Pharmaceuticals and Biotechnology

Pharma/biotech workers help create, produce, and sell therapeutics, diagnostics, and over-the-counter drugs and vitamins. Typical pharma/biotech companies offer career paths in a variety of departments.

Research and Development

The pharma/biotech industry is a research-intensive field. In fact, research and development (R&D) is the heart of the industry. According to the Pharmaceutical Research and Manufacturers of America, biopharmaceutical companies “invests on average six times more in R&D as a percentage of sales than all other manufacturing industries.” R&D is where workers develop and discover promising new drug candidates. The three major functions of the R&D department are molecular research, in vitro and in vivo pharmacology, and bioinformatics. Workers in molecular research perform experiments that identify potential drug candidates and vulnerabilities for drugs to target on a type of cell. Pharmacologists create cell cultures, grow microorganisms, and manage the care of animals used in discovery research. Collecting, managing, and analyzing all the data developed during research are bioinformatics specialists, who assist molecular and cell biologists and in vivo pharmacologists in identifying the most promising compounds.

Clinical Research

Drug candidates developed by R&D take the next step toward widespread use by patients in the clinical research department. This department oversees the drug through the U.S. Food and Drug Administration and other government regulators’ approval process, essential to making a drug available to the public. Clinical research staff run clinical trials to determine a drug’s safety and effectiveness, or “efficacy.”

Regulatory Affairs

The regulatory affairs department makes sure all the “t’s are crossed and all the “i’s” are dotted when a drug is approved. They are the liaison with the Food and Drug Administration and other local health authorities (prescription drugs) and Federal Trade Commission (over-the-counter drugs) during the drug application process. It’s up to them to complete all reporting requirements in a timely manner. At companies with international operations, regulatory affairs workers may also interact with other regulatory agencies such as the European Medicines Agency, Health Canada, and The International Conference for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Employees in this department prepare, publish, and archive technical documentation; communicate with FDA and other health authorities during product development; craft responses to FDA queries about a drug; coordinate with the FDA to finalize drug label and marketing information; and work with the business development department to address regulatory hurdles so that new products can be developed.

Manufacturing and Supply Chain

Manufacturing department workers make drugs for clinical or commercial use. Once R&D identifies a promising drug candidate, process/product development workers begin the clinical manufacturing process. First, they determine how to “scale up” from tiny, laboratory-size samples enough of a product for clinical trials. When a drug emerges from clinical trials successfully, then manufacturing and production workers create the final product—complete with packaging and labeling—and then the public sees it on drugstore shelves. Coordinating closely with the manufacturing department, supply chain workers ensure that all the ingredients and supplies necessary to produce finished drugs are available. They also streamline the drug shipping process and make sure drugs reach their destination on time and without damage. Environmental health and safety professionals also work in the manufacturing department to assess the environmental impact of the ingredients of a product and the production process that will be used to manufacture it.

Quality

The quality department is essential to producing safe, effective drugs. It ensures that all products are manufactured to rigorous, consistent standards. Different groups in this department focus on quality control, quality assurance, and quality systems. Well-defined and documented procedures must be followed when producing a drug either for clinical trials or consumers, and every last detail counts. Subgroups in the quality-control group concentrate on chemistry labs, microbiology labs, cell biology labs, animal labs, environmental monitoring, and metrology. The quality-assurance group has three main functions: documentation review; auditing products, procedures, and systems; and compliance with the Prescription Drug Marketing Act. The quality-systems group also includes subgroups such as validation, information technology quality, training, document management, corrective and preventive action, and quality engineering.

Finance and Administration

Discovering new drugs and helping people may be the heart of pharma/biotech, but it’s the business side of things that enables that work to be done. Finance and administrative workers manage the company’s finances as well as its legal relationships with investors, creditors, and employees. At some companies, information systems and legal workers may also belong to this department.

Information Systems and Technology

Powerful data tools and technology are essential for drug research. Computers (including those with learning abilities, such as IBM Watson), databases, data analytics software, artificial intelligence, blockchain technology, and other technology play a major role in any pharma/biotech company. Information technology workers manage company-wide intranets, provide user support to employees, troubleshoot and repair faulty equipment, install new hardware and software, design proprietary computer systems and software, and, perhaps most importantly, secure company systems and sensitive data against hackers and industrial espionage.

Legal Affairs

The legal department provides legal advice to other departments. It is also the keeper of the flame when it comes to managing the company’s intellectual property, which includes patents, copyrights, trademarks, and trade secrets. The United States leads the world in biopharmaceutical intellectual property development, according to a Pharmaceutical Research and Manufacturers of America analysis of National Science Foundation data. In 2016, 56.9 percent of pharmaceutical patents were awarded to companies in the United States. The department also facilitates business transactions (including mergers and acquisitions), incorporates companies, and advises on private venture equity financings or IPOs, regulatory issues, transactional law, and employment law.

Business Development

Business development professionals identify prospective new partners and manage existing alliances. A business development professional at a small drug company that’s expanding its cancer-fighting biotech product line, for instance, would study biotech start-ups to identify those that have drugs or technology that might make it a good candidate for collaboration. The department then collects pertinent information about the candidate company, its products, and its technology and prepares a report for executives for further review.

Marketing and Sales

Marketing is a key aspect of the pharma/biotech industry. In fact, the industry spent approximately $6.88 billion in 2021 on direct-to-consumer ads, according to Statista.com, up from $4.3 billion in 2013. Once a drug is approved it is presented to the public. Marketing workers identify target customer bases, set pricing and promotion strategy, and develop marketing and publicity materials and campaigns. Sales workers develop sales strategies and campaigns and meet with potential customers—often specialist physicians (e.g., endocrinologists, cardiologists, urologists, etc.) or pharmacists—to inform them about a drug and how it can help their patients and customers.

Project Management

Coordinating all the work involved in producing a successful drug is an enormous task. That’s why many pharma/biotech companies have a separate project management department. This group ensures that work requiring the collaboration of several internal departments is done smoothly and efficiently. They also oversee special projects that don’t naturally fit into the traditional formal function of a single department but require cross-functional collaboration.

Engineering

At large pharmaceutical companies, specialized engineering departments construct and/or refurbish production plants, laboratories, office buildings, and warehouses; design and develop packaging for products; improve industrial processes; and help develop pharma/biotech products.

Commercial Strategy

Commercial strategy workers lead worldwide product lifecycle management from development candidates to patent expiration. The team coordinates with executive management, medical affairs, regional sales and marketing organizations, research and development, and corporate development to best position a product in the market. Commercial strategy projects might include identifying potential customer groups and determining the best way to market the product to them or defining how a product will be differentiated from those of competitors.

Strategic Planning

Strategic planners identify the major milestones, decisions, and investments to successfully test and launch a new drug. They also assess the commercial viability and potential of particular compounds or drug classes in the market, including analysis of how and where the company would compete with the product. Other projects include developing a product share/revenue forecast for targets.

Human Resources

Workers in the human resources department recruit, interview, and hire other workers. They also manage employee benefits and handle personnel issues, talent development, education and training, and corporate growth/expansion and relocation.

Corporate Communications

The corporate communications department creates information and publicity campaigns for the media, government agencies, investors, and company employees. Its members write press releases and other informational materials, update company Web sites and social media accounts, interface with journalists and act as their company’s spokesperson, and respond to negative news developments (e.g., corporate scandals, unexpected side effects for medications) that negatively affect the public perception’s of their employer.