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Career profiles

>> BioSpace.com career profiles give you a snapshot of the differing positions within the biopharmaceutical industry, including required education, and potential for advancement.

>> Biologist

Opportunities for biologists range from B.S level up through the doctorate, with an increasing emphasis on specialization at higher levels. Lower level positions such as Assistant Research Biologist involve basic lab functions like assay prep. Advanced positions require research design, the conduct and oversight of studies, and contribution to published findings. At every level, the biologist must be able to communicate his or her work to other members of the scientific team and to other departments, such as marketing.

>> Biostatistician

A biostatistician gathers and analyzes data from 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.

>> Chemist

Chemists test drug materials 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 vast amounts of data that a pharmaceutical 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.

>> Clinical Programmer

The 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.

>> CRA (Clinical Research Associate)

The CRA is the interface between the pharmaceutical company and the healthcare 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 physicians, and interacting with investigators and other site staff. An intricate knowledge of FDA guidelines is required. These positions usually require a BS, RN, or BSN degree, and require some travel.

>> Clinical Supply Manager

The clinical supply manager coordinates and ensures delivery of drug compounds for clinical trials, procures bulk supplies from outside vendors as needed, oversees appropriate labeling and packing issues, and facilitates the timely arrival of supplies at testing sites. The clinical supply manager also forecasts supply need and recommends outsourcing opportunities to relevant governance units within the company.

>> Drug Safety Specialist

The drug safety specialist knows and flags safety signals as they arise in trials, oversees the compilation of adverse event data and analyzes the data. He or she provides risk/benefit analysis and trial design input to clinical teams, marketing teams, labeling committees, regulatory officers and outside entities. The drug safety specialist also ensures that drug safety data are gathered according to standard procedures.

>> Medical Director

The medical director is an expert in a disease area and therefore able to plan a late-stage clinical trial in that area. He or she implements the approved plan, including budgeting and oversight, and acts as a knowledge resource to other departments by producing profiles of diseases in his or her area. At a global level, the medical director is 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. Provides Medical and Scientific leadership, guidance and expertise for products after market introduction by planning, managing and reporting phase IIIB and IV clinical studies as well as investigator driven clinical studies.

>> Medical Writer/Technical Writer

The duties of the medical writer include 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.

>> Microbiologist

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 operations, legal compliance and regulatory documentation.

>> Pathologist

The pathologist’s role is to design, carry out, report on and analyze data from pre-clinical animal toxicity trials of potential drug compounds. This scientist 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

In this position the employee 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

Like the manufacturing engineer, the quality assurance engineer is heavily engaged in the manufacturing process. He or she 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. He or she 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 raison d’etre 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.

>> Toxicologist

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 microarrays and protein characterizations to examine toxic interactions.

>> Validation Engineer

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.

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