What does working as an FDA chemist involve
The US Food and Drink Administration (FDA) employs thousands of people to work in their various departments and require everything from administrators through to chemists. This is similar to the Medicines and Healthcare products Regulatory Agency in the United Kingdom and both bodies are responsible for licencing drugs that can be used for a variety of illnesses based upon the results of Paid Medical Trials that are undertaken by companies such as trials 4 us. These two agencies will work closely together when new drugs are trialled and reported on.
Here is a more detailed look at the role of a chemist within the FDA.
Duties of FDA chemists
The duties of a chemist working for the FDA include the review and evaluation of NDAs (New Drug Applications). This involves evaluating the characterisation and identification of the mechanical, physical, biological and chemical properties of the drug substance and how they impact on the product.
You would also evaluate the manufacturing processes including the adequacy of facilities, methods and controls used in the manufacture of drug products.
A chemist working for the FDA would also review proposed labels, summarise findings and recommend whether or not the application should be approved.
The candidate may also be involved in finding clinical staffing solutions and conducting research projects, for example studying the effects of dietary supplements and components of food on the utilisation of essential and toxic minerals in dieters.
Additionally, work might include investigating how drugs, agricultural chemicals and antibiotics affect cattle, other domestic livestock and small laboratory animals.
According to Reuters, 21 grants for research into the development of products for rare diseases have recently been awarded by the FDA.
All grades of FDA chemists require a degree. This can be in life sciences, physical sciences or engineering and must include a minimum of 30 semester hours in chemistry, 6 hours in physics and coursework in mathematics. Additionally, the recruiters will be looking for appropriate experience or additional education.
One year’s specialised experience will also be needed. This will be equivalent to the GS-12 (federal service) and will include participation in the review and analysis of aspects of the drug manufacturing process, as well as identifying deficiencies or problems in the processes.
At headquarters level, these are generally GS-9 through 13, whilst at the field level they are GS-5 through 12. To qualify for the higher graded positions, candidates would be expected to demonstrate additional directly related education or specialised experience. The amount of this that would be required would depend on the specific grade of the position.