Interview with a Thought Leader in Analytical Chemistry

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1 Interview with a Thought Leader in Analytical Chemistry Stephen T. Colgan, Ph.D. By Poonam Delvadia Ph.D. Candidate AAPS APQ Student Representative Graduate Student (Biopharmaceutical Analysis), Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University, Richmond, VA Stephen T. Colgan, Ph. D., has served at various positions and gained versatile experience in Analytical Chemistry. Dr. Colgan is working for Pfizer Inc. for more than 25 years. Dr. Colgan is the chairperson of the AAPS APQ section for the year The following is an interview giving his expert advice to students interested in pursuing a career in analytical chemistry. PERSONAL QUESTIONS 1 What is your educational background? BS in Chemistry, S.U.N.Y. Cortland MS in Forensic Chemistry, Northeastern University PhD Analytical Chemistry, Northeastern. University 2 What attracted you to analytical chemistry? I started out as a Biology Major, but that seems to require a lot of memorization. Chemistry focused more problem solving which I was better suited for. My undergraduate advisor at Cortland was a physical and analytical chemist my 1 st research was on the study of bile salt micelles which employed a lot of GC work. I liked it then and stuck with it. I also worked one summer at the University of Rochester doing synthetic organic chemistry. That confirmed that I preferred analytical chemistry. 3 What attracted you to pharmaceutical industry? I originally thought that I wanted to be a forensic chemist, but an internship at a city crime lab changed my mind. My research advisor at Northeastern had a number of contacts in PhRMA and he put me in touch with one of his collaborators who I still work with at Pfizer. In the late 1

2 1980 s when I graduated, the pharmaceutical industry was the place to be interesting work with generous compensation. 4 What is your proudest moment as an analytical chemistry professional? I have always supervised a small group and have migrated through several disciplines during my career. My proudest moments are when the colleagues I have been directing are successful (and proud of themselves). An example of this would be successfully running a meeting with the FDA or EMA followed by approval of a much needed drug. ANALYTICAL CHEMISTRY QUESTIONS 5 How does analytical chemistry contribute in overall drug product development? Analysts are part of a larger team that: Develops/delivers the API, DP, and regulatory filings. They do not just deliver data, they help guide the project team to the larger deliverables 6 What analytical technologies involved in raw material (ex. API, excipients, packaging components) evaluation? LC, GC, MS, IR, RAMAN, UV, NMR, X-ray, particle size analysis, Karl Fischer, thermal techniques, etc. 7 What is the most attractive feature of analytical chemistry that set it apart from other disciplines in the industry? I wouldn t say that analytical chemistry is more attractive than the other disciplines I think it is more a matter of personal preference. 8 From your perspective, what makes analytical chemistry different from forensic chemistry? A forensic chemist uses a variety of analytical techniques, but others as well (finger print identification). A forensic chemist will need to appear in a court of law on a regular basis so being comfortable and persuasive in a hostile environment is a necessity for a forensic chemist. Analytical and forensic chemists both need to demonstrate integrity, teamwork, the ability to solve problems and to effectively communicate to subject matter experts and people less familiar with their disciplines. 2

3 9 Are there different subsections under Analytical Chemistry in Pharmaceutical Industry? What type of analytical expertise each subsection requires? There is some specialization (e.g. mass spectrometry) but there are analytical generalists as well. The ability to solve problems/puzzles is needed for all situations. Some companies will have their analysts focus on either the drug product or API (but not both). In smaller companies, analysts will tend to do both. Smaller companies also will tend to have their analysts perform activities related to method development and GMP releases while larger companies may divide these activities into different groups. QUESTIONS FOR STUDENT ADVICE 10 What are basic qualifications required to become an analytical chemistry professional? I would think that a BS in chemistry or closely related field would be the minimum educational requirement. With a tight job market, lab experience as an intern in academia or industry would be highly desired. The ability to work in a team environment is a must. Excellent communication skills (written, oral, , etc) also are needed. Since the field is constantly evolving, the ability to learn and adapt to new working arrangements and new techniques also would be required. 11 What advice would you like to give students interested in pursuing a career in analytical chemistry? Try different things. Use your time in the summer and during the school year to explore working in different environments. Get involved in research I published 3 papers as an undergraduate and continued to publish in graduate school and in industry. I was not involved with the AAPS as a student, but I would recommend using the AAPS or similar organizations to learn and to network. 12 What job search advice do you have for recent graduates? Networking is very important. Your advisor probably is the best place to start. A PERFECT resume and cover letter are needed (although I hear that these are becoming archaic). When you land an interview, make sure you have done your research about the company and make sure you have pre-determined questions. You should have practice interviews this is very important and you should be prepared to answer typical and atypical 3

4 questions. I would recommend a demeanor that is confident but humble. During the interview, make sure you are actively listening. 13 What advice would you pass on to students on networking? Remember that it is a very small world you would be surprised how often you run into the same people. Think long-term and remember that nothing is more valuable than your reputation. When you network, it usually is in support of some type of project. Do what you have committed to do and stay transparent with your colleagues. 14 What should students focus on outside of their course work to advance in their careers? Public speaking, effective writing, mentoring and public service. 15 How can students make themselves more valuable to potential employers? Keep learning, stay busy. 16 As an active AAPS APQ leader, what suggestions you have for students interested in analytical chemistry to gain benefits from the APQ section? There are local scientific meetings that would be fairly inexpensive to attend. Dial into webinars that are of interest to you. Remember that the AAPS has travelships that can be used for student travel. 17 What would you suggest to keep up with advancement in analytical technologies? Recognize that you can t keep up with everything. I would recommend finding a niche that is of interest to you and concentrate on that. 18 Does a fresh graduate who has recently joined industry get an opportunity for publication? A fresh graduate should concentrate on learning to deliver for the company. It often takes 6 12 months of learning before a new hire is fluent in their new responsibilities. In some situations/companies, there is no opportunity to publish regardless of tenure. There are companies who do encourage publication, but this can be considered outside of someone s normal duties and the work may need to be done after dayjob act ivies have been completed. That said, there are many people who do publish and it is my opinion that this actually improves a 4

5 person s ability to grow, innovate and in fact has a positive return on investment. 19 What other analytical technologies you would suggest student to get knowledge of in addition to HPLC and LCMSMS? It is my impression that gas chromatography and normal phase chromatography are underutilized these days so I would recommend those. Another lost art may be sample preparation especially when analyzing complex samples. I would recommend that students focus on sample prep before they worry about the end-analysis. I have found that many of the problems with an analytical method are actually a result of non-robust sample preparation. Students should also be aware that many laboratories do not have access to LCMSMS or other high-end techniques. A sample preparation approach that employs derivatization and/or preconcentration should be considered as these may negate the need for the more expensive (and perhaps less robust) analytical techniques. 5

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