Duties

Summary

and (8) provides transfusion medicine and cell therapy a medical consultant services.

This position is located in Cell Therapy Manufacturing and is responsible for manufacturing cell and gene therapies under INDs to support phase I and II clinical trials at the NIH Clinical Center; processing hematopoietic stem cell grafts to support NIH clinical center transplant teams; and assisting intramural investigators in obtaining cell and gene therapies manufactured at other facilities.
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Responsibilities

The purpose of this position is to serve as the Chief of the Cell Therapy Manufacturing Section which is a dynamic and expanding organization that operates more than one facility that operates twenty-four hour services.

As the Chief of the Section, the incumbent performs the following management and specialized technical duties and responsibilities:

• Setting Section goals, objectives and priorities to achieve and further the strategic direction for the CCE and developing plans to implement these;
• Ensuring that Section activities are consistent with current standards of practice and regulations;
• Evaluating staff and organizational effectiveness in accomplishing assigned goals and tasks, and trouble-shooting problems that arise in accomplishing the goals and objectives of the CCE and the Section;
• Developing and implementing more efficient and streamlined Section methods and procedures for the Section to accomplish the goals and objectives of the CCE;
• Overseeing Section quality improvement related activities to promote safe and efficient Section services;
• Establishing Section priorities, analyzing issues and making decisions based on supportable data and judgement;
• Developing, and implementing budget strategies to support the CCE expectations; and developing, implementing and evaluating cost saving initiatives;
• Managing resources allocated to the Section including identifying and justifying needs for additional resources or redeploying resources in new ways to meet the needs of the Section and the initiatives of the CCE;
• Reviewing and approving plans developed by subordinate supervisors for workforce supervision and development to assure the availability of an engaged, highly specialized and high performing staff;
• Ensuring that subordinate supervisors are properly trained and execute their human resource management responsibilities in accordance with NIH, HHS, EEOC and OPM policies and regulations;
• Furthering the goals of equal employment opportunity (EEO), taking steps to ensure the accomplishment of agency affirmative action objectives and adhering to non-discriminatory employee participation in regard to race, color, religion, gender, national origin, age, sexual orientation, or disability.
• Managing the administrative matters of the Section including contracting, procurement, space, property management, safety, and inventory control;

Travel Required

Not required

Supervisory status
Yes

Promotion Potential
14

Requirements

Conditions of Employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Position is subject to a background investigation.
• A pre-employment physical is required.
• Males born after December 31, 1959 must be registered with the Selective Service.
• Applicants must meet all qualifications requirements within thirty (30) calendar days of the closing date of this announcement.
• Position requires Education.
• This position is emergency essential.
• Work shifts may include Nights, Rotational Shifts, Holidays, On-call or Call back, and Weekends.

Qualifications

Minimum Education Requirements:
Bachelor's or graduate/higher level degree from a regionally accredited college/university including courses in biological science, chemistry and mathematics, AND successful completion of a Medical Laboratory Scientist/Clinical Laboratory Scientist program accredited by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) or an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.
OR
A full 4-year course of study that included 12 months in a college or hospital-based medical technology program or medical technology school approved by a recognized accrediting organization. The professional medical technology curriculum may have consisted of a 1-year post bachelor's certificate program or the last 1 or 2 years of a 4-year program of study culminating in a bachelor's in medical technology.
OR
A Bachelor's or graduate/higher level degree from an accredited college/university, including 16 semester hours (24 quarter hours) of biological science (with one semester in microbiology), 16 semester hours (24 quarter hours) of chemistry (with one semester in organic or biochemistry), one semester (one quarter) of mathematics, AND five years of full time acceptable clinical laboratory experience in Blood Banking, Chemistry, Hematology, microbiology, Immunology and Urinalysis/Body Fluids. This combination of education and experience must have provided knowledge of the theories, principles, and practices of medical technology equivalent to that provided by the full 4-year course of study described in A or B above. All science and mathematics courses must have been acceptable for credit toward meeting the requirements for a science major at an accredited college or university. Acceptable experience is responsible professional or technician experience in a hospital laboratory, health agency, industrial medical laboratory, or pharmaceutical house; or teaching, test development, or medical research program experience that provided an understanding of the methods and techniques applied in performing professional clinical laboratory work. Certification/licensure as a medical technologist (generalist) obtained through written examination by a nationally recognized credentialing agency or State licensing body is a good indication that the quality of experience is acceptable.
AND

Qualifications Requirement:
You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-13 level in the Federal Government. Examples of specialized experience include the following types of tasks; managing the technical and administrative operations of a laboratory engaged in manufacturing cell or gene therapies; developing policy guidance and procedural materials for laboratory personnel; overseeing a quality assurance program to ensure safety and optimal laboratory services as they relate to the manufacturing of cell or gene therapies; performing administrative work in areas such as budget and financial management, procurement and contracting, personnel management, space, safety and inventory control; and serving as a technical authority providing advice and guidance to clinicians and researchers regarding cell or gene therapy manufacturing.

Do not copy and paste the duties, specialized experience, or occupational assessment questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position.

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/10531484

Education

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 .

Additional information

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 .
If selected, you must pass a pre-employment medical examination.
This position requires weekend hours, night shifts, regular or rotational shifts, holiday hours.
This position has on-call or call-back requirements.
A one-year supervisory trial/probationary period may be required upon selection/ placement.
This position is designated as an " emergency essential " position and the selected candidate will be considered an " emergency essential " 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, lapses 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 within the commuting area(s) of the locations listed through this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s).
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.

How You Will Be Evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

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 substantively exceed the basic qualifications by scoring at least an 85 on the assessment and meet all eligibility, physical, medical, suitability, and all other requirements.

Background checks and security clearance

Security clearance
Other

Drug test required
No

Position sensitivity and risk
Non-sensitive (NS)/Low Risk

Trust determination process
Suitability/Fitness

Required Documents

RESUME:

Your resume must thoroughly describe how your skills and experiences align to the criteria defined in the "Qualifications" section of this announcement and it must support your responses to the assessment questionnaire. We cannot assume you have performed the necessary experience required for this position regardless of your employment history or academic career. To ensure all of the essential information is in your resume, we encourage you to use the USAJOBS online Resume Builder . If you choose to use your own resume, you must ensure it contains all of the required information and you organize it so we can associate the following information for each experience/position:

Job title

Name of employer

Beginning and ending dates of employment (month/day/year format)

Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.

Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory/managerial responsibilities and number of staff supervised (if applicable)

Series and grade or equivalent (if a federal position)

If the position has an education requirement or you are qualifying on the basis of education, you need to list your education history including the type of degree and your major of study. If the position requires a certain number of credit hours, you are strongly encouraged to list the relevant courses in your resume.Do not include a photograph or video of yourself, or any sensitive information (age, date of birth, marital status, protected health information, religious affiliation, social security number, etc.) on your resume or cover letter. We will not access web pages linked on your resume or cover letter to determine your qualifications.

For resume writing guidance, please visit the following resources: NIH Jobs website , USAJOBS Resource Center , and the USAJOBS Resume Writing Video Tutorial .

Assessment Questionnaire:

You must submit a completed assessment questionnaire.

Eligibility Documentation:

To be considered eligible, you must submit the following documentation, if applicable to you AND respond accordingly to the associated question on the online questionnaire. If you do not provide the required information, we will assume you are not eligible or you do not wish to be considered for any preference or eligibility.

• - SF-50 - A copy of your most recent competitive career or career conditional SF-50 that shows the effective date of your latest position and the full performance level. You may obtain a copy of your SF-50 from your human resources office or, if you are an HHS employee, from your eOPF . If you separated from Federal Government employment, you may obtain a copy of your SF-50 via the Federal Records Center, National Archives and Records Administration .
• - Veteran Documentation for eligibility purposes only: (DD-214, VA Disability Letter, etc.). Reference Standard Form 15 (SF-15) for required documentation if you are a 10-point preference eligible. Submission of SF-15 is not required, unless you have derived preference (XP) as described in questions 7, 8, or 9 on the SF-15. In those cases, you must submit a completed SF-15 and the required documentation. For 5 point preference eligibles, you must submit your DD-214 (if separated) or any written documentation from the armed forces that certifies you are expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
• - Schedule A (Disability Appointment) : Documentation of eligibility for employment under Schedule A can be obtained from a licensed medical professional (e.g., a physician or other medical professional certified by a state, the District of Columbia, or a U.S. territory to practice medicine); a licensed vocational rehabilitation specialist (i.e., state or private); or any Federal agency, state agency, or agency of the District of Columbia or a U.S. territory that issues or provides disability benefits. The letter must be printed on a medical professional's letterhead and signed. Please note the Schedule A hiring authority neither guarantees employment, nor gives an individual preference in the hiring process.
• - Documentation to support any other noncompetitive or OPM interchange agreement eligibility. Reference the Eligibility section of the questionnaire for required documents and information.
• - Visit our sites on Career Transition Assistance Program (CTAP) / Interagency Career Transition Assistance Program (ICTAP) for more information and required documentation .

Please do not submit any other supplementary documentation that is not requested of you. To protect your personal information, we will only send your resume and cover letter to the selecting official or hiring manager.