Summary Are you interested in a unique opportunity to serve as a Biologist in the world's largest hospital devoted to translational clinical research? Join the NIH Clinical Center for Cellular Engineering in Bethesda, MD, supporting cellular therapy products for clinical research. The Center for Cellular Engineering serves as a trans-NIH core facility for the manufacture of novel and standard transplant cellular therapy (CT) products in support of 50+. Phase 1/11 clinical trials and research trials. Responsibilities As a GS-0401-11 Biologist (Cell Manufacturing), your duties may include, but are not limited to the following: Performing cell processing and manufacturing activities for HCT/P and cellular therapy products in accordance with established protocols, standard operating procedures, regulatory requirements, and quality control standards. Performing laboratory testing, including cell counts, viability testing, product characterization, safety assays, and other testing needed to support donor testing, product release, and clinical use. Ensuring product identity is maintained throughout the manufacturing process, including final product labeling, and prepare all required product labels and documentation. Identifying, troubleshooting, and communicating problems related to manufacturing, sample testing, equipment, or product results, and assist with corrective actions to resolve discrepancies. Assisting with evaluating, validating, and implementing new or revised cell manufacturing processes, laboratory testing procedures, equipment, and methodologies to improve efficiency, accuracy, and quality. Requirements Conditions of Employment Qualifications In order to qualify for a Biologist (Cell Manufacturing), GS-401-11 position, you must meet the following Education Requirements: A. I have completed the requirements for a bachelor's (or graduate) degree in a biological science, agriculture, natural resource management, chemistry, or related disciplines appropriate to this position, from an accredited college or university. OR B. I have a combination of experience and education which includes courses comparable to a major in biological science, agriculture, natural resource management, chemistry or related disciplines appropriate to this position, AND I have appropriate experience or additional education which demonstrates similarly appropriate skills or abilities needed to perform the duties of this position. In addition to the above basic requirement, in order to qualify for a Biologist (Cell Manufacturing), GS-0401 position at the GS-11 level, you must have: A. 3 years of progressively higher-level graduate education leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree that is directly related to the duties of this position; OR B. 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 @types of tasks: manufacturing complex cell and gene therapies, identifying and communicating problems with sample testing, analyzing and interpreting data from preclinical manufacturing experiments. OR C. A combination of post-baccalaureate education and experience that meets 100% of the qualification requirements for this position. You will receive credit for all experience material to the position, including experience gained in religious, civic, welfare, service, and organizational activities, regardless of whether you received pay. Do not copy and paste the duties or specialized experience from this announcement into your resume, as that will not be considered a demonstration of your qualifications for this position. We may verify or assess your qualifications at any time. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts may be sufficient cause to end further consideration of your candidacy. Persons listed as knowing your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin before receiving an offer. Preview application questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12956725 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 Based on your appointment, a one or two-year trial/probationary period may be required. A decision regarding your continued employment with NIH will be made as you near the end of this period. 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. 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. 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. Must be able to perform the essential duties of the position, with or without reasonable accommodation. Visit our Help Applying page for helpful information on the application process. If selected, you may be eligible to receive a salary above the minimum based on superior qualifications and/or a special need of the Government for your services. This applies to employees paid under the General Schedule (GS) and Federal Wage System (FWS) pay systems and is at the discretion of the hiring manager. A salary above the minimum must be approved before the appointment.
