The first step is to actually develop a product. This process takes years. And for every medicine that ends up being used by patients, there are thousands more that never make it through this process.

Much of this R&D process takes place in laboratories, before moving on to clinical trials.

Drug companies each have their own “pipeline” of products – the ones currently in development that they expect to start producing over the coming years (depending on the outcome of trials and regulatory applications).

It is becoming increasingly common for pharmaceutical companies to leave earlier stages of research to specialist companies, and to buy the rights to promising products once they’re further along in the development process.

The final stages of this process are gaining regulatory approval for a product. To do this, pharmaceutical companies must compile the evidence from clinical trials and show that the product has a benefit to patients. They will need different regulatory approval to sell their product in different geographical areas (for example, FDA approval to market a product in the United States).

We’re going to take a closer look at 4 specific areas of research and development (R&D) and drug safety:

• Lab-based R&D
• Clinical Trials
• Regulatory Affairs
• Pharmacovigilance (drug safety)

Typically working in labs to identify new molecules that could be used in medications, how known molecules can be “packaged” into medicines, or on improving currently available medications.

Examples of jobs in this category include:

1) Senior Scientist (with development to senior/principle)
– scientists are involved in every product’s research and development phase. The specific type of scientist, the necessary skills, and the duties of the role will depend on the type of product in development.

2) Product Development Scientist
– works to create an efficient and successful path to a product’s creation. Some of their job responsibilities include planning and organizing production trials, recording and analyzing data and consulting with engineers and other scientists on staff.

3) Biochemist
– scientific professionals who study and explore the chemical processes with biological organisms. Within the pharmaceutical industry, biochemists are employed within research and development departments as well as within quality teams in manufacturing departments.

4) Microbiologist
– a scientific professional who studies microorganisms. They play a key role in pharmaceutical or medical device manufacturing by testing to monitor levels of microbial contamination at all stages of the manufacturing process.

5) Laboratory Technician
– assist industry scientists in their research and testing. This can involve a number of different tasks and these tasks can vary greatly between roles. Within the pharmaceutical industry, laboratory technicians can be employed in research and development or in production and manufacturing. As a result, the work can be based in a laboratory or on a production line, depending on the specific responsibilities of the role.

Salary information:

Click here for salary information for science roles.

We are not specialists in this part of the industry and cannot offer any career advice beyond basic job-hunting skills.

Clinical trials are research studies performed on a drug to establish or check its safety and effectiveness.

Before a medical product can be prescribed by doctors or sold to patients, it needs to be approved by regulatory bodies (such as the FDA, EMA or PMDA). These bodies give approval based on the outcomes of clinical trials – a company needs to show that their product is safe to be used, and has the desired effect.

Early clinical trials are done in labs, then with a small number of people (to test safety), then with a larger number of patients who have the condition the product aims to treat (to test effectiveness).

Examples of jobs in this category include:

1) Clinical Trial Administrator (CTA)
– provides administrative support to clinical trial sites and clinical research associates.

2) Clinical Research Associate (CRA)
– coordinates the running of clinical trials. This can involve a variety of tasks including writing trial protocols, training of staff at trial sites, collection of trial data and writing reports documenting trial outcomes.

3) Epidemiologist
– an epidemiologist focuses on the study of who gets sick and why. They also figure out how outbreaks affect certain communities and try to find solutions to prevent them in the future.

4) Healthcare Professionals
– (including doctors, nurses, and pharmacists) can also often find roles here depending on the trial and the level of healthcare oversight needed.

We are not specialists in this part of the industry and cannot offer any career advice beyond basic job-hunting skills.

This department makes sure that a pharmaceutical company and its products meet government regulations and deals with the applications and ongoing paperwork before/when a medicine is sold to the public.

Examples of jobs in this category include:

1) Regulatory Affairs Specialist / Officer / Associate – involved in ongoing quality monitoring across the company. Gather and collate the data and information needed for review and submission to regulatory agencies.

2) Qualified Person – is a technical term used in European Union pharmaceutical regulation. QPs are legally responsible for certifying batches of medicinal products before they’re used in clinical trials or available on the market.

We are not specialists in this part of the industry and cannot offer any career advice beyond basic job-hunting skills.

This role deals with monitoring and reporting the effectiveness and any side effects of pharmaceutical products.

Examples of jobs in this category include:

1) Pharmacovigilance Officer – also called a drug safety officer. They are responsible for monitoring and reporting the effectiveness and any adverse effects or side effects of pharmaceutical products on the market in the general population and in hospitals and research trials.

We are not specialists in this part of the industry and cannot offer any career advice beyond basic job-hunting skills.

Once a product has regulatory approval, it can be prescribed by doctors and/or sold to patients, so the company begins the manufacturing process.

Manufacturing of medicines is a bit like manufacturing any other product, but there are some important differences.

Most notably, the rules and regulations that surround pharmaceutical manufacturing are specific for this industry, and they’re strict.

Of course, this makes sense when you consider that what’s being manufactured will be consumed by patients and is intended to help treat an illness or disease. It’s extremely important that every batch of medicine meets the same standards. There can never be a “not so good” batch of medicine.

These strict regulations mean that companies have very particular requirements about staff training, process documentation, and adhering to protocols during all parts of the manufacturing process. Not only that, regulatory authorities can (and will) audit a company’s compliance with these regulations.

A company found to not meet these industry standards can be fined and even made to halt production until regulations are shown to be met.

Companies take these regulations extremely seriously – each and every staff member has to as well.

There are several departments within the “manufacturing” stage, including:

• Production
• Engineering
• Science
• Quailty Assurance
• Quality Control
• Validation
• Operations

The team of people who operate the machinery and systems that actually produce the pharmaceutical product. In a typical manufacturing plant, this is approximately 50% of total staff and consists of both engineering and manufacturing/production/operator staff.

These jobs suit:

• People with previous manufacturing experience from any industry
• Entry-level manufacturing jobs can also be a good entry point for people changing career with no previous manufacturing experience

Examples of jobs in this category include:

1) Process Technician
– operates equipment, monitors processes and documents results in strict adherence to protocols. They are involved in all stages of the manufacturing process and in the pharmaceutical and medical device industries, their role often occurs within a clean-room environment.
Some companies might call this role:

• Chemical Process Technician
• BioProcess Technician

2) Cleanroom Operator
–  operates equipment, follows processes and procedures in strict adherence to protocols. As the name suggests, the role often requires people to work in a clean-room environment. This is an entry-level position with many of the tasks and duties overlapping with that of a process technician but requires less technical knowledge.

3) Manufacturing Technician
– work in a discrete manufacturing environment. Run and maintain factory equipment and assembly processes, monitor and check the product quality, and document results in strict adherence to protocols.
Some companies might call this role:

• Production Technician
• Manufacturing Operator
• Production Operator
• Assembler

4) Packaging Operator
– responsible for taking the finished product of a manufacturing process and ensuring that it is packaged in line with company and industry standards, making it ready for sale or distribution.
Some companies might call this role:

• Packaging Technician

5) Production Supervisor
– directly responsible for overseeing and organizing the equipment, staff, and processes on a production floor. They will oversee scheduling and routine production activities as well as acting as first-line troubleshooting should problems arise.
Some companies might call this role:

• Process Supervisor
• Manufacturing Supervisor

Salary Information:

Click here for salary information for manufacturing/production roles.

How you’d change your career to a manufacturing job in pharma:

• If you don’t have previous experience in a GMP environment (and if you’re not sure what it is, you probably don’t have it), you should start with the 16-week Conversion Course into Pharma Manufacturing
• If you have GMP experience and are looking to move into more senior roles, get your knowledge accredited with our University Certificate in eBioPharmaChem

These jobs suit:

• Candidates with a process, chemical, production, manufacturing, industrial or other relevant engineering qualification

Examples of jobs in this category include:

1) Process Engineer
– (also known as a chemical engineer) is responsible for designing, implementing, controlling and optimizing industrial processes, especially continuous ones within the chemical, petrochemical, agriculture, mineral processing, advanced material, food, pharmaceutical, and biotechnological industries.

2) Manufacturing Engineer
– responsible for the development, design, implementation, and monitoring of equipment, tools, and machinery used in the manufacturing process. Their primary goal is to create the stages of a manufacturing system that ultimately produces a product in the most time-efficient and cost-effective way possible, while always maintaining staff safety and product quality.

3) Mechanical Engineer
– responsible for designing, developing, building, and testing all sorts of mechanical devices, tools, engines and machines. Mechanical Engineers are more likely to work in medical device manufacturing.

Salary information:

Click here for salary information for engineering roles.

How you’d change your career to an engineering job in pharma:

Mechanical or Manufacturing Engineers

• Even with an engineering qualification and engineering work experience, you’ll still need to understand the specific rules and regulations of pharma manufacturing. Check out the 18-week Conversion Course into Engineering Roles in Pharma for more details.

Process Engineers and Chemical Engineers

You generally don’t need any additional training but you could certainly benefit from taking a course on Good Manufacturing Practices (GMPs) if you have no experience working in a GMP manufacturing environment or have not covered them in your undergraduate p