1.3: The Structure of a Biotechnology Company

A typical biotechnology company will employ an array of people with credentials and experience in these disciplines. These scientists and technicians may work in a laboratory setting performing research while others may lend their expertise to other departments such as Production, Quality Control, or even Marketing. The type and number of specialized departments within a biotechnology company, as well as the way talent is distributed across them, depends on the type of company it is (agricultural, medical, environmental, and so on) and whether it is marketing a service or a product. Let’s take a closer look!

Explore!

Take the Amgen Tour! www.amgenbiotech.com/index.html

The Research and Development (R&D) Department

In these laboratories, you will find Research Scientists working alongside technicians towards a common goal: to create new products and processes and improve upon existing ones. The R&D Department is where most of the creative problem solving takes place. In some companies, Research is split off from Development. In that instance, the Research Department focuses on the discovery of new products and processes, while the Development department helps transition the discoveries from the research phase into the product production phase.

The Production Department

Once a product has been researched and developed, it becomes the responsibility of the Production Department to manufacture it. Production requirements will depend on the type of product being manufactured. At a medical biotechnology company, the Production department may resemble a large-scale laboratory if the products in production, say a bacterium, for example, are grown as cultures. In a company producing medical equipment, the production department is more likely to resemble a cleanroom with people and machinery working together to assemble the parts. Job titles in this area might be Manufacturing Operator, Technician or Supervisor, Production Technician, or Pilot Plant Operator or Technician.

The Quality (QA/QC) Department

The Quality Department establishes guidelines to monitor manufacturing processes and examining in-process and finished products to ensure adherence to quality standards. These tasks are typically split across two departments: Quality Assurance and Quality Control.

Quality Control (QC)

QC has a limited function in the company and is responsible for the testing or sampling in compliance with the specifications determined by QA. During production, the QC technicians will sample and test at many stages, including the equipment and facilities. They will be trained in appropriate techniques, such as operating equipment and performing assays, and adhering to regulations. They will be monitored and supported by QA, who hold the final responsibility for releasing the product. Thus, the QC organization has specific responsibilities that center around following the direction given by the QA organization.

Quality Assurance

QA is the function that sets up the systems and methods for “assuring” the quality of the product. The product is determined by the methods of manufacture, and QA deals with the manufacturing process to “build quality" into the product through the control, evaluation, and audit of a manufacturing system. The QA department of a manufacturing company is ultimately responsible for all the factors involved to make sure that the customer receiving the product will be satisfied.

Quality Documentation

The documentation aspect of QA is broad and varied. A well-run company has a clear paper trail for every aspect of production. Examples of quality documents include regulatory submissions, auditing records, employee training documents, quality control, and environmental testing, and product batch records.

Quality Control	Quality Assurance
monitor equipment, environment, personnel, and product test samples of the product and the materials that go into making the product to determine whether they are acceptable compare data to established standards	review all production procedures ensure that all documents are accurate, complete, and available decide whether to approve the product for release to consumers review customer complaints