Pharmaceutical and Medicine Manufacturing

Nature of the Industry
The pharmaceutical and medicine manufacturing industry has
produced a variety of medicinal and other health-related products
undreamed of by even the most imaginative apothecaries of
the past. These drugs save the lives of millions of people from
various diseases and permit many ill people to lead normal lives.
Thousands of medications are available today for diagnostic,
preventive, and therapeutic uses. In addition to aiding in the
treatment of infectious diseases such as pneumonia, tuberculosis,
malaria, influenza, and sexually transmitted diseases, these
medicines also help prevent and treat cardiovascular disease,
asthma, diabetes, hepatitis, cystic fibrosis, and cancer. For example,
antinausea drugs help cancer patients endure chemotherapy;
clot-buster drugs help stroke patients avoid brain damage;
and psychoactive drugs reduce the severity of mental illness
for many people. Antibiotics and vaccines have virtually
wiped out such diseases as diphtheria, syphilis, and whooping
cough. Discoveries in veterinary drugs have controlled various
diseases, some of which are transmissible to humans.
Advances in biotechnology and information technology are
transforming drug discovery and development. Within biotechnology,
scientists have learned a great deal about human genes,
but the real work—translating that knowledge into viable new
drugs—has only recently begun. So far, millions of people have
benefited from medicines and vaccines developed through biotechnology,
and several hundred new biotechnologically-derived
medicines are currently in the pipeline. These new medicines, all
of which are in human clinical trials or awaiting FDA approval,
include drugs for cancer, infectious diseases, autoimmune diseases,
neurologic disorders, and HIV/AIDS and related conditions.
Many new drugs are expected to be developed in the coming
years. Advances in technology and the knowledge of how
cells work will allow pharmaceutical and medicine manufacturing
makers to become more efficient in the drug discovery process.
New technology allows life scientists to test millions of drug
candidates far more rapidly than in the past. Other new technology,
such as regenerative therapy using stem cell research, also
will allow the natural healing process to work faster, or to enable
the regrowth of missing or damaged tissue.
There is a direct relationship between gene discovery and
identification of new drugs—the more genes identified, the more
paths available for drug discovery. Discovery of new genes also
can lead to new diagnostics for the early detection of disease.
Among other uses, new genetic technology is being explored to
develop vaccines to prevent or treat diseases that have eluded
traditional vaccines, such as AIDS, malaria, tuberculosis, and
cervical cancer.
The pharmaceutical and medicine manufacturing industry
consists of about 2,500 places of employment, located
throughout the country. These include establishments that make
pharmaceutical preparations or finished drugs; biological products,
such as serums and vaccines; bulk chemicals and botanicals
used in making finished drugs; and diagnostic substances
such as pregnancy and blood glucose kits.
The U.S. pharmaceutical industry has achieved worldwide
prominence through research and development (R&D) work on
new drugs, and spends a relatively high proportion of its funds
on R&D compared with other industries. Each year, pharmaceutical
industry testing involves tens of thousands of new substances,
yet may eventually yield fewer than 100 new prescription
medicines.
For the majority of firms in this industry, the actual manufacture
of drugs is the last stage in a lengthy process that begins
with scientific research to discover new products and to improve
or modify existing ones. The R&D departments in pharmaceutical
and medicine manufacturing firms start this process
by seeking and rapidly testing libraries of thousands to millions
of new chemical compounds with the potential to prevent, combat,
or alleviate symptoms of diseases or other health problems.
Scientists use sophisticated techniques, including computer simulation,
combinatorial chemistry, and high-through-put screening
(HTS), to hasten and simplify the discovery of potentially
useful new compounds.
Most firms devote a substantial portion of their R&D budgets
to applied research, using scientific knowledge to develop
a drug targeted to a specific use. For example, an R&D unit may
focus on developing a compound that will effectively slow the
advance of breast cancer. If the discovery phase yields promising
compounds, technical teams then attempt to develop a safe
and effective product based on the discoveries.
To test new products in development, a research method
called “screening” is used. To screen an antibiotic, for example,
a sample is first placed in a bacterial culture. If the antibiotic is
effective, it is next tested on infected laboratory animals. Laboratory
animals also are used to study the safety and efficacy of
the new drug. A new drug is selected for testing on humans only
if it promises to have therapeutic advantages over drugs already
in use, or is safer. Drug screening is an incredibly risky, laborious,
and costly process—only 1 in every 5,000 to 10,000 compounds
screened eventually becomes an approved drug.
After laboratory screening, firms conduct clinical investiga-
Pharmaceutical and Medicine Manufacturing
(NAICS 3254)
SIGNIFICANT POINTS
• This industry ranks among the fastest growing manufacturing industries.
• More than 6 out of 10 workers have a bachelor’s, master’s, professional, or Ph.D. degree—twice
the proportion for all industries combined.
• Fifty-nine percent of all jobs are in large establishments employing more than 500 workers.
• Earnings are much higher than in other manufacturing industries.
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tions, or “trials,” of the drug on human patients. Human clinical
trials normally take place in three phases. First, medical scientists
administer the drug to a small group of healthy volunteers
to determine and adjust dosage levels, and monitor for side effects.
If a drug appears useful and safe, additional tests are
conducted in two more phases, each phase using a successively
larger group of volunteers or carefully selected patients, sometimes
upwards of 10,000 individuals.
After a drug successfully passes animal and clinical tests,
the U.S. Food and Drug Administration’s (FDA) Center for Drug
Evaluation and Research (CDER) must review the drug’s performance
on human patients before approving the substance for
commercial use. The entire process, from the first discovery of a
promising new compound to FDA approval, can take over a decade
and cost hundreds of millions of dollars.
After FDA approval, problems of production methods and
costs must be worked out before manufacturing begins. If the
original laboratory process of preparing and compounding the
ingredients is complex and too expensive, pharmacists, chemists,
chemical engineers, packaging engineers, and production
specialists are assigned to develop a manufacturing process economically
adaptable to mass production. After the drug is marketed,
new production methods may be developed to incorporate
new technology or to transfer the manufacturing operation
to a new production site.
In many production operations, pharmaceutical manufacturers
have developed a high degree of automation. Milling and
micronizing machines, which pulverize substances into extremely
fine particles, are used to reduce bulk chemicals to the required
size. These finished chemicals are combined and processed
further in mixing machines. The mixed ingredients may
then be mechanically capsulated, pressed into tablets, or made
into solutions. One type of machine, for example, automatically
fills, seals, and stamps capsules. Other machines fill bottles with
capsules, tablets, or liquids, and seal, label, and package the
bottles.
Quality control and quality assurance are vital in this industry.
Many production workers are assigned full time to quality
control and quality assurance functions, whereas other employees
may devote part of their time to these functions. For example,
although pharmaceutical company sales representatives,
often called detailers, work primarily in marketing, they engage
in quality control when they assist pharmacists in checking for
outdated products.
Working Conditions
Working conditions in pharmaceutical plants are better than
those in most other manufacturing plants. Much emphasis is
placed on keeping equipment and work areas clean because of
the danger of contamination. Plants usually are air-conditioned,
well lighted, and quiet. Ventilation systems protect workers from
dust, fumes, and disagreeable odors. Special precautions are
taken to protect the relatively small number of employees who
work with infectious cultures and poisonous chemicals. With
the exception of work performed by material handlers and maintenance
workers, most jobs require little physical effort. In 2003,
the incidence of work-related injury and illness was 2.8 cases per
100 full-time workers, compared with 6.8 per 100 for all manufacturing
industries and 5.0 per 100 for the entire private sector.
Only about 3 percent of the workers in the pharmaceutical
and medicine manufacturing industry are union members or are
covered by a union contract, compared with about 14 percent of
workers throughout private industry.
Employment
Pharmaceutical and medicine manufacturing provided 291,000
wage and salary jobs in 2004. Pharmaceutical and medicine manufacturing
establishments typically employ many workers. Nearly
60 percent of this industry’s jobs in 2004 were in establishments
that employed more than 500 workers (chart 1). Most jobs are in
California, Illinois, Texas, Indiana, New Jersey, New York, North
Carolina, and Pennsylvania.
Under the North American Industry Classification System
(NAICS), workers in research and development (R&D) establishments
that are not part of a manufacturing facility are included
in a separate industry—research and development in the physical,
engineering, and life sciences. However, due to the importance
of R&D work to the pharmaceutical and medicine manufacturing
industry, drug-related R&D is discussed in this statement
even though a large proportion of pharmaceutical industry-
related R&D workers are not included in the employment
data.
Occupations in the Industry
About 29 percent of all jobs in the pharmaceutical and medicine
manufacturing industry are in professional and related occupations,
mostly scientists and science technicians, about 18 percent
are in management occupations, another 12 percent are in
office and administrative support, and 3 percent are in sales and
related occupations. About 1 out of 4 jobs in the industry are in
production occupations, including both low skilled and high
skilled jobs (table 1).
Scientists, engineers, and technicians conduct research to
develop new drugs. Others work to streamline production methods
and improve environmental and quality control. Life scientists
are among the largest scientific occupations in this industry.
Most of these scientists are biological and medical scien73
tists who produce new drugs using biotechnology to recombine
the genetic material of animals or plants. Biological scientists
normally specialize in a particular area. Biologists and bacteriologists
study the effect of chemical agents on infected animals.
Biochemists study the action of drugs on body processes by
analyzing the chemical combination and reactions involved in
metabolism, reproduction, and heredity. Microbiologists grow
strains of microorganisms that produce antibiotics. Physiologists
investigate the effect of drugs on body functions and vital
processes. Pharmacologists and zoologists study the effects
of drugs on animals. Virologists grow viruses, and develop
vaccines and test them in animals. Botanists, with their special
knowledge of plant life, contribute to the discovery of botanical
ingredients for drugs. Other biological scientists include pathologists,
who study normal and abnormal cells or tissues, and
toxicologists, who are concerned with safety, dosage levels, and
the compatibility of different drugs. Medical scientists, who
also may be physicians, conduct clinical research, test products,
and oversee human clinical trials.
The work of physical scientists, particularly chemists, also
is important in the development of new drugs. Combinatorial
and computational chemists create molecules and test them rapidly
for desirable properties. Organic chemists, often using combinatorial
chemistry, then combine new compounds for biological
testing. Physical chemists separate and identify substances,
determine molecular structure, help create new compounds, and
improve manufacturing processes. Radiochemists trace the
course of drugs through body organs and tissues. Pharmaceutical
chemists set standards and specifications for the form of
products and for storage conditions; they also see that drug
labeling and literature meet the requirements of State and Federal
laws. Analytical chemists test raw and intermediate materials
and finished products for quality.
Science technicians, such as biological and chemical technicians,
play an important part in research and development of
new medicines. They set up, operate, and maintain laboratory
equipment, monitor experiments, analyze data, and record and
interpret results. Science technicians usually work under the
supervision of scientists or engineers.
Although engineers account for a small fraction of scientific
and technical workers, they make significant contributions
toward improving quality control and production efficiency.
Chemical engineers design equipment and devise manufacturing
processes. Bioprocess engineers, who are similar to chemical
engineers, design fermentation vats and various bioreactors
for microorganisms that will produce a given product. Industrial
engineers plan equipment layout and workflow to maintain
efficient use of plant facilities.
At the top of the managerial group are executives who make
policy decisions concerning matters of finance, marketing, and
research. Other managerial workers include natural sciences
managers and industrial production managers.
Office and administrative support employees include secretaries
and administrative assistants, general office clerks, and
others who keep records on personnel, payroll, raw materials,
sales, and shipments.
Sales representatives, wholesale and manufacturing, describe
their company’s products to physicians, pharmacists,
dentists, and health services administrators. These sales representatives
serve as lines of communication between their companies
and clients.
Table 1. Employment of wage and salary workers in pharmaceutical
and medicine manufacturing by occupation, 2004 and
projected change, 2004-14
(Employment in thousands)
Employment, Percent
2004 change,
Occupation Number Percent 2004-14
Total, all occupations ............................. 291 100.0 26.1
Management, business, and financial
occupations ............................................ 53 18.2 31.7
Top executives ........................................ 4 1.5 27.8
Marketing and sales managers ............... 4 1.3 34.1
Industrial production managers ............... 4 1.3 28.9
Natural sciences managers .................... 5 1.6 28.9
Managers, all other .................................. 5 1.6 28.9
Business operation specialists,
all other ................................................... 7 2.3 41.8
Accountants and auditors ...................... 3 1.0 28.9
Professional and related
occupations ............................................ 85 29.3 31.7
Computer systems analysts ................... 4 1.3 41.7
Industrial engineers, including
health and safety ................................... 3 1.0 28.4
Industrial engineering technicians .......... 3 0.9 29.1
Biochemists and biophysicists ................ 4 1.2 28.9
Microbiologists ......................................... 3 1.0 28.9
Medical scientists, except
epidemiologists ....................................... 10 3.5 41.8
Chemists .................................................. 14 5.0 23.6
Biological technicians .............................. 8 2.8 28.2
Chemical technicians ............................... 5 1.6 28.9
Sales and related occupations ............ 9 3.0 27.9
Sales representatives, wholesale and
manufacturing, technical and
scientific products .................................. 6 2.0 28.9
Office and administrative support
occupations ............................................ 34 11.6 14.5
Bookkeeping, accounting, and
auditing clerks ........................................ 2 0.8 16.0
Customer service representatives ......... 3 0.9 32.0
Production, planning, and expediting clerks 3 1.0 27.6
Shipping, receiving, and traffic clerks .... 3 1.1 16.7
Executive secretaries and administrative
assistants ............................................... 5 1.7 22.2
Secretaries, except legal, medical, and
executive ................................................ 5 1.7 8.5
Installation, maintenance, and repair
occupations ............................................ 13 4.5 28.8
Industrial machinery installation, repair,
and maintenance workers ..................... 10 3.5 28.9
Production occupations ........................ 79 27.0 21.6
First-line supervisors/managers of
production and operating workers ........ 7 2.5 28.9
Team assemblers .................................... 5 1.6 28.9
Chemical plant and system operators .... 3 1.0 28.9
Chemical equipment operators
and tenders ............................................ 8 2.6 28.9
Separating, filtering, clarifying,
precipitating, and still machine setters,
operators, and tenders .......................... 6 2.0 28.9
Mixing and blending machine setters,
operators, and tenders .......................... 8 2.7 28.9
Inspectors, testers, sorters, samplers,
and weighers ......................................... 8 2.7 16.3
Packaging and filling machine operators
and tenders ............................................ 22 7.6 9.8
Transportation and material moving
occupations ............................................ 13 4.4 20.2
Laborers and material movers, hand ...... 10 3.6 18.2
Note: May not add to totals due to omission of occupations with small
employment
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Most plant workers fall into 1 of 2 occupational groups:
Production workers who operate drug-producing equipment, inspect
products, and install, maintain, and repair production equipment;
and transportation and material moving workers who package
and transport the drugs.
Workers among the larger of the production occupations,
assemblers and fabricators, perform all of the assembly tasks
assigned to their teams, rotating through the different tasks rather
than specializing in a single task. They also may decide how the
work is to be assigned and how different tasks are to be performed.
Other production workers specialize in one part of the production
process. Chemical processing machine setters, operators,
and tenders, such as pharmaceutical operators, control
machines that produce tablets, capsules, ointments, and medical
solutions. Included among these operators are mixing and blending
machine setters, operators, and tenders, who tend milling
and grinding machines that reduce mixtures to particles of designated
sizes. Extruding, forming, pressing, and compacting
machine setters, operators, and tenders tend tanks and kettles
in which solutions are mixed and compounded to make up creams,
ointments, liquid medications, and powders. Crushing, grinding,
polishing, mixing, and blending workers operate machines
that compress ingredients into tablets. Coating, painting, and
spraying machine setters, operators, and tenders, often called
capsule coaters, control a battery of machines that apply coatings
that flavor, color, preserve, or add medication to tablets, or
control disintegration time. Throughout the production process,
inspectors, testers, sorters, samplers, and weighers ensure
consistency and quality. For example, ampoule examiners inspect
ampoules for discoloration, foreign particles, and flaws in
the glass. Tablet testers inspect tablets for hardness, chipping,
and weight to assure conformity with specifications. After the
drug is prepared and inspected, it is bottled or otherwise packaged
by packaging and filling machine operators and tenders.
Plant workers who do not operate or maintain equipment
perform a variety of other tasks. Some drive industrial trucks or
tractors to move materials around the plant, load and unload
trucks and railroad cars, or package products and materials by
hand.
Training and Advancement
Training requirements for jobs in the pharmaceutical and medicine
manufacturing industry range from a few hours of on-thejob
training to years of formal education plus job experience.
More than 6 out of 10 of all workers have a bachelor’s, master’s,
professional, or Ph.D. degree—twice the proportion for all industries
combined. The industry places a heavy emphasis on
continuing education for employees, and many firms provide
classroom training in safety, environmental and quality control,
and technological advances.
For production occupations, manufacturers usually hire inexperienced
workers and train them on the job; high school graduates
generally are preferred. Beginners in production jobs assist
experienced workers and learn to operate processing equipment.
With experience, employees may advance to more skilled
jobs in their departments.
Many companies encourage production workers to take
courses related to their jobs at local schools and technical institutes
or to enroll in correspondence courses. College courses in
chemistry and related areas are particularly encouraged for highly
skilled production workers who operate sophisticated equipment.
Some companies reimburse workers for part, or all, of their
tuition. Skilled production workers with leadership ability may
advance to supervisory positions.
For science technician jobs in this industry, most companies
prefer to hire graduates of technical institutes or community
colleges or those who have completed college courses in chemistry,
biology, mathematics, or engineering. Some companies,
however, require science technicians to hold a bachelor’s degree
in a biological or chemical science. In many firms, newly hired
workers begin as laboratory helpers or aides, performing routine
jobs such as cleaning and arranging bottles, test tubes, and
other equipment.
The experience required for higher level technician jobs varies
from company to company. Usually, employees advance
over a number of years from assistant technician, to technician,
to senior technician, and then to technical associate, or supervisory
technician.
For most scientific and engineering jobs, a bachelor of science
degree is the minimum requirement. Scientists involved in
research and development usually have a master’s or doctoral
degree. A doctoral degree is generally the minimum requirement
for medical scientists, and those who administer drug or gene
therapy to patients in clinical trials must have a medical degree.
Because biotechnology is not one discipline, but the interaction
of several disciplines, the best preparation for work in biotechnology
is training in a traditional biological science, such as
genetics, molecular biology, biochemistry, virology, or biochemical
engineering. Individuals with a scientific background and
several years of industrial experience may eventually advance to
managerial positions. Some companies offer training programs
to help scientists and engineers keep abreast of new developments
in their fields and to develop administrative skills. These
programs may include meetings and seminars with consultants
from various fields. Many companies encourage scientists and
engineers to further their education; some companies provide
financial assistance or full reimbursement of expenses for this
purpose. Publication of scientific papers also is encouraged.
Pharmaceutical manufacturing companies prefer to hire college
graduates, particularly those with strong scientific backgrounds.
In addition to a 4-year degree, most newly employed
pharmaceutical sales representatives complete rigorous formal
training programs revolving around their company’s product lines.
Outlook
The number of wage and salary jobs in pharmaceutical and medicine
manufacturing is expected to increase by about 26 percent
over the 2004-14 period, compared with 14 percent for all industries
combined. Pharmaceutical and medicine manufacturing
ranks among the fastest growing manufacturing industries. Demand
for this industry’s products is expected to remain strong.
Even during fluctuating economic conditions, there will be a
market for over-the-counter and prescription drugs, including
the diagnostics used in hospitals, laboratories, and homes; the
vaccines used routinely on infants and children; analgesics and
other symptom-easing drugs; antibiotics and other drugs for
life-threatening diseases; and “lifestyle” drugs for the treatment
of nonlife-threatening conditions.
Although the use of drugs, particularly antibiotics and vaccines,
has helped to eradicate or limit a number of deadly diseases,
many others, such as cancer, Alzheimer’s, and heart disease,
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continue to elude cures. Ongoing research and the manufacture
of new products to combat these diseases will continue to contribute
to employment growth.
Because so many of the pharmaceutical and medicine manufacturing
industry’s products are related to preventive or routine
healthcare, rather than just illness, demand is expected to
increase as the population expands. The growing number of
older people who will require more healthcare services will further
stimulate demand—along with the growth of both public
and private health insurance programs, which increasingly cover
the cost of drugs and medicines.
Another factor propelling demand is the increasing popularity
of “lifestyle” drugs that treat symptoms of chronic nonlifethreatening
conditions resulting from aging or genetic predisposition,
and can enhance one’s self-confidence or physical appearance.
Other factors expected to increase the demand for
drugs include greater personal income and the rising health consciousness
and expectations of the general public.
Despite the increasing demand for drugs, drug producers
and buyers are expected to place more emphasis on cost effectiveness,
due to concerns about the cost of healthcare, including
prescription drugs. Growing competition from the producers
of generic drugs also may exert cost pressures on many firms in
this industry, particularly as brand-name drug patents expire. In
addition, the average time for the FDA to review “nonpriority”
drug applications is becoming longer, further delaying the time a
drug comes to market. These factors, combined with continuing
improvements in manufacturing processes, are expected to result
in slower employment growth over the 2004-14 period than
occurred during the previous 10-year period.
Strong demand is anticipated for professional occupations—
especially for life and physical scientists engaged in R&D, the
backbone of the pharmaceutical and medicine manufacturing
industry. Much of the basic biological research done in recent
years has resulted in new knowledge, including the successful
identification of genes. Life and physical scientists will be needed
to take this knowledge to the next stage, which is to understand
how certain genes function so that gene therapies can be
developed to treat diseases. Computer specialists such as systems
analysts, biostatisticians, and computer support specialists
also will be in demand as disciplines such as biology, chemistry,
and electronics continue to converge and become more
interdisciplinary, creating demand in rapidly emerging fields such
as bioinformatics and nanotechnology. Strong demand also is
projected for production occupations. Employment of office
and administrative support workers is expected to grow more
slowly than the industry as a whole, as companies streamline
operations and increasingly rely on computers. In an effort to
curb research and technological development costs, many companies
have merged. As companies consolidate and grow in
size, so do their marketing and sales departments. Despite substantial
increases over the past decade, sales forces at pharmaceutical
and medicine manufacturing firms should continue to
experience strong growth as companies promote and sell their
products to doctors at hospitals and private clinics.
Unlike many other manufacturing industries, the pharmaceutical
and medicine manufacturing industry is not highly sensitive
to changes in economic conditions. Even during periods
of high unemployment, work is likely to be relatively stable in
this industry.
Earnings
Earnings of workers in the pharmaceutical and medicine manufacturing
industry are higher than the average for all manufacturing
industries. In May 2004, production or nonsupervisory
workers in this industry averaged $892 a week, while those in all
manufacturing industries averaged $659 a week. Earnings in
selected occupations in pharmaceutical and medicine manufacturing
appear in table 2.
Some employees work in plants that operate around the
clock—three shifts a day, 7 days a week. In most plants, workers
receive extra pay when assigned to the second or third shift.
Because drug production is subject to little seasonal variation,
work is steady.
Sources of Additional Information
For additional information about careers in pharmaceutical and
medicine manufacturing and the industry in general, write to the
personnel departments of individual pharmaceutical and medicine
manufacturing companies.
For information about careers in biotechnology, contact:
􀂾 Biotechnology Industry Organization, 1625 K St. NW., Suite
1100, Washington, DC 20006. Internet: http://www.bio.org
For information on careers in pharmaceutical and medicine
manufacturing, contact:
􀂾 Pharmaceutical Research and Manufacturers of America
(PHRMA), 1100 15th St. NW., Washington, DC 20005. Internet:
http://www.phrma.org
Information on these key pharmaceutical and medicine manufacturing
occupations may be found in the 2006-07 edition of
the Occupational Outlook Handbook.
• Assemblers and fabricators
• Biological scientists
• Computer scientists and database administrators
• Computer support specialists and systems administrators
• Computer systems analysts
• Chemists and material scientists
• Engineers
• Inspectors, testers, sorters, samplers, and weighers
• Medical scientists
• Sales representatives, wholesale and manufacturing
• Science technicians