Title 21 Vacancy Announcement

Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Office of Regulatory Affairs (ORA)

Office of Regulatory Science (ORS)

Office of Medical Products and Specialty Laboratory Operations (OMPSLO)

Detroit Laboratory

Application Period: January 12, 2024 – January 31, 2024

Area of Consideration: United States Citizenship is required. You must be a U.S. Citizen or U.S. 

National. Foreign nationals or legal permanent residents are not eligible for consideration.

Position: Laboratory Director Series: AD-1320

Location(s): Detroit, MI

Work Schedule: Full Time

Salary: Starting at $163,964

Title 21 Band(s): Band E Full Performance Band Level: Band E

Travel Requirements: Up to 25% travel

Bargaining Unit: This is a non-bargaining unit position.

Incentives: Incentives may be authorized; however, this is contingent upon availability of funds. If 

authorized, certain incentives will require you to sign a service agreement to remain in the Federal 

government for a period of up to 4 years. Note: This statement does not imply nor guarantee an 

incentive will be offered and paid. Incentives may include recruitment or relocation incentives in 

accordance with FDA, Title 21 Policy.

This position is being filled under a stream-lined hiring authority, Title 21, section 3072, of the 21st Century 

Cures Act. The candidate selected for this position will serve under a career or 

career-conditional appointment and be paid under the provisions of this authority.

Additional information on 21st Century Cures Act can be found here:

21st Century Cures Act Information

Introduction 

The Food and Drug Administration is the regulatory, scientific, public health, and consumer 

protection agency responsible for ensuring that all human and animal drugs, and medical devices 

are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food 

producing animals, and radiation emitting devices are safe, and that all such products marketed in 

the United States are adequately, truthfully and informatively labeled and safely and properly 
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stored, transported, manufactured, packaged and regulated. FDA’s programs are national in scope 

and effect, and the agency’s activities have a direct and significant impact on multi-billion-dollar 

industries, in addition to protecting the health and safety of American Consumers. The work of the 

Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other 

personnel stationed throughout the United States.

The Office of Regulatory Affairs (ORA) is at the forefront of building a public health safety net for 

today’s complex, global regulatory environment. ORA professionals work in a range of program 

areas and locations, with 227 offices, 15 laboratories, and 3 satellite laboratories throughout the 

United States and ports of entry. As the lead office for all FDA field activities, ORA serves as the 

agency’s direct connection with regulated industry through a) inspections of firms and plants 

producing FDA-regulated products, b) investigations of consumer complaints, emergencies and 

criminal activity, c) enforcement of FDA regulations, d) sample collection and analysis, and e) 

review of imported products. 

The mission of the Office of Regulatory Affairs is to protect consumers/patients and enhance public 

health by ensuring timely access to safe, quality FDA-regulated products. To view our ORA Vision, 

Mission, and Values please visit: https://www.fda.gov/about-fda/fda-organization/officeregulatory-affairs.

The Office of Regulatory Science (ORS) provides strategic leadership, coordination, and expertise to 

the Associate Commissioner for Regulatory Affairs (ACRA), Deputy Associate Commissioner for 

Regulatory Affairs (DACRA) and other ORA senior leaders on scientific issues related to policy and 

regulations.

The Office of Medical Products and Specialty Laboratory Operations (OMPSLO) advises ORS on 

scientific issues related to medical products, tobacco, drugs, electronic product radiation, medical 

devices, pharmaceuticals, radiopharmaceuticals, radionuclides in food, biological and 

microbiological safety of radiopharmaceuticals, and forensic chemistry.

The fundamental mission of the Detroit Laboratory (DETL) is to utilize the resources of the DETL to 

protect the public health by helping to assure the safety of foods, drugs and other FDA regulated 

products. Furthermore, DETL specializes in the testing of pharmaceutical based samples. The 

laboratory staff has unique expertise in the areas of drug analysis, chromatography, spectroscopy, 

environmental screening, and microbial analysis. In addition to scientific analysis, the laboratory 

staff supports the Investigations Branch in conducting pre-approval, compliance, and for cause, and 

surveillance inspections.

Duties/Responsibilities 

The incumbent serves as the Laboratory Director within OMPSLO, ORS, ORA, and as such, the 

incumbent reports directly to the Deputy Associate Director, OMPSLO, and is a member of the 

program’s management team. Additionally, the incumbent brings to bear current scientific 

knowledge in analytical forensics and related technologies in making substantive decisions 

concerning the scientific process and work of the DETL staff and serves as the subject matter expert 

for ORA in the analysis and testing of pharmaceutical based samples and medical products, and the 
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regulation of food and cosmetics. 

• Advises the Deputy Associate Director, OMPSLO, and ORA leaders on new or emerging 

problems and trends, future program needs and priorities, manpower, equipment, financial 

needs, and long-range planning.

• Serves as the principal spokesperson for the DETL, the incumbent will represent the DETL as 

the senior scientist with both internal and external constituencies and provides executive 

leadership and managerial direction to the DETL scientists and support personnel.

• Responsible for developing, maintaining, and applying state of the art expertise in drug 

analysis and research as it applies to Agency needs, as well as providing expert advice to 

Agency officials as well as testimony regarding drug analysis and research issues.

• Develops and maintains the capability to respond immediately to all tampering/terrorism 

and other incidents, including rapid development of required new methodology, analysis of 

samples and critical evaluation of results.

• Designs and conducts experiments to demonstrate the physical and chemical effects of 

poisons on food and drug products and studies the effects of the food and drug products on 

the stability and toxicity of the poisons.

• Develops procedures that can be used to establish chemical profiles of poisons and other 

deleterious substances that might be in foods and drugs.

• Ensures that program evaluation reviews, quality assurance and quality management 

systems, strategies, measures, and economical operating practices are in place to promote 

the effective execution of work plans, conformance to policy and safe working practices.

• Develops physical, chemical, and molecular/microbiological analytical procedures that can 

be used to further investigations and to provide evidence in cases of fraudulent activities 

involving foods, drugs and other FDA regulated products.

• Develops analytical procedures that can be used to further investigations and to provide 

evidence in cases of fraudulent activities involving pharmaceutical products. Provides 

strategic leadership and support for high quality, collaborative, scientific activities, and 

research that advance regulatory science and address important public health issues 

concerning FDA regulated products, including their evaluation, quality, safety, and 

effectiveness. Coordinates with other Agency components (e.g., Center for Drug Evaluation 

and Research) on ORA scientific programs to assure a cohesive approach to public health 

protection.

Supervisory Responsibilities: The Laboratory Director serves as a second-level supervisor and is 

responsible for the effective utilization of available resources and for providing leadership, 

guidance, and technical direction necessary for full and effective program accomplishments of the 

laboratory functions. The Laboratory Director is responsible for managing all phases of laboratory 

analyses in connection with samples of FDA-regulated commodities assigned to the laboratory for 

testing and analysis. The Laboratory Director supervises a staff of professional scientists, 

technicians, and support positions and is responsible for the functions of the Laboratory, including: 

planning, scheduling, and controlling laboratory operations; and formulating, implementing, and 

coordinating laboratory work plans.
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Conditions of Employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date. 

• Employment is subject to the successful completion of a background investigation, verification 

of qualifications, completion of onboarding forms, submission of required documents, and any 

other job-related requirement before or after appointment.

• Applicants must meet all qualification requirements by the closing date of this announcement.

• Direct Deposit: You will be required to have all federal salary payments electronically deposited 

into a bank account with a financial institution of your choice.

• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be 

processed through e-Verify to determine your employment eligibility. If a discrepancy arises, 

you must take affirmative steps to resolve the matter.

• Males born after December 31, 1959, must be registered with the Selective Service.

• One-year probationary period may be required. 

• Financial Disclosure may be required.

• Ethics Clearance may be required. 

• Background Investigation/Security Clearance is required. All employees must pass a security 

investigation. Failing to pass the background check may be grounds for removal or legal action. 

If hired, you may be subject to additional investigations at a later time. 

Qualifications 

To be placed into a Title 21 position, candidates must meet the following criteria:

1. Scientific, Technical, and Professional Fields

2. Outstanding and Qualified Candidates

a. Outstanding candidates can be defined by existing outstanding work experience, 

outstanding performance rating, or both.

b. Qualified applies to all candidates for Title 21 appointments. 

In order to qualify for this Title 21 position, the candidate(s) must meet the following required

qualifications. Please note: Additional education and experience listed that is not indicated as 

required is preferable and desired. Candidates who do not meet the “desired” criteria will not be 

excluded from consideration for this position. 

Education Requirement: A bachelor’s degree or higher in chemistry, biochemistry, or 

molecular/cellular biology. The degree must be from an accredited program or institution.

Position’s Desired Skills, Experience, or Education: 

• Experience with analytical problem solving, FDA law and associated criminal and civil 

enforcement is desired. 

• Experience with technology transfer and public private partnerships is valued. 

• Demonstrated networking skills including scientific collaboration with industry and 

academic partners is desired. 

• Advanced Degree at Ph.D. level is valued. 

• Demonstrated supervisory leadership and organizational management skills are valued. 
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• This position may require the incumbent to successfully obtain and maintain a secret 

security clearance.

Education Transcripts 

SUBMITTING YOUR TRANSCRIPTS: Positions which are scientific or technical in nature often have 

very specific educational requirements. A transcript is required to verify educational achievement. 

Pay careful attention to the Qualifications and Education sections to identify vacancies where a 

transcript is required. Even if you hold a similar position or are a current FDA employee, you are not 

exempt from transcript requirements.

FOREIGN EDUCATION: 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; or full credit has been given for the courses at a U.S. accredited college or university. For

more information about this requirement, please visit the U.S. Department of Education website 

for Foreign Education Evaluation. 

Security Clearance Requirements 

Background Investigation/Security Clearance Requirements: If not previously completed, a 

background security investigation will be required for all appointees. Appointment will be subject 

to the applicant’s successful completion of a background security investigation and favorable 

adjudication. Failure to successfully meet these requirements may be grounds for appropriate 

personnel action. In addition, if hired, a background security investigation or supplemental 

investigation may be required later. 

Ethics Clearance Requirements

This position may require financial disclosure reporting and will be subject to FDA's prohibited 

financial interest regulation. If you are hired, you may be required to divest of certain financial 

interests. You are advised to seek additional information on this requirement from the hiring 

official before accepting any job offers. For more information, please visit the FDA Ethics web page: 

https://www.fda.gov/about-fda/jobs-and-training-fda/ethics. 

Equal Employment Opportunity 

The United States Government does not discriminate in employment on the basis of race, color, 

religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual 

orientation, marital status, disability, genetic information, age, membership in an employee 

organization, retaliation, parental status, military service, or other non-merit factor.

Equal Employment Opportunity (EEO) for federal employees & job applicants

Reasonable Accommodation

Federal agencies must provide reasonable accommodation to applicants with disabilities where 

appropriate. Applicants requiring reasonable accommodation for any part of the application 
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process should follow the instructions in the job opportunity announcement. For any part of the 

remaining hiring process, applicants should contact the hiring agency directly. Determinations on 

requests for reasonable accommodation will be made on a case-by-case basis. A reasonable 

accommodation is any change to a job, the work environment, or the way things are usually done 

that enables an individual with a disability to apply for a job, perform job duties or receive equal 

access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide 

reasonable accommodations when: An applicant with a disability needs an accommodation to have 

an equal opportunity to apply for a job. An employee with a disability needs an accommodation to 

perform the essential job duties or to gain access to the workplace. An employee with a disability 

needs an accommodation to receive equal access to benefits, such as details, training, and officesponsored events. You can request a reasonable accommodation at any time during the application 

or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more 

about disability employment and reasonable accommodations or how to contact an agency.

E-Verify

The Food and Drug Administration participates in the USCIS Electronic Employment Eligibility 

Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new 

hires and the validity of their Social Security numbers.

How to Apply

Applications will be accepted from all qualified applicants. Please email letter of interest addressing 

your experience in the major duties and responsibilities of the position, résumé, transcript (with 

foreign credentials evaluation, if applicable), and current SF-50 (redacted for birth year and SSN; 

applies to current federal employees only) to the ORA Executive Recruitment and Scientific Staffing 

Committee: ORAExecutiveAndScientificRecruitment@fda.hhs.gov. 

IMPORTANT: You must reference this Job ID in the email subject line: 52-Laboratory Director, DETL 

Applications will be accepted through January 31, 2024. 

Announcement Contact

For questions regarding this Title 21 position, please contact 

ORAExecutiveAndScientificRecruitment@fda.hhs.gov

The Department of Health and Human Services is an equal opportunity employer with a 

smoke-free environment.

FDA is an equal opportunity employer.