Are you interested in a truly unique opportunity to serve as a Biologist in the world's largest hospital entirely devoted to translational clinical research? The National Institutes of Health invites candidates with strong operational, clinical research, and leadership credentials to apply for the position of Biologist (Manufacturing), Department of Transfusion Medicine and Center for Cellular Engineering at the NIH, Clinical Center, Bethesda, MD.

Duties

As a GS-0401-12 Biologist (Manufacturing), your duties may include but are not limited to the following: Leads the training of staff on the use of new instruments and equipment. Prepares new SOPs and revises existing SOPs for the manufacturing team and performs biennial SOP reviews of SOPs to ensure they reflect current practices. Performs manual cell counts and viability tests to enumerate and characterize clinical products. Participates in out-of-specification/trend, deviation, and root cause investigations to prevent further occurrences and improve the quality and safety of clinical trial products. Fully documents corrective and preventative actions and provides follow-up evaluations to establish that the measures taken are effective. Employs safe work practices and uses appropriate personal protective equipment to minimize the potential of hazard exposure or unnecessary contamination of the laboratory environment. Drafts documents for training and competency assessments of new equipment and techniques.

Requirements

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
• 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 requires Education - please submit transcripts.
• A one-year probationary period may be required upon selection/placement.
• If selected, you must pass a pre-employment medical examination.
• This position is a Tier 1 Emergency Essential position.

Qualifications

In order to qualify for a Biologist (Manufacturing), GS-0401, you must meet the following education requirements: A. Completed the requirements for a bachelor's (or graduate) degree in biological science, agriculture, natural resource management, chemistry, or related disciplines appropriate to this position, from an accredited college or university. OR B. A combination of experience and education which includes courses comparable to a major in a biological science, agriculture, natural resource management, chemistry, or related disciplines appropriate to this position, AND appropriate experience or additional education which demonstrates similarly appropriate skills or abilities needed to perform the duties of this position. In addition, in order to qualify for a Biologist (Manufacturing) position at the GS-12 level, you must: have 1 year of specialized experience equivalent to at least the GS-11 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: independently manufacturing complex and emerging cell and gene therapies involving multiple procedures including multi-stage cell enrichment and isolations, cell culture, cell transduction, peptide pulsing, and cell harvesting, and new emerging methodologies; preparing new SOPs and revising existing SOPs to ensure they reflect current manufacturing practices; performing cell processing and laboratory testing in accordance with regulatory and accrediting agency requirements including AABB Standards for Cellular Therapy Product Services; organizing and completing manual and e-records related to product manufacturing which includes documentation of equipment and all materials used; and leading the training of staff on the use of new equipment and manufacturing procedures. 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. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12131753

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.

Contacts

• Address National Institutes of Health 6701 Rockledge Dr Bethesda, MD 20892 US
• Name: NIH HR Service Desk Branch E
• Email: [email protected]