Clinical Laboratory Scientist
: Job Details :

SummaryThis position is located in the Food and Drug Administration (FDA), Center of Biologics Evaluation and Research Center (CBER), Office of Blood Research and Review (OBRR), Division of Blood Components and Devices (DBCD), Blood and Plasma Branch (BPB) which has the responsibility for the review of blood establishment-related biologics license applications, supplements, amendments, registrations and inspections.This job is open to

• Federal employees - Competitive serviceCurrent or former competitive service federal employees.
• Federal employees - Excepted serviceCurrent excepted service federal employees.
• Career transition (CTAP, ICTAP, RPL)Federal employees who meet the definition of a surplus or displaced employee.
• Veterans
• Individuals with disabilities
• Military spouses
• Special authoritiesIndividuals eligible under a special authority not listed above, but defined in the federal hiring regulations.
• Peace Corps & AmeriCorps Vista
• Land and base managementCertain current or former term or temporary federal employees of a land or base management agency.

Clarification from the agencyCurrent and former permanent competitive service Federal employees; excepted service, Federal reinstatement eligibility; Previous career/career-conditional appointments; displaced Federal employees under the Career Transition Assistance Plan (CTAP) and the Interagency Career Transition Assistance Plan (ICTAP); VEOA who are veteran preference eligible separated under honorable conditions after 3 years or more; Military Spouses; PHS Commissioned Corps Officers; and individuals with disabilities.Duties

• Establishes related biologics license applications, supplements, amendments, registrations and inspections associated with manufacturers of biological products.
• Reviews and conduct regulatory and science-based reviews of applications.
• Evaluates the specific data and procedures in Biologic License Applications (BLA) supplements related to manufacture of human blood, blood components, and blood products.
• Provides guidance and instructions on establishment registration and blood product listing for manufacturers of human blood and blood products and licensed devices; responds to questions from industry on regulatory technical issues.
• Resolves industry stakeholder inquiries and issues in coordination with Agency staff.
• Writes and evaluates guidelines concerning the data required in submissions to the Agency for licensure for blood components for transfusion or for further manufacturing use into derivative products.
• Prepares summaries of the safety and effectiveness of a device submitted in a Premarket Approval application (PMA) for distribution to panel members prior to presentations.
• Assists in the preparation of panel meeting summary minutes; assures key technical issues discussed are reported clearly and accurately.

Requirements Conditions of Employment

• Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
• Selective Service Registration: All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Visit www.SSS.gov for more info.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
• Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.
• You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities.

QualificationsThe position of Clinical Laboratory Scientist falls under the 0644 occupational series. To qualify for this position at grade GS-12/13, you must meet requirements by 11:59 pm EST on 01/09/2025.BASIC REQUIREMENTS:A. 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 at the time the degree was obtained- OR- B. 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 - C. 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, or Immunology 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 Medical Technologist Series 0644 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.Minimum Qualifications: Specialized experience is experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. The specialized experience must demonstrate one year of full-time work experience, or the equivalent if part-time (for example, an employee working 20 hours per week for a 12-month period should be credited with 6 months of experience.) Experience may have been obtained in either the federal service or its equivalent with state or local government, the private sector, or nongovernmental organizations.Specialized Experience for GS-12: I have one (1) year of specialized experience equivalent to at least the GS-11 grade level in the Federal Service which includes experience (1) Ability to apply policies, procedures, and regulations to a wide range of regulatory submissions; OR (2) develops policies on blood product standards and conducts pre-license or pre-approval surveillance inspections of blood establishments; OR (3) review operating procedures and data related to collection and processing of Whole Blood and blood components, including Source Plasma, for transfusion and/or further manufacturing use.Specialized Experience for GS-13: I have one (1) year of specialized experience equivalent to at least the GS-12 grade level in the Federal Service which includes experience (1) Interpreting and applying policies, procedures, and regulations governing the regulatory activities of the office to a wide range of submission types such as Biologic License Applications (BLA), Medical Device submissions, and New Drug Applications; OR (2) Conducts research on new scientific tools and procedures to enhance knowledge of blood borne diseases and blood product safety; OR (3) develops policies on blood product standards and conduct pre-license or pre-approval surveillance inspections of blood establishments and other manufacturing facilities.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.NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application.IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume.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.You must submit supporting documentation to verify your eligibility to apply for this vacancy. For most applicants, an SF-50 will be required. However, if you are applying as a Veteran, individual with a qualifying disability, or a displaced employee, you will be required to provide other supporting documents as applicable. See the Required Documents section for details.EducationEDUCATION: THIS POSITION HAS A POSITIVE EDUCATION REQUIREMENTTRANSCRIPTS:Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.See the Application Manager Documentation for tips on submitting your paper-based documents.FOREIGN EDUCATIONApplicants using part, or all of their education completed outside of the U.S. to meet the qualification requirements, must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U.S. We will only accept the completed foreign credential evaluation.To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery. Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below:

National Association of Credential Evaluation Services (NACES)

Association of International Credentials Evaluators (AICE)

Credential evaluations are not free, and applicants are responsible for the cost of the selected service.For more information about this requirement, please visit the the If you are applying based on some other qualifying eligibility (i.e. you are not applying as a current Federal employee), you must meet the specific requirements of the eligibility you are claiming, and must have sufficient past experience to demonstrate that you are minimally qualified for this position. See Unique Hiring Paths on USAJOBS for more information about various ways you may be eligible to apply!PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.Additional informationADDITIONAL CONDITIONS OF EMPLOYMENT THAT MAY BE REQUIRED

• Pre-employment physical: NO
• Drug testing: NO
• License: NO
• Mobility agreement: NO
• Immunization: NO
• Bargaining Unit: YES, 3591
• Financial Disclosure: YES
• Ethics Pre-Clearance: NO
• Travel: 25% OR LESS
• Remote: NO
• Telework Eligible: YES, at the discretion of the supervisor.
• Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
• Special Appointing Authorities: If you are applying to this announcement based a special eligibility, such as those for people with disabilities, veterans (or military spouses), or displaced employees under a career transition program, please pay careful attention to the Required Documents section for details on application requirements for each eligibility path, to include supporting document requirements.
• All requirements must be met by the closing date of this announcement (01/09/2025 ); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.

This position will require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: All requirements must be met by the closing date of this announcement (01/09/2025). You must continue to meet all requirements throughout the entire hiring process.

• BenefitsA career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.

How You Will Be EvaluatedYou will be evaluated for this job based on how well you meet the qualifications above.Once the job opportunity announcement closes (at 11:59 pm EST on01/09/2025 ), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether you are qualified for this particular position.If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration. These assessment methods/tools may also be listed under Key Requirements.If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible, or your score may be adjusted to more accurately reflect your skills and abilities. Additionally, we will review your supporting documents and resume to determine if you are in the Area of Consideration for this vacancy. Government-Wide Merit Promotion vacancies may only accept applications from a limited audience, pay careful attention to the Who May Apply and the Hiring Paths information.Please follow all instructions carefully. Errors or omissions may affect your eligibility.Basis of Rating: Basis of Rating: Best qualified competitive merit promotion candidates and all qualified noncompetitive candidates will be referred to the hiring manager for consideration.Interagency / Career Transition Assistance Program (I/CTAP):Well-Qualified is defined as an applicant who meets the qualification standards and eligibility requirements for the position, including minimum educational and experience requirements; any qualifications and suitability; is able to perform the essential duties of the position, with or without reasonable accommodation; meets any applicable selective placement factors for the position (such as the ability to speak a specific language or any other factor required immediately upon hire); and is able to satisfactorily perform the duties of the position upon entry. To be well-qualified and exercise selection priority for this vacancy, surplus or displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position. Learn more on the Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of these competencies.

Technical Competence

Written Communication

Oral Communication

To preview the application questionnaire, click the link below

• BenefitsA career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
• Required DocumentsAs a new or existing federal employee, you and your family may have access to a range of benefits. Your benefits depend on the type of position you have - whether you're a permanent, part-time, temporary or an intermittent employee. You may be eligible for the following benefits, however, check with your agency to make sure you're eligible under their policies.Resume: At a minimum, your resume should list the position title, employer name, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position listed. A CV (curriculum vitae) may not contain enough information to meet these requirements.
  • Resume Writing Tutorial
  • Resume Writing FAQ
  Transcripts & Professional Licensure: If applicable see the Qualifications and Education Requirements section Performance Appraisal: A performance appraisal must be provided if you wish to be considered as a:
  • Current/Former land management agency employee eligible under the Land Management Workforce Flexibility Act.
  • Family member formerly serving overseas eligible under Executive Order 12721.
  Current and Former Federal Employees:To verify your eligibility and status, you must submit your most recent SF-50 showing you are/were in the competitive service and the highest grade or promotion potential held. The SF-50 must also show:
• Full position title;
• Pay Plan, Series, Grade, & Step;
• Position Occupied;
• Tenure code; and
• Service Computation Date (SCD).
If you are applying for a higher grade, the SF-50 provided must also demonstrate you meet time-in-grade. NOTE: Annual/Gen pay adjustment and award SF-50s normally do not show time-in-grade is met. Multiple SF-50s may need to be submitted to show all the required information. Learn more on the USAJOBS SF-50 Help Page.I/CTAP:If you are a current/former Federal employee who is surplus or displaced, please submit supporting documentation (e.g., a Certification of Expected Separation, separation notice, RIF separation notice, notice of proposed removal, SF-50 for RIF separation, etc.) and your most recent performance appraisal. To be selected under I/CTAP, you must be found well-qualified for this position and have a current performance appraisal rating of at least Fully Successful . See the How You Will Be Evaluated section for the agency's definition of well-qualified. Learn more on the USAJOBS Career Transition Assistance Site.Schedule A (individuals with disabilities):Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities, may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required.Military spouses eligible for a noncompetitive appointment: Documentation verifying marriage (e.g., marriage certificate) and as applicable, copy of the service member's DD-214 or Statement of Service; copy of the service member's VA disability letter; statement certifying you are the un-remarried widow or widower of the service member; and documentation of the service member's death while on active duty (e.g., DD-1300).Special appointing authority for veterans and Veterans' Preference.Veterans must submit a DD-214 (Certificate of Release or Discharge) that has the dates of service and discharge status and VA disability letter (if applicable) as proof of eligibility under a special appointing authority for veterans (e.g., VEOA, etc.) and proof for veterans' preference.
• Active Duty Members: To claim status under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011, submit written documentation from the armed forces that certifies the service member is 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.
• Parents of Deceased or Disabled Veterans: To claim preference, you must submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted.
• Widow or Widower: To claim preference, you must submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted.
• Spouse of a Living Veteran: To claim preference, you must submit a copy of the veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference, and Documentation of Veteran's Inability to Work Because of a Service-Connected Disability. Please follow the instructions in the SF-15 on required documentation to be submitted.
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.
• How to ApplyTo apply for positions with the Food & Drug Administration, you must log into account, and be signed in to that account, before you click Apply Online . See the USAJOBS Help Site article How does the application process work? for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 01/09/2025 We recommend that you start the application process early enough that you can complete and submit your application before this deadline.Please note that you cannot submit documentation or make changes to your application after the close date.If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: FDA's Applicant Help Desk is not able to support USAJOBS-related issues.The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or encounter any difficulty with the site, we recommend that you review the Applicant HELP Site at: This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you!You are encouraged to apply onl