The National Institutes of Health (NIH) is the premier biomedical research center for the world.
Its 27 Institutes and Centers employ approximately 18,000 employees doing a vast array of jobs, all supporting efforts for a healthy nation.
For information on the NIH mission, goals, and Institutes and Centers, visit NIH Overview.
The NIH Clinical Center Pharmacy Department provides pharmaceutical care to inpatients and outpatients on NIH intramural research protocols at the NIH Clinical Center.
The Clinical Center facility encompasses 200 inpatient beds, 93 day-hospital stations, and 15 clinics.
Clinical Center pharmacy staff provide sophisticated research support to health care providers as well as clinical investigators.
Pharmacists conduct and participate in research programs that enhance knowledge regarding investigational drugs and new uses of commercially available agents.
The Supervisory Pharmacist in IDOU serves in the NIH CC Pharmacy Department with responsibility for the investigational drugs manufactured by CMOs used in clinical studies at the NIH.
This unit develops and brings to human trials items which have been or not been patented.
Many of the functions carried out are required by federal laws.
General operations of the Investigational Drug Outsourcing Unit include the identification of the requirements for drug related aspects of protocols, obtaining appropriate quotes from the vendors, reviewing manufacturing documents and acting as legal custodians of drugs outsourced by NIH.
The ideal candidate will be an exceptionally talented, knowledgeable, and motivated pharmacist with extensive experience with drug manufacturing in the pharmaceutical industry and management of contract manufacturing organizations (CMO).
The ideal candidate will be able to demonstrate a mastery of federal regulations on current Good Manufacturing Practice (cGMP) and every aspect of the manufacturing process.
Previous management experience of manufacturing and outsourcing is highly desired for this position.
Clinical Center video
Basic Qualification Requirements: Education: 4-year bachelors degree in Pharmacy recognized by the Accreditation Council for Pharmacy Education (formerly known as American Council on Pharmaceutical Education); OR 5-year course of study leading to a bachelor's or higher degree in Pharmacy by the Accreditation Council for Pharmacy Education; OR 6-year course of study leading to a Doctor of Pharmacy (Pharm.D.) degree.
Licensure: All applicants must be licensed to practice in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.
Additional Requirements: In additional to meeting the basic requirements, the following amount of specialized experience is required to qualify for positions at GS-14.
You must demonstrate in your resume at least one year of qualifying experience equivalent to at least the GS-13 level in the federal government obtained in either the private or public sector, performing the following types of tasks: providing technical advice to investigators of pharmaceuticals in clinical protocols, addressing dosage form, batch size, outsourcing or manufacturing process, production time and frame of supplies; Developing investigational agent acquisition and procurement strategies; Coordinating delivery, use and inventory of manufactured pharmaceuticals and investigational agents; Developing and reviewing drug manufacturing proposals in terms of quality control, costs, specific dosage forms, proper batch size, drug stability, release criteria and microbial control. https://apply.usastaffing.gov/ViewQuestionnaire/10033241