Clinical Laboratory Scientist (Cell Processing) - CC - DE
The NIH Department of Transfusion Medicine is seeking a Clinical Laboratory Scientist (Cell Processing) for the Cell Processing Section (CPS). The DTM includes an FDA-licensed blood collecting facility as well as a transfusion service, diagnostic testing laboratories and FDA-registered cell processing facilities. The CPS collects, processes, and stores a wide range of cellular therapy produced under IND for Phase I/II clinical trials. As a Clinical Laboratory Scientist (Cell Processing), your assignment will be to manufacture high-quality cellular therapy products in support of NIH clinical research programs. The products include hematopoietic stem cells for transplantation, mononuclear cells for adoptive immunotherapies, dendritic cell vaccines and genetically modified cells for treatment of immunodeficiency syndromes and cancer. Safety, purity and potency assays which include sterility testing, flow cytometric analysis, viability testing and progenitor cell assays are performed on each product. The clinical products are prepared in a cleanroom manufacturing suite using aseptic processing techniques. The ideal candidate will possess the following:Knowledge of medical technology applicable to the manufacture of cellular therapy products within a cleanroom environment and complex problems involving diverse aspects of clinical laboratory practice related to cellular therapy products such as difficulties with cell counting, viability testing and flow cytometric assays.
Ability to manage and coordinate daily work activities related to the manufacture of a clinical cellular therapy product, including the reporting of assay results and unexpected findings needed to make clinical decisions related to patient care.
Ability to work in a biologic safety cabinet using aseptic technique so that the risk of contamination of a cellular therapy product is minimal.
Ability to perform quality checks as needed and maintain detailed documentation of the status of the facility, equipment, reagents and the processing steps for clinical manufacturing.
Ability to participate in the development, qualification and implementation of new or revised processes for the manufacture or evaluation of cellular therapy products.
Skill to follow and train others on standard operating procedures for basic cell manipulations, complex cell separation techniques and ex vivo cell culture.
Skill to maintain, troubleshoot and repair laboratory instrumentation.
Relocation expenses reimbursed No
Males born after December 31, 1959 must be registered with Selective Service.
Basic Education Requirements for this position:
A 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 (external link) at the time the degree was obtained.
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.
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.
In addition to meeting the basic education requirement, in order to qualify for the GS-11 level you must possess:
Three years of progressively higher level graduate education leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree in a related field.
A combination of post baccalaureate education and experience that meets 100% of the qualification requirements for this position.
You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-09 level in the Federal service obtained in either the private or public sector performing the following tasks: manufacturing and potency testing of cellular therapy products; performing various procedures such as cellular flow cytometric analysis, cryopreservation using a controlled rate freezer, and cell separation using an automated device; ex vivo cell culture and expansion; performing quality assurance/ control procedures for cleanroom facility and equipment; and establishing and maintaining record keeping systems to track work production and activities.
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.
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 .
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.
A one-year probationary period may be required upon selection/ placement.
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 selectees entrance on duty. The use of this service credit incentive is at the discretion of the selecting official and service credit is granted only for a position deemed hard-to-fill.
Additional selections may be made through this vacancy announcement. 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.Read more
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
Candidates determined to be Best Qualified will be referred to the hiring manager for further consideration and possible interview. 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.Read more Security clearance Q - Nonsensitive