Biological Scientist

US Department of Agriculture (USDA) Agricultural Research Service (ARS); Manhattan (KS); On-site; USD 80,000 - 110,000; Full time

Job summary

The Agricultural Research Service (ARS) is seeking a qualified candidate to support the NBAF Quality and Select Agent Program Management Unit in advancing a comprehensive quality assurance management system. This role focuses on ensuring top-tier operations, regulatory compliance, and scientific integrity across the biologics program.

You will collaborate with the Quality Assurance Manager and the Biologics Development Module Director to develop and implement policies and procedures governing

Qualifications

• Degree or education/experience combination as described for Biologics.
• GS-11 requires 1 year of specialized experience in QMS, audits, ISO/GMP/GLP, biosafety, SOPs.
• GS-12 requires leadership of QMS improvements, audits, SOPs, CAPAs in regulated labs.

Responsibilities

• Develop and implement a quality assurance management system.
• Coordinate with QA Manager and BD Module Director on quality policies.
• Ensure compliance with ISO/GLP/GMP and biosafety standards in a high-containment setting.

Skills

Quality management

Quality audits

SOP development

Regulatory compliance

Education

Biological sciences / related

Job description

Summary

This position is in the Quality and Select Agent Program Management Unit. Their mission is to ensure the highest standards of NBAF operations, regulatory Biologics Development Module compliance, and ARS scientific integrity. The incumbent coordinates with the Quality Assurance Manager and the Biologics Development Module Director to develop and implement a quality assurance management system consisting of specific policies/processes/procedures involving the technological transfer of vaccines,

Duties

This position is in the Quality and Select Agent Program Management Unit. Their mission is to ensure the highest standards of NBAF operations, regulatory Biologics Development Module compliance, and ARS scientific integrity. The incumbent coordinates with the Quality Assurance Manager and the Biologics Development Module Director to develop and implement a quality assurance management system consisting of specific policies/processes/procedures involving the technological transfer of vaccines,

Requirements

Qualifications

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.

Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.

The Agricultural Research Service is the U.S. Department of Agriculture's chief scientific in-house research agency. Our job is finding solutions to agricultural problems that affect Americans every day from field to table. What we do matters in science and the world. For more information about Agricultural Research Service, go to https://www.ars.usda.gov/.