Supervisory Chemist

Duties

As a Supervisory Chemist you will perform the following duties: 

• Plans, manages, organizes and directs all laboratory functions and activities of the Division as carried out by a highly trained and skilled staff of scientific professionals.
• Provides leadership and direction in strengthening the operation and scientific management of the Division.
• Provides input into guidance documents for industry and into establishing analytical methodologies.
• Develops partnerships and coordinate collaborations with academic institutions, instrument manufacturers, FDA's other center laboratories, Office of Regulatory Affairs, and National Center for Toxicological Research (NCTR) on research programs, projects and activities that support and are complimentary to the FDA mission.
• Provides continuous improvement of in vitro methodologies to predict in vivo drug release performance so drug release can be assessed following changes to formulations and manufacturing and drug release of generic and innovator products;
• Uses advanced techniques to evaluate complex drug substances such as heparin, insulin, conjugated estrogens and biotechnology derived active pharmaceutical ingredients;
• Develops analytical methodology to assess quality of novel dosage forms such as nanotechnology drug products, transdermal drug products and inhalation drug products;
• Assigns work to subordinates based on priorities, selective consideration of the difficulty and requirements of assignments, and the capabilities of subordinates; evaluates the work performance of subordinates.

Qualifications

In order to qualify for Supervisory Chemist, GS-1320-15, you must meet the following:

Basic Qualification:

Degree: physical sciences, life sciences, or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics.

or

Combination of education and experience -- course work equivalent to a major as shown in A above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education.

Transcripts must be provided with your application for qualifications based on the education requirement.

In addition to the basic qualification requirements, applicants must meet the specialized experience as stated below.

Minimum Qualification: Applicants must have one year of specialized experience, equivalent to the GS-14 level of difficulty and responsibility in the Federal service to include: 1) Providing overall management and direction of a highly technical staff involved in pharmaceutical analysis while planning and developing new programs and projects; 2) Serving as principal advisor in all matters related to planning, developing and administering the pharmaceutical analysis program and state-of-the-art technology; 3) Using quantitative analytical methods critical to the regulation of all human drug products; and 4) Developing leadership on broad scientific and regulatory activities involving in vitro analytical quality research activities. 

Documenting experience:  In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description.  Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.

Education

If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program. For further information, click on foreign education.