Duties

Summary

DTM collects and manufactures the majority of blood components transfused in the Clinical Center. In addition, DTM collects, processes, and stores a wide range of cellular therapy products under IND for Phase I/II clinical trials. DTM has three clinical laboratories that manage blood donor testing and patient diagnostic testing: the Transfusion Service and Immunohematology Reference Laboratory, the HLA Laboratory, and the Transfusion Transmitted Viruses Laboratory. It also has the CCE.
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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.
If selected for this position, duties will include:

• 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;
• Ensuring that the cell processing goals of intramural clinical investigators are met;
• 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;
• Develop and maintain measure of CTM activity;
• Supporting the development and maintenance of information technology systems;
• Supporting the transfer of new cell therapies from the NPM section to CTM;
• 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;
• Developing, evaluating, and adjusting organizational structures and management systems for the cell engineering products and services managed;
• 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.

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 for this position.
• Position requires Education.
• This position is Emergency Essential.
• Applicants must meet all qualification requirements by the closing date of this announcement.
• Males born after December 31, 1959 must be registered with the Selective Service.
• This position may require shift work to include Nights, Rotational Shifts, Holidays, On-call or Call-Back and Weekends.

Qualifications

Basic Qualifications:
Successful completion of a full 4-year course of study in an accredited college or university, leading to a bachelor's or higher degree, with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position.

Additional Qualification Requirements:
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. performing the following types of tasks: managing the technical and administrative operations of a laboratory engaged in manufacturing cell and/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 and/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 and/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; 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/10599482

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 .

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 supervisory trial/probationary period may be required upon selection/ placement.
This position requires weekend hours, night shifts, regular or rotational shifts, holiday hours.
A newly appointed or reappointed employee may receive service credit for prior work experience or active duty uniformed service that otherwise would not be creditable for the purpose of determining his or her annual leave accrual rate. All creditable service must be directly related to the duties of the position being filled and decisions to allow for such credit must be finalized prior to the selectee's entrance on duty. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
A newly appointed or reappointed individual may receive a recruitment incentive. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
A current federal government employee may receive a relocation incentive if moving from a different geographic location. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.
If selected, you must pass a pre-employment medical examination.
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.

If you meet the minimum qualifications for this position, your application and responses to the online questionnaire will be evaluated under Category Rating and selection procedures for placement in one of the following categories:

• Best Qualified - for those who are superior in the evaluation criteria
• Well Qualified - for those who excel in the evaluation criteria
• Qualified - for those who only meet the minimum qualification requirements

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. Applicants determined to be Best Qualified will be referred for further consideration. Preference eligibles in the Best Qualified category are referred before all other applicants.

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
Credentialing , Suitability/Fitness

Required Documents

REQUIRED FOR ALL APPLICANTS

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:
1. Job title
2. Name of employer
3. Beginning and ending dates of employment (month/day/year format)
4. Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.
5. Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory/managerial responsibilities and number of staff supervised (if applicable)
6. 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 must 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 Cente r, and the USAJOBS Resume Writing Video Tutorial.

ASSESSMENT QUESTIONNAIRE:

You must submit a completed assessment questionnaire.

All the above information is necessary to determine your qualifications for the position. Not providing the required information may result in a determination that you do not meet minimum requirements for the position (e.g., an ineligible rating) or a lower rating.

REQUIRED DOCUMENTATION FOR PREFERENCE OR ELIGIBILITY CLAIMS

To claim veterans' preference, career transition selection priority, Schedule A eligibility or military spouse, you must provide the documentation listed below AND respond accordingly to the associated question on the online questionnaire.

• Veterans' preference (DD-214, VA Disability Letter, etc.): Reference Standard Form 15 (SF-15) for required documentation for 10 point claims. Submission of SF-15 is not required, unless you are claiming 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 claims, 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.
• Visit our sites on Career Transition Assistance Program (CTAP)/Interagency / Career Transition Assistance Program (ICTAP) for more information and required documentation.
• Visit our site on the Appointment of Certain Military Spouses for more information and required documentation to verify eligibility.

Schedule A Eligibility (Applicants with Disabilities)

Applicants who are eligible to be considered under Schedule A must submit appropriate documentation to verify eligibility. Documentation must 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. The Schedule A and military spouse hiring authorities do not guarantee employment or, you do not wish to be considered for any preference or eligibility.

If you do not provide the required information, we will assume you are not eligible or you do not eligible for any preference or eligibility.

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.

If you are relying on your education to meet qualification requirements:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education .

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.