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Career Story: Director Of Manufacturing For A Biotech Firm

Director Of Manufacturing For A Biotech Firm

Job Title: Director Of Manufacturing

Type of Company: I work for a small biotechnology company based in Framingham, Massachusetts. We produce human therapeutic drugs using transgenic animal production systems.

Education: BS, Biology and Costal Zone Ecology, Southeastern Massachusetts University (North Dartmouth, MA)

Previous Experience: After having difficulty breaking into the marine biology research field, I took a position with an early biotechnology company manufacturing monoclonal antibodies for commercial and R&D purposes. After 2 years there I moved to another biotech company where I advanced in manufacturing and operations management. After 19 years of steadily increasing responsibility in operations management I moved back to a small-sized company in the same field.

Job Tasks: As Director of Manufacturing, I am responsible for all manufacturing activities performed at my company. Some of this work is outsourced to contract manufacturing organizations (CMO's), but even then I oversee the relationship between our company and these contract organizations. I negotiate contracts with them to undertake specific steps in the drug manufacturing process. I work as a project manager with project teams from both organizations that do the scheduling, technical transfer, manufacturing, product testing, troubleshooting, data collection and analysis, and all the activities directly related to drug manufacturing.

But we also perform some manufacturing activities in-house. We have a small manufacturing arm with two labs that produce and purify drugs for use in early-stage clinical trials. The manufacturing staff must be properly trained in good manufacturing practices and prepared for inspections from regulatory agencies like the US Food and Drug Agency. The drug industry is regulated by the FDA in the US and by other agencies elsewhere in the world.

As the head of a department I am also responsible for participating in the budgetary process. I oversee the spending associated with the manufacturing staff (salaries) as well as equipment and supply purchases and the planning process. I work as part of a senior operations management team which meets at regular intervals to discuss and prioritize a changing list of ongoing projects. These projects are constantly being modified shaped and modified based on test results. Some tests are chemical analyses, some involve laboratory trials employing mice. Eventually, though, all our drugs have to be tested in human clinical trials before the products can be approved for commercial use.

Best and Worst Parts of the Job: The best part of my job is the satisfaction that I get from knowing that our products help save patients' lives all over the world. We get to hear real life stories of how we have saved or improved people's lives.

The worst part of my job is the travel that I have to do. I am often travelling between two sites and sometimes travelling overseas to contract manufacturing sites or to meet with potential clients or partners. I do not like to travel away from my family very much.

Job Tips: Get a thorough exposure to the biological sciences. Then take an initial entry-level position with a large biotech company that exposes you to various aspects of the business without compelling you to specialize. Once your resume contains several years of specialized experience it becomes more difficult to move around into different areas.

Additional Thoughts: I was always interested in science. I had thought about going into medicine but did not like the thought of several years of medical school at the time. The biotech industry is a strong area that I believe will continue to grow for many years. It is a field that has very gratifying careers in many different areas from bench research to sales and marketing. My advice is to contact and talk to many people in the field of your interest to understand what are the best steps to follow in order to follow a career path. For those looking to make a career change or someone who does not have a strong background in science, there are Biotech Certificate programs in several local community colleges which may be helpful in getting a start.

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