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  1. Center for Biologics Evaluation and Research (CBER)

Staff Fellows - Chemistry Manufacturing and Controls (CMC) Review Scientists

OFFICE OF PLASMA PROTEIN THERAPEUTICS (OPPT)
OFFICE OF THERAPEUTIC PRODUCTS (OTP)
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
FOOD AND DRUG ADMINISTRATION (FDA)
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP), Office of Plasma Protein Therapeutics (OPPT) is recruiting Chemistry, Manufacturing, and Controls (CMC) Review Scientists as Staff Fellows.

We encourage outstanding scientists and biomedical engineers with training and/or experience in Biochemistry, Immunology/Immunotherapy, Molecular Biology, Cell Biology, Virology, Pharmacology/Toxicology and/or Chemistry to apply!

The mission of the Office of Therapeutic Products (OTP) is to promote public health through a data-driven process to provide regulatory oversight that helps ensure medical products are safe and effective. OTP oversees the development and regulation of a wide variety of biological products, including cell therapy products, tissue-engineered products, and gene therapy products, plasma protein products derived from blood and their recombinant analogues, and certain medical devices used in the production of these products. In addition to performing regulatory review of product quality, safety and effectiveness, OTP conducts applied scientific research related to the products that it regulates, develops relevant regulatory policies, and supports other agencies and center components involved in ensuring compliance with CBER biologics regulations.

The Office of Plasma Protein Therapeutics is strongly committed to bringing scientists, patient advocates, and the public together in partnership to develop novel advanced therapies, while protecting human subjects and ensuring product safety and quality.

The selected candidate will join a top group of scientists in a fast-paced scientific and regulatory environment. The candidate will work within a multidisciplinary team of scientists, clinicians, and biostatisticians to perform assessments of cutting-edge scientific and regulatory information for hemostasis products, including plasma-derived proteins and their recombinant analogues, submitted by small and large biotech companies, top academics, as well as large pharmaceutical companies. The candidate may also have opportunities to contribute to FDA policy and guidance development activities in a wide range of areas relevant to the regulation of biologics.

RESPONSIBILITIES:  As a Staff Fellow (CMC Research/Review Scientist), the candidate will perform the following major duties:

  • Participate as a research scientist in a program examining product safety issues and development of novel therapeutics derived from plasma proteins or recombinant or engineered plasma protein analogues. Areas of study may include the use of immunoglobulins (IGs) in specific patient populations such as pregnant women and neonates, studies towards enhanced safety and improved manufacturing of IGs and related products such as antivenoms and replacement enzymes, and development of novel therapeutic products for a broad range of indications including RSV, COVID-19, and other emerging pathogens including counterterrorism products. Information from these studies will be used to enhance understanding of factors that influence the quality, safety and effectiveness of plasma protein therapeutic products. 
  • Serves as a primary CMC reviewer for regulatory submissions on a multidisciplinary team.
  • Evaluates CMC data during premarket review of investigational products.
  • Provides science-based written and verbal feedback to sponsors regarding the design of manufacturing processes and various aspects of product characterization and quality prior to investigational new drug (IND) submissions.
  • Reviews CMC information in IND submissions to determine if product quality is defined adequately, as well as that ability to produce a product of sufficient quality for use in proposed clinical trials.
  • Evaluates the CMC sections of Biologics License Applications (BLAs) for FDA marketing approval of therapeutic products.
  • Represents FDA at various scientific and regulatory meetings, as applicable.
  • Assists in laboratory management functions, including purchasing and supply management.

BASIC QUALIFICATIONS: This position is multidisciplinary, and applicants will be required to meet the specific qualification requirements of the applicable occupational series below. Occupational Series which may be considered include General Natural Resources Management and Biological Sciences (RG-0401), Pharmacology (RG-0405), Biomedical Engineering (RG-0858) and Chemistry (RG-1320).

ADDITIONAL QUALIFICATIONS: Ph.D. or equivalent doctoral degree (M.D., D.O., D.V.M., or Sc.D., etc.) is required. Candidates are expected to be proficient in applying relevant scientific knowledge and research experience to support multi-disciplinary scientific and review of regulatory submissions.

PREFERRED SPECIALIZED EXPERIENCE: Experience with research projects related to study of immunoglobulins and related plasma protein products is highly desirable. Experience with biologics manufacturing under cGMP, as well as CMC regulatory experience is a plus, but is not required for consideration. Scientists who have experience with molecular biological techniques, protein expression, cell culture, evaluation of animal models, virology, or design and use of microphysiologic systems or 3-dimensional tissue culture methods is also desirable. In addition, the candidate must have strong collaborative skills, excellent written and oral communication skills. Postdoctoral experience is highly preferred.

FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation.

SALARY: Salary is commensurate with education and experience, including an excellent benefits package.

LOCATION: FDA White Oak Campus in Silver Spring, MD; alternate worksites may be possible.

CONDITIONS OF EMPLOYMENT: This position will be filled through the FDA’s Staff Fellowship Program, with an initial appointment period followed by opportunities for renewal. Applicants must be a U.S. citizen or lawful permanent resident.  No previous Federal experience is required. Appointment does not confer any entitlement to a position in the competitive service, and during the initial appointment there is no entitlement to Merit Systems Protection Board (MSPB) appeals rights.

  • One-year probationary period may be required.
  • Official Transcripts for all college and graduate school education required.
  • Background and/or Security investigation required.
  • If applicant is an U.S. Citizen, males born on, or after, December 31st, 1959, must be registered with the Selective Service System or have an approved exemption. Visit the Selective Service System for more info.
  • Prohibited financial interest restrictions may apply. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office webpage.
  • Lawful permanent residents are required to have resided in the United States for a minimum of three of the last five years.

HOW TO APPLY: Please submit your Federal Resume* with a cover letter containing a brief summary of your scientific accomplishments to Mr. Trevor Pendley, Program Analyst, Office of Plasma Protein Therapeutics, at trevor.pendley@fda.hhs.gov. Full applications with all supporting documents (i.e., transcripts, names/contact information for three references, proof of U.S. citizenship or lawful permanent residency status, and other supporting documentation) should be submitted by March 31, 2024. Applications will be reviewed on a rolling basis. Please reference Job Code: OTP-23-22-CJP.

*For more information on what to include in your Federal Resume, please click on the following USAjobs.gov link: https://www.usajobs.gov/help/faq/application/documents/resume/what-to-include/

ADDITIONAL INFORMATION: For additional information on CBER Careers, please visit:

HHS/FDA is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

 

 
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