Biotech-Related Job Descriptions
The descriptions given below are example career profiles provide a demonstration of the various positions in the biopharmaceutical industry cluster. An additional perspective from the California State University System on biotechnology industrial jobs is also of interest.
Opportunities for biologists range from B.S. level up through the doctorate, with an increasing emphasis on specialization and independent research at higher levels. Lower level positions such as Assistant Research Scientist involve basic lab functions like assay preparation. Advanced positions may require research design, the conduct and oversight of studies, and contribution to published findings. At every level, the biologist must be able to communicate their work to other members of the scientific team and to others.
A biostatistician gathers and analyzes data from clinical drug studies in order to demonstrate how the drug behaved in trials. This data is crucial to the development and regulatory processes. At the managerial level, biostatisticians will confirm that statistical methods are uniform across studies and will monitor the rigor of statistical analysis. Advanced biostatisticians interact with regulatory agencies during the drug approval process. A master's degree is usually required for this position.
A Chemist tests drug material for quality, purity and strength, using approved methodology and safety practices. They produce sample batches of a drug for trouble-shooting and help design the scaling-up process that takes drug manufacture up to factory proportions. Advanced positions require extensive record keeping and the supervision and integration of a lab team.
Clinical Data Manager
Clinical trials produce enormous amounts of data that a pharmaceutical/biotechnology company uses to achieve regulatory approval of a new drug. The clinical data manager helps to design and standardize the process for gathering and storing that data, as well as ensuring timelines are met.
A clinical programmer builds the databases which house the information gleaned from clinical trials of experimental drugs. The programmer must ensure that the databases conform to company standards in order to facilitate the use of the data in the regulatory process. At management levels, clinical programmers assist in the design of databases for specific trials and assure that lower level staff members have sufficient training to complete assigned databases.
Clinical Research Associate (CRA)
The CRA is the interface between the pharmaceutical company and the clinical sites conducting trials of experimental drugs, and as such, can be responsible for a wide variety of duties. These include writing study protocols, interacting with clinical practitioners, and interacting with QA/QC investigators and other site staff. An intricate knowledge of FDA guidelines is required. These positions usually require a BS, RN, or BSN degree.
Clinical Supply Manager
The clinical supply manager coordinates and ensures delivery of drug compounds for clinical trials, acquires bulk supplies from outside vendors, oversees appropriate labeling and packing activities, and facilitates the timely arrival of supplies to the testing sites. The clinical supply manager also manages inventory and recommends outsourcing within the company.
Drug Safety Professional
The drug safety professional knows and flags safety signals as they arise in trials, oversees the compilation of adverse event data and analyzes the data. This position may provide risk/benefit analysis and trial design input to clinical teams, marketing teams, labeling committees, regulatory officers and outside entities. The drug safety professional also ensures that drug safety data are gathered according to standard procedures.
The medical director is an expert in a disease area and therefore able to plan clinical trials in that area. The physician implements the approved plan, including budgeting and oversight, and acts as a knowledge resource to other departments by producing profiles of diseases in their specialty area. At a global level, the medical director may be responsible for the implementation of clinical trials in many countries, and may interface with outside entities to keep their opinion of the industry informed and up to date. The medical director provides medical and scientific leadership, guidance and expertise for products after market introduction by planning, managing and reporting phase II, III and IV clinical studies as well as investigator driven clinical studies.
Medical Writer/Technical Writer
The medical writer may be responsible for the writing and editing of clinical reports and study protocols, as well as submissions to the FDA. Medical writers may also be charged with the production and publication of peer-reviewed scientific papers explaining the result of clinical studies.
The microbiologists perform tests on microorganisms and bacteria in the environment around manufacturing areas, conduct lab tests in support of process validation studies, grade water used in manufacturing, and perform other testing functions to support the operations, legal compliance and regulatory documentation.
The pathologist's role is to design, carry out, report on, and analyze data from pre-clinical animal toxicity trials of potential drug compounds. The pathologist also engages in profiling the mechanisms of toxicity for the purpose of designing less toxic compounds in the future, and serves on the committees that see a compound from late pre-clinical through early clinical stage trials. This position requires a medical degree as well as a license to practice medicine.
Process Engineer/Manufacturing Engineer
This position designs, installs and troubleshoots manufacturing equipment, helps plan and record safety procedures to ensure a high quality product, investigates quality control problems, and tries to improve the manufacturing process to promote better manufacturing times and the highest quality product.
Quality Assurance Engineer
Similar to the manufacturing engineer, the quality assurance engineer is heavily engaged in the manufacturing process. This position develops protocols to ensure a consistently pure, high-quality product, oversees protocol implementation and checks product quality levels. In case of quality problems, the quality assurance engineer works with the manufacturing staff to rectify the issue.
Quality Control Analyst
The quality control analyst is responsible for developing formalized product testing procedures, and for writing and de-bugging the scripts to run the procedures. This position also assists in the selection and use of testing tools and confirms that any additions or fixes to the testing system do not disrupt other components.
Regulatory Affairs Specialist
Drug approval and marketing is the primary objective of a pharmaceutical company. The regulatory affairs specialist is an expert in regulatory requirements, assures that those requirements have been met in drug approval studies, and at higher levels interfaces with the FDA in the approval process and in post-marketing follow-up in order to ensure the largest possible market for a product.
As part of the pre-clinical team, a toxicologist's job is to examine the toxicity of potential drug compounds at the molecular level. With the advancement of genetic technology, toxicology increasingly uses the tools of genetics such as micro arrays and protein characterizations to examine toxic interactions.
An integral part of the quality assurance process, the validation engineer develops and writes manufacturing validation protocols, implements the protocols in keeping with regulatory requirements, and tracks and reports on validation measures. He or she operates from the physical level of calibrating production machinery through such managerial functions as time budgeting for validations processes.