According to the National Science Board, biotechnology is one of the most active fields in research and attracts about a quarter of all funding from companies in the industry.1 The field originated in the 1970s as a result of the discovery of a new recombinant DNA technique by Stanley Cohen of Stanford University and Herbert Boyer of the University of California-San Francisco. The new method enabled them to make proteins in cultured cells under controlled manufacturing conditions. Since then, the industry has gone on to create more than 200 new therapies and vaccines, and has found applications beyond the medical field.2
Simply put, biotechnology is the use of organisms by humans. In that sense, biotechnology is not an entirely new field. For example, humans have been cloning plants for centuries. Today, biotechnology is reaching past physical manipulation at a visual level and onto the molecular level. In modern biotechnology, scientists physically select the desired characteristic at the molecular level and alter the organism's genetic makeup.3
While traditional science has always "manipulated" organisms to the advantage of the human race, biotechnology uses biology, chemistry, physics, engineering, computers and information technology to manipulate life and genetic materials at the atomic level,4 and this has raised many ethical questions. As biotechnology is a relatively new science, its long-term consequences are unknown, and the industry continues to cause controversy due to social and ethical questions about biotechnology research, product development and commercialization.5 For example, President Bush has prohibited the cloning of humans, and has severely restricted stem cell research to pre-existing stem cell lines. Similarly, the popularity of organic and all-natural products has been largely a result of the backlash against biotechnology.
Because of all these factors, work in biotechnology is exciting, groundbreaking, highly profitable but also controversial. In the private sector, biotech firms are often quite small, employing 50 or fewer employees. Because the development of biotech products can take more than a decade and require hundreds of millions of dollars in research, biotech firms are often dependant on investor funds for cash flow, and hold intellectual property (typically patents) as assets.6 Consequently, biotechnology is truly an industry of ideas.
Who Biotechnology Serves:
Biotechnology has applications in nearly every field affecting the basic needs of human and ecological life:
- Crop biotechnology (production improvement)
- Forest biotechnology
- Animal biotechnology (includes applications for human medicine and livestock production)
- Food biotechnology (improving the raw materials, food processing)
- Industrial sustainability
- Green Plastics
As biotechnology continues to grow and break new ground, new applications will emerge.7
What They Do:
The basic consumer applications of biotechnology are pharmaceuticals and chemical and material sciences. Pharmaceutical research and development results in the discovery of new drugs, antibiotics and vaccines to treat or prevent health problems, while chemical and materials science research and development focuses on creating new molecules and materials with properties useful to humans. Biotechnology impacts these industries by allowing better models of biochemical processes and more efficient testing of products.8
Areas of specialization in biotechnology include research and development, production, quality control/assurance, and administration.
Research and development, or R&D, is the organizational unit that finds ideas for products, and performs research and testing to see if the ideas are feasible.9 The most fundamental work in biotechnology is done by biochemists, who study the chemical and genetic composition of living things. In order to manipulate the complex chemistry of an organism, biochemists must first understand the combinations and reactions involved in metabolism, reproduction and growth.10
Once that understanding is achieved, new products and methods can be developed. Responsibilities of this unit include:
- Finding potential products with commercial value and characterizing the properties of that product;
- Establishing product specifications and developing test methods to ensure that the product meets those specifications;
- Developing processes to make the product;
- Determining the raw materials and equipment required to make the product; and
- Developing a production plan for the product.11
The production unit is responsible for making the products provided by the R&D team. The systems and methods used for biotechnical production are diverse, including growing bacteria and cells, cultivating crops, and maintaining laboratory and farm animals. Responsibilities of the production unit include:
- Working with large-scale equipment and large-volume reactions;
- Monitoring and controlling the environment and processes required for the product; and
- Initiating corrective actions if problems arise.12
The quality control/quality assurance (QA/QC) unit ensures the quality of the product, with quality control specifically responsible for monitoring processes and performing laboratory testing. This unit monitors the equipment and personnel, as well as testing samples of the finished product. Most importantly, this team decides whether the product meets the standards required for release to the public.13
Finally, the administrative unit handles marketing and delivery of the product to the public. This includes marketing, market research, technical writing, and project management. In the academic research setting, this also includes grant and summary writing.
Biotechnology is a growing and lucrative field. During the past ten years, the number of biotech employees has increased by more than 90%.14 The average annual wage of U.S. bioscience workers was $65,775 in 2004, more than $26,000 greater than the average private sector annual wage.15
What Employers Want:
Employers are looking for both a strong academic background and real world experience investigating and solving problems, either through academic projects and extra-curricular activities, internships or university-level research experience.16 Ideal undergraduate majors at Hopkins would be biomedical engineering, chemical & biomolecular engineering, materials science & engineering, biophysics, and the sciences. Graduate degrees are expected for upper level positions.
What They Hire Undergraduates to Do:
Entry-level positions are available in most aspects of biotechnology, in both the private sector and in clinical research.
&n'Recent graduates interested in research and development can pursue positions as Research Assistants, which require bachelor’s degrees but not extensive professional experience. Higher-level scientist positions require doctorates.
In quality control/assurance, entry-level positions are available as Quality Control Analysts, who conduct routine analysis of raw materials as well as special projects involving analytical problem solving. Quality Control Engineers are responsible for developing and maintaining quality standards, and Safety Specialists evaluate conditions and production processes within the company.17
Entry-level positions with the production unit are available as Product Development Engineers, which handle the design, development and enhancements of existing products and processes; Process Development Associates implement their suggestions. Production Planners schedule and coordinate the final approval of products throughout the production cycle and communicate with the administrative team.
On the administrative side, technical writers write and edit standard operating procedures in addition to insuring regulatory compliance. Technical writers must have a thorough understanding of both biotechnological science and communications.18 Similarly, Regulatory Affairs Specialists prepare documents for submission to regulatory agencies and recommend strategies for earliest possible approvals of clinical trial applications.
In clinical research, biotechnology scientists are working toward the treatment of a disease rather than a profitable product. This allows for more freedom, but also results in considerably less pay. Many biotechnology professionals begin in clinical research and then later move to the private sector.
Recent graduates in clinical research facilitate the research process, typically before or while pursuing graduate degrees. Clinical Programmers are responsible for coordinating and monitoring the flow of clinical data into databases, analyzing the data, and resolving inconsistency problems within the data. Clinical Research Associates are responsible for designing, planning and implementing clinical research projects. Technical writers assist in grant proposals and research papers.19
Geraldine Peterson- Vice President, Regulatory Affairs, Garvey Associates B.A., Biology, 1976
- How did you get interested in your field? Was it your original goal when you started at Hopkins? - Yes, originally in nursing.
- What was your career path? How did you get to where you are today? - I worked for years in nursing in various positions then did a major in health services and policy. I began in my job because of my "business" training and medical experience.
- What was your first job after college? Was it in your current field? - Emergency department nurse. No, not in my current field.
- What advice do you have for current students? - Study what you love and be open to new experiences. You have a lot of years of working and careers often develop in serendipitous ways.
- What is your typical day like? - I work in a very small firm. I check with our president and the secretary about anything that may be happening that I'm unaware of, check email (usually every hour), check FDA updates, continue working on article reviews, document reviews, online searches as necessary. Usually a teleconference with at least one client to discuss progress or issues with a project.
- What’s most rewarding about your industry and/or job? What's most challenging? - Rewarding: Problem solving. Challenging: Problem solving--along with delivery of often discouraging news to clients.
- What are typical entry-level positions for this field? What tips do you have for students to be successful in these positions? - Regulatory assistant. Ask to do or participate in all aspects of the regulatory process. Be detail oriented.
- Where do you see the field going in the next 5-10 years? - Drug regulatory affairs will be even more globally technically oriented.
- What skills and out-of-class experiences are ideal for entering your industry / career field? - Basic science or clinical background is a good foundation for the field.
- Where can someone in an entry-level position expect to be in two years? Five years? Ten years? - After two years in a very large firm, still as assistant, after five years, a manager, after ten years, a senior manager--in a smaller firm, after ten years, a vice-president.
- Which professional organizations and resources should students look into or get involved with? - RAPS-Regulatory Affairs Professional Society and DIA-Drug Information Association.
Theodore R. Carski- Corporate Medical Director, Becton Dickinson and Co. (Retired) Chemistry, Class of 1952, M.D., 1956
- How did you get interested in your field? Was it your original goal when you started at Hopkins? -
Parental influence (father was a chemist) Entered as pre-med, graduated as pre-med with acceptance to med school.
- What was your career path? How did you get to where you are today? - Military deferment during school and internship then US Public Health Service for 3 years. Then R&D job with Becton Dickison. Promotions and increasing responsibility over 34 years with same company.
- What was your first job after college? Was it in your current field? - Medical school immediately after college.
- What advice do you have for current students? - Get your parents money's worth. Sit in the front of the classroom. Participate and learn all you can. Get the best grades possible. Might not be fun but it will be worth it in the long run.
- What is your typical day like? - No typical day. Variety of domestic and foreign travel, scientific and company meetings, preparation of publications, interface with employees, government authorities and customers.
- What’s most rewarding about your industry and/ or job? What's most challenging? - Rewarding: Responsibility for quality of products that improve the health of the world - with income that provided a comfortable life for my family. Challenging: Unsolved medical and scientific problems.
- What are typical entry-level positions for this field? What tips do you have for students to be successful in these positions? - Stay in school as long as you can. If you must work go to school part time. Get advanced degrees. Always tell the truth.
- Where do you see the field going in the next 5-10 years? - Medicine and science are here to stay. Both will continue to provide opportunity and growth.
Aileen I Velez Cabassa- Quality Control Analyst, Lonza Walkersville Inc. Biology Class of 2000, M.A. Biotechnology
- How did you get interested in your field? Was it your original goal when you started at Hopkins? - No. Originally I wanted to go into the medical field but fell in love with the molecular aspect of bio when I took my first genetics class.
- What was your career path? How did you get to where you are today? - From laboratory research at VCU to research at Hopkins to now quality control at Lonza and looking to enter the RA field next.
- What was your first job after college? Was it in your current field? - Laboratory research associate at VCU/MCV.
- What advice do you have for current students? - I would encourage them to enter an internship or co-op in whatever field they wish to enter.
- What is your typical day like? - Of course check messages. Depending on the schedule I am either attending meetings and/or performing test on our cell therapy products.
- What’s most rewarding about your industry and/or job? What's most challenging? - Knowing that I am at the cusp of the biotech field since I currently work testing cell therapy products currently in phase I & II. These products will save lives....Challenging; Making the move now from Quality Control to Regulatory Affairs now.
- What are typical entry-level positions for this field? What tips do you have for students to be successful in these positions? - Again, you need to have worked in a lab at some capacity prior to graduation.
- Where do you see the field going in the next 5-10 years? - We're here to change the world..... We will be able to treat cancer and other diseases.
- Where can someone in an entry-level position expect to be in two years? Five years? Ten years? - In two, you might train others. In five, you can work to become a supervisor or become a specialist. You may need more than a BS thus continue to further. In ten, either working on your PhD to stay in research or learning of the many other fields open in the biotech industry and move in one of those directions. I choose to move towards RA.
- Which professional organizations and resources should students look into or get involved with? - Regulatory Affairs Professional Society (RAPS) if your interest in RA; I am currently a member. But while at JHU join the Hopkins Biotech Network (HBN) of which I am also a member.
Additional Alumni Profiles
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Industry /Professional Organizations:
Networking with professionals who work in this field can help you learn very specific information about a career field. Professional contacts through professional associations, faculty, friends and family can be very helpful. You may also explore career opportunities by talking with employers at career fairs, and company presentations.
Internships - research positions and summer employment are highly effective ways for you to try out a field, gain experience and skills and make professional contacts.
If you would like to talk about how your search is going, we invite you to make an appointment with a Career Counselor by calling 410-516-8056.