Biological Scientist

About this role

Applicants must meet all qualifications and eligibility requirements by the closing date of the announcement including specialized experience and/or education, as defined below. Basic Requirements for Biologics Series, 0401: Degree: Biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position. Related degree may include genetics. OR A combination of education and experience: Specifically, you must have courses equivalent to a major, as shown above, plus appropriate experience or additional education.

AND In addition to meeting the basic education requirements described above, applicants must also meet additional qualification requirements as stated below: FOR THE GS-11: Applicants must demonstrate at least one full year of specialized experience equivalent to at least the GS-09 grade level in the Federal service. The specialized experience requirements for the GS-11 is fulfilled by having experience implementing and maintaining a laboratory Quality Management System (QMS) for biologics or comparable regulated products; performing quality audits; applying International Organization for Standardization standards (ISO)/Good Manufacturing Practice/Good Laboratory Practices (GMP/GLP) and biosafety standards; and authoring/revising SOPs and quality documentation in a high-containment or regulated laboratory setting.

OR Education: You must have a Ph.D. or equivalent doctoral degree in biology, genetics, computational biology, bioinformatics, statistics, or a directly related field. Related degree may include chemistry. OR A combination of doctorate-level education and specialized experience as described above. FOR THE GS-12: Applicants must demonstrate at least one full year of specialized experience equivalent to at least the GS-11 grade level in the Federal service.

The specialized experience requirements for the GS-12 is fulfilled by having experience leading implementation and continuous improvement of a laboratory Quality Management System (QMS) for biologics or comparable regulated products; conducting quality audits; applying ISO/GLP/GMP and biosafety standards; authoring/controlling SOPs and quality documentation; and using quality metrics and risk assessments to drive Corrective and Preventive Actions (CAPAs) in a high-containment or regulated laboratory environment.