I ssue No. 2: Retraining for a Career in Big Pharma

Question:

Dear Advisor,I am among those graduates who just missed the boat for Singapore's recent initiative in the biomedical sciences. During my undergraduate days, there were no such choices as pharmaceutical technology, biomedical sciences, or biomedical engineering.Now, with an "old" traditional B.Sc. degree, I feel very disadvantaged. I want to be part of the new engine of growth, i.e., be involved in the biomedical sciences or the medical devices, biotechnology, or pharmaceutical sector. My preference is a career in pharmaceutical manufacturing.I have been working as an event manager for more than 3 years now. I also hold a diploma in business management. I have only limited knowledge of the pharmaceutical sciences.My question: Is it possible for me to retrain myself for the pharmaceutical industry on a part-time basis while still retaining my current job? If so, where could I receive training, and roughly how long will it take?Last, do you think it is possible and better for me to resign from my current job and take up any job in the pharmaceutical industry first and then start learning on the job?Sincerely,Chin Wee

Answer:

Dear Chin Wee,

I think I can understand your feelings quite well, because I am in a similar situation. Although I have been working in the pharmaceutical business for more than 15 years, for all of those years I have been nurturing an ambition to become a professor and to study and teach history. I am particularly interested in researching the trading and mutual cultural influences between the Roman and the Chinese worlds in the 1st to 4th centuries A.D.; however, I have never quite managed to pluck up the necessary courage to pursue this ambition.

From your letter, I understand that you are rather impressed by the shining and brilliant prospect of the biomedical industry. But is your interest generated by TV news, documentaries, and articles or by sharing experiences with relatives or friends in the business? I ask because every time I read an article or watch a program on the pharmaceutical industry on TV, I find myself wondering if I am working in that same world--so exciting and high-tech. Please do not misunderstand me: The pharmaceutical industry is interesting and challenging. But it is not some kind of Star Trek heaven--where a young, brilliant researcher with a bright idea today can save her old grandfather from dying of lung cancer 6 months later--as it is frequently portrayed by the media.

On average, it takes 10 years to develop a single new medicine, and out of every 100 new molecules that enter Stage 1 (the first stage of development registered with regulatory bodies, such as the FDA in the United States, EMEA in Europe, or HSA in Singapore), the number of new drugs that will be approved can be counted on the fingers of a single hand. I personally know some very bright scientists who, having worked for more than 20 years in big pharma, have had no new drug approved in their careers. For various reasons, all their projects were stopped at different stages, from the first toxicological studies to just before their submission to FDA. So, to work on the discovery of new drugs can be exciting, but it is very frustrating, too.

In your letter, you mention that you are interested in manufacturing. Let's consider young chemists or chemical engineers at the beginning of their careers, with starting annual gross salaries of about SG$40,000, working as plant chemists or process engineers. In their first years, they will analyze production data, study small modifications to the plant--such as installing a different pump for feeding the centrifuge or a new condenser for the distillation column or performing the Installation Qualification, Operational Qualification for a new piece of equipment.

After 2 to 3 years, if they are really good, they will be promoted to senior process engineers, with a salary of about SG$55,000 and basically the same job, but with more autonomy and more responsibilities. They might start to write validation master plans for some very simple new equipment, such as a mill or a dissolution vessel, and could lead some small projects with budgets of SG$10,000 to SG$20,000.

At this point, it will be another 2 to 3 years in this same position before they will be able to move their careers in new directions, based on a combination of their technical and people/managerial skills. These are likely to be lateral moves, perhaps including stints in the quality-control department or in engineering. If they are really very good technically and at managing people (and they do not change employers too often, let's say no more than two or at most three times), after about 12 to 15 years, they will be promoted to plant managers, the most exciting and most demanding jobs in the pharmaceutical manufacturing industry. They will be responsible for 30 to 100 people, a plant whose replacement value is about SG$100 million, and the manufacture of active ingredients that cost about SG$50 million per year to produce. They will bring in a gross salary of between SG$100,000 and SG$150,000, and they will spend many weekends solving production problems in the plant or preparing presentations for the next big boss visiting the site. They will be happy in their jobs, but they would like to have more time for their interests and their family and, perhaps, rather fewer responsibilities for and commitments to meeting the annual company targets.

Let's come to your specific case. My guess is that you are very good at what you do, if you have managerial responsibilities after only 3 years. But your technical suitability for the pharma industry is clearly low, and you will need some retraining if you wish to stick to your stated goal. My first suggestion is to invest a couple of months' worth of your free time to figure out whether the biomedical industry can live up to your dreams or if your perception of it is itself a dream without a strong connection to reality. Try to talk with some people working in the industry, perhaps some old university colleagues who are now working in big pharma. Look on the Internet and on the Web sites of the companies that look interesting to you: Usually, they have a corner for job openings with much information about their activities. Also peruse the Web sites of professional associations, such as ISPE or PDA, and regulatory bodies such as FDA, EMEA, or HSA. Participate in one of the tours of pharmaceutical companies organized every year in Singapore by the Ministry of Manpower during the Learning Festival. And if you think that your idea today to improve the yield of that critical reaction can be applied tomorrow, this is not the right place for you. Your idea has to be formally described and reviewed by the plant manager, the quality operations manager, and the engineering manager; lab trials have to be performed and reviewed; a change control document must be written and approved; a Qualification Master Plan prepared; and then--and only then-- you can try your idea in the plant. If you do not like "bureaucracy" or, better, a rigorously disciplined approach to the work, where every operation must be described by Standard Operating Procedure and registered in a batch production record, your life will be quite tough.

After this investigation, you will be in a better position to understand if your interest in the pharma industry is serious or if it is simply based on the wrong impression. If you are still motivated, start to answer the job ads you find in The Straits Times and on the Internet. In 2003, the pharma industry in Singapore is expecting to hire roughly 400 people, so the number of openings will be quite consistent. Prepare yourself by reading Regulatory Guidelines on Plant and Process Qualification and Validation, Computer Validation, and 21 CFR part 11: You can find numerous documents on the FDA and EMEA Web sites, and these subjects are relatively new, with few real experts on them around. Being fluent in 21 CFR part 11 in a job interview could be a real asset. You could start attending a university course at night, but it is going to be time-consuming and expensive and will take a couple of years. Instead, spend 3 to 4 months answering job ads and studying in your free time before deciding to go back to school.

But first of all--my most important recommendation--do not neglect your current job. Do not decrease your commitment, do not underperform in your daily assignments as an event manager, and do not lose your focus on your present job. If, after some months of investigation and soul-searching, you reach the conclusion, as I did 15 years ago, that your current job is still the best, you will be more comfortable if your boss still has the same excellent opinion about your performance that he or she had 6 month ago.

Good luck. Whatever turns your career and life will take at the end of this period of learning and searching, you will have a better understanding of yourself.

A Pharma Insider