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Manager, Industrial Production (Drug Manufacturing)


Summary
ActivitiesPlan, direct, or coordinate the work activities and resources necessary for manufacturing medicinal and other health-related products in accordance with cost, quality, and quantity specifications.

OutlookSlower-than-average job growth

Median Income$83,300 per year in 2008

Work Context & ConditionsMost industrial production managers divide their time between production areas and their offices.

Minimum Education RequirementsBachelor's Degree

SkillsMonitoring, Management of Personnel Resources, Critical Thinking, Instructing, Time Management, Complex Problem Solving, Judgment and Decision Making, Coordination, Reading Comprehension, Speaking

AbilitiesOral Expression, Deductive Reasoning, Problem Sensitivity, Written Comprehension, Inductive Reasoning, Oral Comprehension




Job Description
Job CategoryManagement

Job DescriptionThe drug 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, and cancer. For example, anti-nausea 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 increased animal productivity and controlled various diseases, some of which are transmissible to humans.

At each stage of life -- from early infancy through old age -- innovative drug discoveries help millions of patients lead longer, healthier, happier, and more productive lives. These longer life spans are due, in large part, to the conquest of diseases by drug research and manufacturing. But modern drugs do even more than save lives and improve the well-being of patients. As they improve health, they also save money by keeping people out of hospitals, emergency rooms, and nursing homes.

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 -- is just beginning. Thousands of new drugs are expected to be developed in the coming years.

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 drug industry consists of more than 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. Pharmaceutical manufacturing firms make up the majority of establishments and employ almost 80 percent of the workers in this industry.

The U.S. drug industry has achieved worldwide prominence through research and development (R&D) of new drugs, and spends a relatively high proportion of its funds on R&D compared with other industries. Each year, drug industry testing involves many thousands of new substances, yet may eventually yield only 10 to 20 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 drug manufacturing firms start this process by seeking new chemical compounds with the potential to prevent, combat, or alleviate symptoms of diseases or other health problems. Scientists use sophisticated tools, such as computer simulation and combinatorial chemistry, 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 in 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 high-cost process -- only one in every 5,000 to 10,000 compounds screened eventually becomes an approved drug.

After laboratory screening, firms conduct clinical investigations, 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.

After a drug successfully passes animal and clinical tests, the U.S. Food and Drug Administration (FDA) 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 many years. However, scientific and information technology advances will shorten that process considerably for most drugs. Furthermore, the FDA is becoming more efficient in reviewing and approving drugs.

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 marketing the drug, 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, drug 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, primarily work in marketing, they engage in quality control when they assist pharmacists in checking for outdated products.

Industrial production managers involved in drug manufacturing direct and coordinate production, processing, distribution, and marketing activities for medicinal and other health-related productions.

Managers are responsible for the review of processing schedules and production orders to determine staffing requirements, work procedures, and duty assignments. They review plans and confer with research and support staff to develop new products and processes or to improve the quality of existing products.

Some production managers also initiate and coordinate inventory and cost control programs and may negotiate materials prices with suppliers. They are required to develop budget and approve expenditures for supplies, materials, and human resources.

Other responsibilities include: coordinating and recommending procedures for facility and equipment maintenance or modification, examining samples of raw products or directs testing during processing to ensure finished products conform to prescribed quality standards, and preparing and maintaining production reports and personnel records.

Working ConditionsWorking 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 2002, the incidence of work-related injury and illness was 3.0 cases per 100 full-time workers, compared with 7.2 per 100 for all manufacturing industries and 5.3 per 100 for the entire private sector.

Only about 5 percent of the workers in the pharmaceutical and medicine manufacturing industry are union members or are covered by a union contract, compared with about 15 percent of workers throughout private industry.

Salary RangeMedian annual earnings for industrial production managers were $83,300 in 2008. The middle 50 percent earned between $64,400 and $108,700. The lowest 10 percent earned less than $50,300, and the highest 10 percent earned more than $140,500.

Earnings of workers in the pharmaceutical and medicine manufacturing industry are higher than the average for all manufacturing industries.



Education
Education RequiredFor 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 for this purpose. Publication of scientific papers also is encouraged.

Drug manufacturing companies prefer to hire college graduates, particularly those with strong scientific backgrounds, as pharmaceutical detailers. Newly employed pharmaceutical representatives complete rigorous formal training programs revolving around their company’s product lines.

Recommended High School CoursesComputers and Electronics, Biology, Mathematics, Chemistry, Physics

Postsecondary Instructional ProgramsAdministration and Management, Production and Processing, Chemistry, Biology, Medicine and Dentistry

Certification and Licensing



Skills, Abilities, & Interests
Interest Area
EnterprisingInvolves starting up and carrying out projects, leading people, making many decisions, and dealing with businesses, and it sometimes requires risk taking.

Work Values
Company Policies and PracticesTreated fairly by the company.
CreativityTry out your own ideas.
ActivityBusy all the time.
AutonomyPlan work with little supervision.
AuthorityGive directions and instructions to others.
CompensationGet paid well in comparison with other workers.
ResponsibilityMake decisions on your own.

Skills
MonitoringAssess how well someone is doing when learning or doing something.
Management of Personnel ResourcesMotivate, developing, and directing people as they work, identifying the best people for the job
Critical ThinkingUse logic and analysis to identify the strengths and weaknesses of different approaches.
InstructingTeach others how to do something.
Time ManagementManage one's own time and the time of others.
Complex Problem SolvingSolving novel, ill-defined problems in complex, real-world settings.
Judgment and Decision MakingBe able to weigh the relative costs and benefits of a potential action.
CoordinationAdjust actions in relation to others' actions.
Reading ComprehensionUnderstand written sentences and paragraphs in work-related documents.
SpeakingTalk to others to effectively convey information.

Abilities
Oral ExpressionAble to convey information and ideas through speech in ways that others will understand.
Deductive ReasoningAble to apply general rules to specific problems to come up with logical answers, including deciding whether an answer makes sense.
Problem SensitivityAble to tell when something is wrong or likely to go wrong. This doesn't involve solving the problem, just recognizing that there is a problem.
Written ComprehensionAble to read and understand information and ideas presented in writing.
Inductive ReasoningAble to combine separate pieces of information, or specific answers to problems, to form general rules or conclusions. This includes coming up with a logical explanation for why seemingly unrelated events occur together.
Oral ComprehensionAble to listen to and understand information and ideas presented through spoken words and sentences.



More Information
Related JobsBiomedical Engineer, Engineer, Industrial Safety and Health

Job OutlookPharmaceutical and medicine manufacturing provided 289,000 wage and salary jobs in 2008. Pharmaceutical and medicine manufacturing establishments typically employ many workers. About 87 percent of this industry’s jobs in 2008 were in establishments that employed 100 or more workers. Most jobs are in California, Illinois, Indiana, New Jersey, New York, North Carolina, and Pennsylvania.

About 31 percent of all jobs in the pharmaceutical and medicine manufacturing industry are in professional and related occupations, mostly scientists and science technicians. About 27 percent of jobs are in production occupations, including both low skilled and high skilled jobs. The remaining jobs are primarily management, and office and administrative support occupations.

The number of wage and salary jobs in pharmaceutical and medicine manufacturing is expected to increase by about 6 percent over the 2008-18 period, compared with 11 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; and antibiotics and “miracle” drugs for life-threatening diseases.

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, 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 non-life-threatening conditions resulting from aging, and can enhance one’s self-confidence or physical appearance. Other factors expected to increase the demand for drugs include greater personal income, the rising health consciousness and expectations of the general public, and a more industry-friendly regulatory environment that has streamlined the FDA approval process for “priority” drugs—those the FDA concludes are potentially life-saving treatments.
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. Furthermore, innovative drug development measured by the number of industry applications submitted to the FDA has slowed dramatically, and the average time for the FDA to review “nonpriority” drug applications is becoming longer. 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. These factors, combined with continuing improvements in manufacturing processes, are expected to result in slower employment growth over the 2008-18 period than occurred during the previous 10-year period. Strong demand is projected for production occupations.

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.

More InformationAmerican Management Association, Biotechnology Industry Organization (BIO), Pharmaceutical Research and Manufacturers of America (PHRMA)

ReferencesBureau of Labor Statistics, U.S. Department of Labor, Career Guide to Industries, 2010-11 Edition, Pharmaceutical and Medicine Manufacturing, on the Internet at http://www.bls.gov/oco/cg/cgs009.htm

Bureau of Labor Statistics, U.S. Department of Labor, Occupational Outlook Handbook, 2010-11 Edition, Industrial Production Managers, on the Internet at http://www.bls.gov/oco/ocos016.htm

O*NET OnLine, on the Internet at
http://online.onetcenter.org/link/summary/11-3051.00