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