Chemist (Analytical) & (Regulatory)
Relocation expenses reimbursed No
Degree: bachelor's or higher level degree from an accredited college or university in 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.
Combination of education and experience course work equivalent to a major as shown 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.
Additional Qualifications at the GS-13 level:
In addition, you must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-12 level in the Federal service obtained in either the private or public sector, performing the following types of tasks:
Chemist (Regulatory) tasks: experience with overall regulatory assurance and in depth knowledge of cGMP/GLP regulations and standards; ensure manufacturing, quality control and product release procedures are in a state of control and in accordance with PET cGMP and USP guidelines; ability to author and review SOPs, maintain controlled documents, review logs and batch records, accept incoming materials, perform internal audits, and support quality event system investigations, e.g., deviations, out of specification, and corrective and preventive actions;
Chemist (Analytical) tasks: experience with Quality Control (QC) testing of manufactured PET Drug Products as set forth in federal regulations; knowledge of method development and validation, analytical chemistry, and instrumentation (HPLC, GC, MS, etc.); QC experience within the cGMP/GLP environment and ability to perform analytical QC testing and release PET Drugs and key intermediates.
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, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.
Preview assessment questionnaire before you apply:https://apply.usastaffing.gov/ViewQuestionnaire/10476406
This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. Click here for information on Foreign Education.
If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application.
This position is designated as an 'emergency' position and the selected candidate will be considered an 'emergency' employee and will be required to be available, ready, willing, and able to report for duty under all circumstances, e.g., inclement weather, government closings and holidays, lapse in appropriations, non-emergency and emergency situations for operation 24 hours a day and 365 days per year coverage.
- A one-year probationary period may be required upon selection/placement.
- PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should also apply online to this announcement in order to receive consideration.
- We may make additional selections for similar positions across the entire Department of Health and Human Services (HHS) within the local commuting area(s) identified in this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s) at HHS. There is no option to opt-out as your information will not be shared with other hiring agencies outside of HHS.
- The National Institutes of Health 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.
- The NIH maintains a tobacco free work environment and campus.
You will be evaluated for this job based on how well you meet the qualifications above.
The position(s) advertised in this announcement are covered by a direct hire authority. Traditional rating and ranking of applicants, including category rating, does not apply to this vacancy. You will be initially evaluated against the basic qualifications only. Qualified applicants will be referred for consideration in accordance with the Office of Personnel Management direct hire guidelines. Veterans' Preference does not apply to positions covered by a direct hire authority.
To determine your qualifications and referral status, a review of your resume and supporting documentation may be made and compared against your responses to the vacancy questionnaire. Because your rating is based on both your responses to the questionnaire and documentation you submit, please make sure that your self-ratings are supported by the information you provide in your application. Your qualifications and self-ratings may be verified at any time during the application and selection process through quality review, interview questions, work samples, demonstrations, reference checks, and any other means. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts on the assessment questionnaire or in any other materials you submit in support of your candidacy (including but not limited to the application), or in any oral statements you may make during the selection process shall be sufficient cause to end further consideration of your candidacy. Persons listed as having knowledge of your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin prior to receiving an offer.
To be considered well qualified for the purposes of the Career Transition Assistance Program (CTAP) and the Interagency Career Transition Assistance Program (ICTAP), you must demonstrate that you substantively exceed the basic qualifications and meet all eligibility, physical, medical, suitability, and all other requirements.