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 program.

Another option would be to take our equipment validation training course and retrain for validation roles as your background in engineering design and interpreting P&ID technical drawings are highly relevant to this field.

These jobs suit:

• Candidates with biochemistry, biotechnology, cell biology, chemistry, immunology, microbiology, biological science, and chemical science background.

Science Roles (that support manufacturing)

Typical roles support the manufacturing process in a regulated environment and work within multidisciplinary teams to produce medicinal products.

Examples of jobs in this category include:

1) Microbiology/Particle Analyst

2) Process Sciences Manager-Upstream

3) Environmental Microbiologist

4) Bioprocessing Scientist

5) Production Scientist

6) Senior Scientist Technical Support

7) Process Scientist / Specialist – Purification

Science Roles (that support development)

This is the “D” part of “R&D”. Development is the phase after research where the creation of a proven drug is moved from the lab to the manufacturing plant.

Examples of jobs in this category include:

1) Tech Transfer Scientist Jobs

2) Process Technology Transfer Scientist

3) Transfer Scientist

4) Product and Process development scientists

Salary information:

Click here for salary information for science roles.

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

• Even with a science qualification and work experience, you’ll still need to understand the specific rules and regulations of pharma manufacturing. Check out the 15-week Conversion Course into Science Roles in Pharma for more details.

Quality Assurance (QA) is process-oriented and focuses on removing any variation from the processes of manufacturing. This is achieved by creating, revising, and strictly implementing a set of precisely defined procedures and quality standards that, when followed exactly, ensure the final quality of the product.

Quality Assurance is preventative by nature and makes sure things are done “right first time”.

These jobs suit:

• Candidates with experience in similar quality roles in other industries
• Candidates with previous pharmaceutical manufacturing experience, looking to specialize

Examples of jobs in this category include:

1) Quality Assurance Specialist
– monitors and records results from processes and procedures within manufacturing industries. Results are continually compared to predetermined expected ranges and any deviation from expected results leads to corrective measures. Some companies might call this role:

• QA Associate
• Quality Assurance (QA) Technician
• QA Specialist

2) Quality Engineer
– works within the quality team to ensure the overall quality of a manufactured product and are tasked with creating documentation, devising quality tests and defining the criteria a test result should meet. They play a key role in fixing issues when they arise. Some companies might call this role:

• QA Engineer
• QC Engineer

3) Documentation Specialist
– the individual responsible for the writing, distribution, collection, storage, and maintenance of a company’s documentation. In highly regulated industries, these activities are a requirement for regulatory compliance. Some companies might call this role:

• Document Controller
• Documentation Coordinator

Salary information:

Click here for salary information for quality roles.

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

• If you have experience in quality from a different industry, you’ll still need to get to grips with the specific rules and regulations of pharma manufacturing, check out the 15-week Conversion Course into Quality Roles in Pharma
• Those with pharma industry experience looking to specialize or move into more senior roles should consider the university accredited Level 7 Certificate in eBioPharmaChem

Quality Control (QC) is product-oriented and focuses on testing samples from the manufacturing process to make sure they meet the required specifications and standards.

In pharmaceutical manufacturing, the sample testing is done in a laboratory so people who work in QC usually have a science/laboratory background.

These jobs suit:

• Candidates with experience in similar quality roles in other industries
• Candidates with laboratory science qualifications/experience

Examples of jobs in this category include:

1) Quality Control Analyst
– tests the product of a manufacturing process to ensure that it meets predefined criteria. The completion of this quality check ensures that the final product is safe to release for sale or distribution. Some companies might call this role:

• QC Associate
• Quality Control (QC) Technician
• QC Specialist

Salary information:

Click here for salary information for quality roles.

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

• If you have a lab science background and want to get into QC roles, check out the 15-week Conversion Course into Quality Roles in Pharma.

The department that assesses and documents all equipment and processes to ensure that an action, process, or system leads to a consistent and reproducible result. (Check out this article for a much more detailed look at pharmaceutical validation, IQ OQ PQ and equipment validation protocols).

These jobs suit:

• Candidates with previous pharmaceutical manufacturing experience, looking to specialize
• People with previous work experience that requires them to read and interpret technical drawings (e.g. Pipe-fitters, Plumbers, Pipe Welders, Piping Supervisors, Boiler Technicians, and Electricians)
• Those with commissioning and qualification experience from any industry

Examples of jobs in this category include:

1) Validation Technician
– works as part of the Validation team to measure and analyze the manufacturing process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result. This ensures that the product is consistently of the highest quality. Some pharma companies might call this role:

• Associate QA Validation Specialist
• Equipment & Process Validation Specialist
• QA Validation Associate
• QA Validation Specialist

2) CQV Engineer
– A CQV Engineer makes sure that all systems, facilities and equipment are installed properly and meet the design requirements put in place for the end-users in a pharmaceutical facility. They document the process of installation, operation and how it performs. CQV is focused on the performance of equipment.
Also, some pharma companies might call this role:

• CQV Specialist
• C&Q Engineer
• Validation Specialist

3) Validation Engineer
– responsible for planning, implementing and monitoring the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing. They measure and analyze the process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result to ensure the highest quality products are produced.

4) Cleaning Validation Engineer
– Design and develop cleaning procedures for new products and manufacturing equipment and also investigate and conduct troubleshooting/root cause analysis of cleaning related incidents, and deviations for non-validated or underdeveloped cleaning procedures. This is a highly specialised role requiring in-depth knowledge of chemical cleaning processes so most practitioners tend to have a lab/science, chemistry or chemical/process engineering background or have learnt experientially on the job through extensive work experience or on-the-job training. Some companies might call this role:

• Cleaning Validation Specialist
• QA Validation Specialist – Cleaning Validation

5) Process Validation Engineer
– This is generally considered an advanced role and requires thorough process knowledge and experience with process validation engineers working in engineering design, tech transfer, upstream and downstream manufacturing. Most practitioners tend to have a lab/science, chemistry or chemical/process engineering background or have learnt experientially on the job through extensive work experience.

6) Computer System Validation (CSV) Engineer
– plan, write, implement and review the Computer Systems Validation or CSV protocols in place within highly regulated manufacturing industries. Their work is essential to make sure that all computer-based systems are operating as intended (with documents to prove it) to meet regulatory requirements.

Salary information:

Click here for salary information for validation roles.
Click here for salary information for CSV roles.

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

• To get started in validation you’ll need to take the Equipment Validation Training Course – For Starter Validation, CQV or C&Q Roles. If you have GMP experience, you’ll be exempt from the first 5-weeks of the program (and get a price reduction)
• For those already in junior validation roles looking to progress, check out our university accredited Pharmaceutical Validation Engineer Training Course – For Senior Validation and CQV Roles
• If you’re looking to extend your validation skillset to include Computer System Validation (CSV), check out the online Computer Systems Validation Training Course

The group of people that ensures the continuous functioning of a manufacturing plant and its equipment. People in this department often come from a wide range of backgrounds, bringing specific skill sets with them.

These jobs suit:

• Candidates with similar (maintenance) work experience from a different industry
• Candidates with mechanical, automation or project engineering qualification and work experience from a different industry
• Individuals with an appropriate and related qualification

Examples of jobs in this category include:

1) Maintenance Technician
– tasked with routine maintenance of manufacturing equipment as well as helping to troubleshoot when issues arise. Due to the regulation of the pharmaceutical and medical device industries, they are required to keep detailed and accurate documentation of their work. Some companies might call this role:

• Maintenance Engineer

2) Instrumentation Engineer
– provision of computer programming and instrumentation support as well as designing and developing specialised instrumentation and equipment as required.

3) Calibration Technician
– responsible for the routine inspection, testing, maintenance and repair of instruments and manufacturing equipment. The purpose of the calibration technician’s role is to ensure the accuracy of the measurements taken using this equipment. Some companies might call this role:

• Electrical and Instrumentation Technician

4) Facilities Engineer
– can have an extremely broad remit covering the infrastructure of the building, depending on the needs of the company. Areas of direct responsibility might include environmental, health, and safety issues, electrical engineering or HVAC (heating, ventilation and air conditioning).

5) Automation Engineer
– utilizes technology to improve, streamline and automate a manufacturing process. They are responsible for planning, implementation, and monitoring of such technology.

6) Project Engineer
– manages technical or engineering projects. They work with stakeholders at all levels, with direct responsibility for budgeting, personnel and project planning.

Salary information:

Click here for salary information for maintenance roles
Click here for salary information for automation roles

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

Maintenance Technician

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

Calibration Engineer, Instrumentation Engineer

• If you already are working as a calibration engineer and wish to retrain to work in the same job within the pharmaceutical or medical device manufacturing industry, check out out GMP Training for Beginners program.

Facilities Engineer

• If you already work as a facilities engineer and would like to retrain to perform the same or similar role within the pharmaceutical industry, check out our 18-week Conversion Course into Engineering Roles in Pharma.

Automation Engineer

• If you want to move into roles in the pharmaceutical or medical device industry that include managing or upgrading GxP computerized system application, check our Computer System Validation Course and learn how to manage electronic data in a regulated manufacturing/laboratory/clinical environment in compliance with FDA’s 21 CFR Part 11 or other regulatory guidelines using the GAMP framework.

Successfully manufacturing a product that meets quality standards and regulatory approval is only two-thirds of the journey. 

Once a product is manufactured, it then has to be distributed for sale. And potential customers have to be made aware of its existence.