemical merchants. Although I was granted fellowship of the Japan Society for the Promotion of Science at the end of my Ph.D. study, for some reason I chose to come to the United States and began my postdoctoral research in Professor Merlin Bruening's laboratory at Michigan State University. There I learned the surface modification, synthesis, and characterization techniques. Two years later, I transferred to the University of Michigan to pursue my second postdoctoral study under the guidance of Professor Mark E. Meyerhoff. In his laboratory, the team studied various nitric oxide-releasing hydrophobic polymers that have potential applications as...