Relocation expenses reimbursed Yes You may/may not qualify for reimbursement of relocation expenses in accordance with agency policy.
Degree: physical sciences, life sciences, or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics; OR,
Combination of education and experience -- course work equivalent to a major as shown in A above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education.
In addition to the meeting the basic requirement, you must have one (1) year of specialized experience equivalent to at least the GS-11 grade level in the Federal service, to include industry or related experience in research and development, formulation, analytical methodology, and or manufacturing assisting senior scientist with evaluating technical data reports on scientific results using modern analytical instrumentation including commercial statistical and data management software package to compile and process experimental data, and perform statistical analysis of data as assigned; and in regulatory method development and/or contract laboratory experience.
Note: To be considered for a Chemist position you must submit with your application an unofficial transcript(s) from an accredited college or university demonstrating you meet the education requirements listed above. See "Education" for information regarding Foreign Education.
Positions are located in throughout the following FDA Centers:
Center for Drug Evaluation & Research (CDER) - Provide regulatory oversight for investigational studies during drug development and making decisions regarding marketing approval for new (innovator or non- generic) drugs, including decisions related to changes to already marketed products.
Center for Devices and Radiological Health (CDRH) - Facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.
Center for Food Safety and Applied Nutrition (CFSAN) - Responsible for the safety of the nation's domestically produced and imported foods, cosmetics, drugs, biologics, medical devices, and radiological products.
Office of Regulatory Affairs (ORA) - Inspects regulated products and manufacturers, conducts sample analysis of regulated products and reviews imported products offered for entry into the United States.
Center for Veterinary Medicine (CVM) - Reviews animal drug applications for safety and effectiveness, monitors animal drugs, animal foods, and devices on the market, reviews food additives for safety and utility, and conducts research that helps FDA ensure the safety of animal drugs, food for animals, and food products made from animals. CVM fosters human and animal health by approving safe and effective products for animals and by enforcing applicable provisions of the Federal Food, Drug, and Cosmetic Act and other authorities. These include animals, from which human foods are derived, as well as pet (or companion) animals.
Center for Tobacco Products (CTP) - Set performance standards, review pre-market applications for new and modified risk tobacco products requiring new warning labels, and establishing and enforcing advertising and promotion restrictions.
Listed below are desired experience for the following centers:
CFSAN: Serve as regulatory (review) chemist in support of testing activities and other scientific investigations related to cosmetic products and ingredients. Determine what information or methods need to be developed to complete the various testing phases of the project. Maintain expert state-of-the-art knowledge of the particular area of research throughout the life of the project, reviewing available literature on new methods and techniques for potential application. Provide expertise for the development and selection of new methods for scientific investigation. Analyze research findings appropriate for guidance development, publication, and future reference by others. Collaborate with external stakeholders, including international regulatory health authorities and international industry organizations on issues related to cosmetic safety assessment.
CVM: Evaluate the identity, strength, quality, and purity of drug substances of new animal drug products. Evaluate acceptability of changes to bulk drug synthesis, formulation and manufacturing process of animal drug products. Determine whether animal drug products have adequate controls to prevent microbiological contamination. Conduct technical review of feed data to determine identity and acceptability of substances intended for use in animal feed. Determine if manufacturing processes and analytical controls are adequate to produce a consistent food ingredient with specified purity, potency, quality and strength. Analyze feed substances to determine the levels of contamination and ensure compliance with the Code of Federal Regulations.
CTP: Responsible for identifying, defining, and selecting specific problems for review, study and determining investigations and approaches to the problem area. Formulate hypotheses and develop and carry out the review of chemical studies, coping with novel, difficult, and unexpected problems. Perform key role in resolving issues that significantly affect scientific programs. Communicate scientifically, technical or complex concepts in writing. Communicate findings, interpretations and proposals orally.
ORA: perform method development and regulatory chemical analysis in the Atlanta Center for Tobacco Analysis (ACTA). The incumbent will operate and maintain GC/MS equipment (LC/MS knowledge and tobacco experience will be considered as a bonus). A background in regulatory method development and/or contract laboratory experience is also desirable to demonstrate the ability to process a significant number of samples in relatively short time frames.
CDER: Quality assessment for NDAs and ANDAs specifically focusing on the assessments of drug substance, product composition, product/process development, manufacturing process, reference standards, drug product controls, container closure, stability, and related regulations/policies. Evaluate identification and characterization of drug substance's physical, chemical, biological and mechanical properties and their impact on the drug product; Perform manufacturing processes and facilities used by foreign and domestic manufacturers of drug substances and/or products; Apply mastery of chemistry principles, practices and procedures including Process Analytical Technology to determine the adequacy of testing for raw materials and intermediates, the control of manufacturing processes, and the testing of the finished dosage forms; Participate in the facility inspections related to the evaluation of manufacturing processes and controls and in support of pre-approval and cGMP inspections.
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.
ADDITIONAL CONDITIONS OF EMPLOYMENT:
- If you are serving, or have served in the last 5 years (from September 25, 2018 ) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Political Appointee FAQ - OPM
- 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 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
- Bargaining Unit Position: Yes
- Veteran's Preference: If you plan to apply for any time of Veterans Preference, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See Veterans Preference for more.
- Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the Selective Service Registration site.
- Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See Individuals with Disabilities for more.
- Career Transition Assistance Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. See Career Transition Assistance for more.
- Financial disclosure statement, OGE-450, may be required: Please be advised that this position may 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..
You will be evaluated for this job based on how well you meet the qualifications above.
Once the job opportunity announcement closes (at 11:59 pm Eastern Time on September 25, 2018, a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether you are qualified for this particular position.
If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible, or your score may be adjusted to more accurately reflect your skills and abilities.
Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Basis of Rating: Category rating procedures will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be assigned to one of the following quality categories: Best Qualified, Well Qualified, or Qualified.
The Category Rating Process does not add veterans preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 30 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's directly, but your resume should contain sufficient information to demonstrate possession of the Competencies.
To preview the application assessment questions, click the link below:
https://apply.usastaffing.gov/ViewQuestionnaire/10303028 Read more Security clearance Q - Nonsensitive Drug test required No