Careers in Biopharmaceutical Industry
Careers in the BioPharmaceutical Industry
There are many career options for aspiring biopharmaceutical job candidates. As you might expect, you need to have the right educational background to enter this industry.
Depending on the area you intend to specialize in, the specific requirements can vary. For example, a life science degree (especially pharmacology, pharmacy, biochemistry, biology, immunology, physiology, or toxicology) or a nursing degree is one of the requirements to become a clinical research professional. A computer or IT degree will be an asset to start career as a clinical data manager. Chemistry, engineering are suitable backgrounds for Quality Assurance careers. Commerce, marketing and business management are suitable backgrounds for a marketing and management career. A licensed physician may start a career as a clinical investigator.
Even though these are the general requirements, they are not exclusive. As biopharmacetuical companies go through various stages in drug development or coporate growth, there may arise a need for specialized personell beyond the scope of clinical research. So it is common to see many tailored job advertisements requiring other educational backgrounds like health informatics, MBA, epidemiology, public health, etc.
A good way to know the kinds of jobs available and the expected qualifications is to go to the job search websites like Monster or Workopolis and search for the job area you are interested in. You will be able to see what kind of qualifications employers are looking for. In many cases just a University degree is not enough. Employers usually prefer candidates trained or experienced in supplementary industry-specific areas. For instance a Clinical Research Associate (CRA) job would require good knowledge of ICH and GCP while a Quality Assurance job would require knowledge in GMP and/or GLP and experience in writing SOP’s.
Luckily, some institutions have developed specialized training programs to allow students, new graduates or professionals seeking a career change to train in these supplementary areas (see our training page). So it is important to keep this in mind for the sake of your career preparation.
Some of the career fields available in the industry are briefly described below:
DRUG DISCOVERY AND DEVELOPMENT
Research Scientists
These are the minds behind the sceince. Normally these positions require an advanced science degree (Masters, PhD) in life sciences (biochemistry, pharmacology, medicine, immunology, genetics etc).
Bioinformatician
Professional involved in computational biology which involves the use of techniques including applied mathematics, informatics, statistics, computer science, artificial intelligence, chemistry, and biochemistry to solve biological problems usually on the molecular level. A degree in computer science or bioinformatics is required for this position.
CLINICAL DEVELOPMENT
Clinical Research Associate
CRA is a professional who monitors the administration and progress of a clinical trial (pharmaceuticals, biologics, or devices) on behalf of a sponsor company. Typical job description would include locating and briefing suitable doctors/ investigators to conduct the trial; setting up the study centers - ensuring each center has the trial materials and checking that the investigator knows exactly what has to be done; monitoring the trial throughout its duration which involves visiting the study centers on a regular basis to check the patient data in the case report forms (CRFs) and to sort out any problems which may arise; validating and collecting completed CRFs from hospitals and general practices; closing down study centers on completion of the trial; discussing results with the statistician. Writing technical reports on the trial is usually carried out by a medical statistician. A life science degree and a good knowledge of ICH and GCP is required for this position.
Clincal Data Manager
Clinical research data management, medical coding and analysis positions deal with data collected from clinical trials (pharmaceuticals, biologics, or devices) on behalf of a sponsor company. Typical work activities include: maintaining the accuracy, integrity and security of a complex, large computerized records system; applying knowledge of regulations, policies, protocols and/or procedures to control and maintain accurate records; dealing with a large volume of information which may require the need to be screened, grouped, summarized, transcribed, coded etc.; solving operational/data problems in consultation with other employees and/or supervisors; maintaining confidentiality of data as required; preparing a variety of standard status and statistical reports. General clerical/secretarial duties include data entry, collating library searches and other related tasks. Entry into this field require a degree in computer science, mathematic, statistics, or database specialist, or life and medical science. Previous data entry experience and intermediate level skills in using the following computer programs, Oracle, SAS, MS Power Point, MS Word, MS Access are an asset. A statistics or database specialist degree, degrees in computer science or other IT degrees or life science degrees (especially pharmacology, pharmacy, biochemistry, immunology, physiology or toxicology) or a nursing degree is one of the requirements for entry into clinical research data management work.
Biostatistician
This position involves the application of statistics and the life sciences in modelling real-life situation. Data derived from epidemiological studies can be analyzed this way to predict various medical and public health phenomena. In the biopharmaceutical industry, biostaticians are useful in the drug discovery process in many ways. Requirements for this position often include a degree in biostatistics, mathematics, life sciences (with some mathemetics/statistics background), computer science, epidemiology, or any related qualifications.
REGISTRATION AND REGULATORY AFFAIRS
Regulatory Affairs Associate
An RA Associate (sometimes known as Government Affairs Aassociate) ensures that companies comply with government regulations concerning their business. In the pharmaceutical business, RA will be ensuring that the companies comply with FDA or TPD regulations. Requirements include a life science degree, knowledge of the GxPs and ICH regulations.
Medical Writer
Medical Writers take complex and detailed scientific information and present it in a manner that is clear and easily understood by the intended audience, which may include medical professionals, the public, or regulatory bodies. Requirements for this position vary.
MANUFACTURING
Quality Assurance Associate
The role of Quality Assurance Specialist in the biopharmaceutical industry is to audit drug development process and procedures and ensure safety, purity and stability of material used in the process and the end product. Typical work activities include: ensure timely completion of routine QA procedures, manufacturing, packaging and Formulation Development in-process testing checks, sampling and other agreed upon duties and / or ensure implementing of good laboratory (GLP), good clinical practices (GCP) or good manufacturing practices (GMP) (emphasis depends on employer’s requirements and type of employer), ensure timely inspection, sign in and reconciliation of production rooms, equipment, raw materials and packaging components, report any non-conformances that are identified during routine operations monitoring and in-process testing in a timely manner to QA Supervisor and provide assistance in the Quality Notification investigation, ensure that of all phases of manufacturing, packaging and Formulation Development comply with relevant SOPs (Standard Operations Procedures), cGMPs (Good Manufacturing Practices) and safety guidelines, participate as a member of the Quality Assurance Dept., to develop, implement and conduct in-process quality inspections through the manufacturing and packaging facilities, assist in the development and execution of inspection systems that will track and report on production compliance metrics. Entry requirements vary but preferrably a degree in the life sciences, engineering, chemistry coupled with a good knowledge of GMP, FDA/TPD regulations. (See our training page for more information on Quality Assurance training)
Process Development Associate
These position includevarious scientists involved in the drug manufacturing process e.g. microbiologists, pharmacologists, assay developments scientists, immunologists, bioanalytics, etc.
SALES AND MARKETING
Pharmaceutical Sales Personnel
Involved in sales and marketing of finished pharmaceutical products. Among sales careers, pharmaceutical sales is one of the most revered due to excellent pay and perks and career advancement opportunities. Usually a science or commerce degree is required and excellent inter-personal and communication skills. Any special training is not required to enter a pharmaceutical sales career. But given the stiff competitionfor these positions, it is important to be well prepared before you get to the interview. There are a few institutions that offer pharmaceutical sales training and certification that would give you an edge during your job application. See our training page for more information on training for pharmaceutical sales career.
Business Development Personnel
These are involved in the developing the business process behind a drug/device including marketing and promotion, seeking new markets, analyzing business reports for the sake of improvement and related functions. Normally a life science or business degree coupled with an advanced degree (preferrably an MBA) is required. Other qualifications may be accepted.
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This list in not comprehensive but it gives a preview of the available positions in the industry. As mentioned earlier, some institutions like Kriger offer specialized training programs for biopharmaceutical careers. Please visit our Training for Biopharmaceutical Industry Careers page for more information.