The Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality (OCBQ), Division of Biological Standards and Quality Control (DBSQC) is recruiting to fill a Staff Fellow position in the Lab of Analytical Chemistry & Blood Related Products. The selected candidate will:
• Perform quality control tests in compliance with the quality system requirements of ISO 17025 to facilitate lot release of approved blood related products, vaccines and related products;
• Apply scientific knowledge and experience to conduct review of analytical methods and their validations for the tests submitted as part of a new BLA or supplements;
• Review and process routine summary lot-release protocols from manufacturers;
• Participate in transfer of the methods from manufacturers and other Divisions to DBSQC;
• Author new SOPs or refine existing SOPs for test methods based on scientific data and in compliance with ISO 17025 quality system and FDA requirements; and
• Other duties as assigned.
This position will be filled through the Service Fellowship program. May be up to four years in duration, with potential for renewal (not to exceed 7 years). No previous Federal experience required. Does not confer any entitlement to a position in the competitive service, and no entitlement to Merit Systems Protection Board (MSPB) appeals rights. U.S. citizenship and official transcripts are required.
QUALIFICATIONS: Ph.D. in a physical or biological science. (NOTE: Applicants must also demonstrate that they meet the minimum requirements for the occupational series for which they are being considered.) Candidates should have the ability to carry out the duties with minimum supervisory oversight, ability to work collaboratively in a team environment, and have good oral and written communication skills. Successful candidates must demonstrate at least one year of hands-on experience in HPLC analysis of proteins and AA analysis of metal ions in biological products. Experience in HPAEC-PAD analysis of oligo- and polysaccharides and Mass Spectrometry in protein analysis is preferred, but not required.
SALARY: Salary is commensurate with education and experience, with an excellent benefits package.
LOCATION: Silver Spring, MD
HOW TO APPLY: Submit electronic resume or curriculum vitae, bibliography, brief summary of research accomplishments, and names/contact information for three references to CBER Recruitment at CBER.Employment@fda.hhs.gov. Applications and all supporting documentation will be accepted through January 15, 2018. Please reference Job Code: OCBQ-18-0001-CCP.
NOTE: Please be advised that this position may be subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for me, my spouse, and my minor children. I will be required to file a Confidential Financial Disclosure Report (OGE 450) and may be required to obtain clearance from the FDA Division of Ethics and Integrity before a final offer can be made. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office website at http://www.fda.gov/AboutFDA/WorkingatFDA/Ethics/default.htm.
Link to full description and application on Shimadzu site
Position Summary: The individual in this position is responsible for a wide variety of GCMS support related functions including, but not limited to, development of technical documents related to marketing, sales, application use, training, repair, maintenance, installation, and phone support of Shimadzu GCMS product line. Travel and customer contact to support assigned product may be required. Additional responsibilities include training customers and SSI staff, as well as, other related duties that may be assigned from time to time.
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