For the GS-14 grade level, applicants must have 52 weeks in a non-temporary appointment at the GS-13 grade level in the Federal Service.
Interfacing with multidisciplinary teams pertaining to New Drug Applications (NDAs) and Investigational New Drug Applications (INDs) involving the application of the Food, Drug and Cosmetic Act and other applicable rules and regulations for human drugs; performing timely, high quality Chemistry, Manufacturing and Controls (CMC) review of new molecular entities, complex formulations and manufacturing processes; independently resolving technical issues of exceptional complexity and scope; applying the principles, theories, and practices of chemistry, technology, quality and other concerns associated with manufacturing processes and controls involved in research, development, and production of drugs for human use; drawing scientifically sound conclusions from a wide array of publications and studies in order to make cogent recommendations; completing reviews of quality-by-design (QbD) based submissions (individually or as a team member); contributing to CMC reviewer training activities on emerging regulatory or scientific issues.
Documenting experience: In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.
Conditions of Employment:
1. Additional Security and Background Requirements: May be referred depending on the position being filled. 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 reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection and/or appropriate disciplinary action.
2. All qualification requirements must be met by the closing date of the announcement.
3. Financial disclosure statement may be required.
4. Travel, transportation, and relocation expenses will be paid: No
5. Bargaining Unit Position: Yes
6. Drug Screening Required: No
7. Recruitment Bonus may be authorized: No
8. Research position: No
9. Supervisory position: No
10. Time in grade (TIG) must be met within 30 days of the closing date of the announcement.
HOW YOU WILL BE EVALUATED:
Once the application process is complete, a review of the resume and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your qualifications and/or experience, you may lose consideration for this position. Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Your qualifications will be evaluated and rated on the following competencies (knowledge, skills, abilities and other characteristics):
Mastery of the theories, principles, and methods in the chemistry and associated scientific disciplines.
Knowledge and understanding of applicable laws, regulations, policies, procedures, standards and guidelines pertaining to human drugs.
Skill to identify problems, such as flawed studies or questionable results, and to recommend solutions.
Thorough knowledge and understanding of pharmaceutical dosage form development, process development, and manufacturing.
Ability to communicate in writing.
Ability to communicate orally.