Version: 11/2021

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 Human and Animal Food Laboratory Operations (OHAFLO)

Irvine Human & Animal Food Laboratory (IRVLHAF)

Chemist (Advanced Analyst)

Application Period: December 8, 2023 – February 8, 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: Chemist (Advanced Analyst) Series: AD-1320

Location(s): Irvine, CA

Work Schedule: Full Time

Salary: Starting at $112,015

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

Travel Requirements: Up to 25% travel is required.

Bargaining Unit: This is a bargaining unit position.

Hiring Incentives: Incentives may be authorized; however, this is contingent upon funds 

availability. 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 the 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 
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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 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 mission of the Office of Regulatory Affairs (ORA) 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/fdaorganization/office-regulatory-affairs. 

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 and 12 laboratories throughout the United 

States. 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 FDAregulated 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 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 Human & Animal Food Laboratory Operations (OHAFLO) advises the ORS on 

scientific issues related to human and animal food laboratory operations and provides strategic 

leadership and support for high quality, collaborative, scientific activities that advance 

regulatory science and address important public health issues concerning the Food and Drug 

Administration (FDA) regulated products, including their evaluation, quality, safety, and 

effectiveness.

Duties/Responsibilities

The Chemist (Advanced Analyst) serves as an analytical instrumentation specialist within the 

Irvine Human and Animal Food Laboratory (IRVLHAF) where they are recognized as the expert, 

technical authority, and resource person in this specialization. Examples of highly technical 

chemistry instrumentation include—but are not limited to: Liquid or Gas Chromatography with 

Tandem Mass Spectrometry (LC-MS/MS)/ triple quadrupole mass spectrometer (QQQ), Highperformance liquid chromatography (HPLC, Mass Spectrometry (MS), and Electron Microscopy 
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(EM). 

Conducts sample analysis using approved analytical procedures in various areas of agency 

concern to identify and quantify contaminants and adulterants in FDA-regulated products. 

Formulates and conducts research that evaluates new chemistry instrumentation and its 

applicability to the required analyses. Plans and performs the development of analytical 

methods in accordance with FDA needs and priorities, which requires a strong understanding of 

the ISO 17025 accreditation, Guidelines for the Validation of Chemical Methods in Food, Feed, 

Cosmetics and Veterinary Products and per local Standard Operating Procedure. Performs 

verifications and validations of new chemistry methods.

Serves as a technical expert and scientific advisor in the specialty area of chemistry 

instrumentation and analytical software applications. The incumbent is responsible for

addressing methodology problems encountered by other ORA field professionals. 

Troubleshoots instrumentation issues and problems that arise when evaluating data such as 

contamination control, poor sensitively, reasons for Quality Control failures, incomplete 

extraction, and other method performance problems. Participates in internal planning to make 

recommendations to management related to the future needs of the laboratory such as new 

analytical instruments and methods of analysis.

May be required to organize and present seminars and training sessions on specialized 

chemistry instrumentation and technical areas specifically related to analytical methods and 

research. As needs dictate, training may be given at any FDA location. Training may be provided 

to visiting foreign scientists, other Federal, state, and local government agencies as well as FDA 

personnel. May participate in interagency programs in training and quality assurance that 

involves area of specialty. Writes professional reports of findings and offers them for 

publication in recognized scientific journals and in-house bulletins. When requested, reviews 

methods to be used by the agency in the United States Pharmacopoeia and other compendia, 

and the scientific papers offered by other scientists for publication and judges the level of their 

contribution to present knowledge in specialty area and their suitability for publication. 

Testifies in court as an expert witness in specialty field.

Supervisory Responsibilities: This is not a supervisory role.

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 
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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. Qualified and Outstanding Candidates

a. Qualified applies to all candidates for Title 21 appointments. The FDA OTS will 

use the basic requirements defined in the Title 21 qualification standards as a 

baseline for comparing experience levels and other candidate attributes for 

relevant positions.

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

outstanding performance rating, or both.

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: Candidates must possess a bachelor’s degree or higher in chemistry, 

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

institution. 

Additional Requirements: 

• This position requires up to 25% travel.

• The work requires some physical exertion, while working in labs such as, recurring 

bending, crouching, stooping, stretching, reaching, or similar activities while wearing 

protective clothing and gear.

• Work environment involves regular and recurring exposure to irritant chemical and 

biological hazards, toxic and flammable solvents, high voltage electronic equipment and 

in some cases intense electromagnetic radiation. Special precautions may be required, 
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and the scientist may be required to use protective clothing and gear such as a 

laboratory coat, safety glasses, gloves, mask, etc.

Desired Education: Advanced degree. 

Desired Skills and Professional Experience: 

• Master and skill in applying expertise in advanced professional theories, principles, 

concepts, standards, and methods sufficient to conceive and apply experimental 

theories and new development applications to extend and modify theories, concepts, 

and assumptions; resolve unique or novel problems, conditions, and issues; and 

significantly alter standard practices, equipment, devices, processes, and known 

techniques. 

• Mastery of the principles, theories, and practices of a specialized instruments for the 

chemical analysis of target compounds in FDA regulated products.

• Fully knowledgeable on the ISO 17025 standard as it applies to the laboratory programs 

incumbent is assigned to or supports.

• Comprehensive knowledge of Federal laws, agency regulations and guidelines in their 

specialized field and of FDA regulatory programs to sufficiently evaluate and incorporate 

the latest developments and changes in the specialized instrument field into the agency 

guidelines and criteria.

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. 
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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 based on 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 

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 need

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

needs accommodation to perform the essential job duties or to gain access to the workplace.

An employee with a disability needs accommodation to receive equal access to benefits, such 

as details, training, and office-sponsored events. You can request 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 
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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 by all qualified applicants. Applicants must submit a letter of 

interest addressing experience in the major duties and responsibilities of the position, a 

detailed current resume, SF-50 (redacted for SSN and birth year, for federal employees only) 

and college transcript(s) (with foreign credentials evaluation, if applicable) to the ORA Executive 

Recruitment and Scientific Staffing Committee: 

ORAExecutiveandScientificRecruitment@fda.hhs.gov. Applications will be accepted through 

February 8, 2024. Applicants must reference 4-Chemist-Irvine in the email subject line. 

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 smokefree environment. 

FDA is an equal opportunity employer.