OFFICE OF TISSUES AND ADVANCED THERAPIES (OTAT)
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 Tissues and Advanced Therapies (OTAT), Division of Plasma Protein Therapies (DPPT) is recruiting to fill a position to serve as a Principal Investigator in the Plasma Derivatives Branch (PDB).
The broad research aims include study of efficacy, safety, potency or pharmacology relevant to use of modified, recombinant, or native plasma-derived proteins to prevent or treat serious conditions. PDB scientists are actively engaged in research to develop new tools including in vivo and in vitro methods to improve/predict safety or efficacy of investigational and licensed plasma derivatives.
RESPONSIBILITIES: The successful candidate will lead the development of an independent research program relevant to safety and effectiveness of plasma derivatives and their recombinant analogs. The products include polyclonal human or animal-derived antibodies, serine protease inhibitors, antitoxins and antivenoms, and analogous recombinant or modified proteins. Research may include development and use of mission-relevant predictive preclinical models particularly those related to vulnerable populations (such as pregnant, immunocompromised, or rare disease patients). Specifically, the selected candidate will be responsible for, but not limited to the following duties:
- Performing review of biological product submissions in the area of plasma proteins, particularly submissions that contain preclinical animal or in vitro data intended to demonstrate safety, efficacy or pharmacokinetics of investigational products prior to use in humans. The incumbent will also evaluate toxicology information submitted for preclinical product characterization or related to chemical impurities found in licensed or investigational products. Types of submissions include INDs, pre-INDs, and BLAs. Functioning as an authoritative and independent expert.
- Provide expert advice and guidance to sponsors, including communicating by phone or email.
- Provide technically authoritative expert advice and develop guidance and policy, especially in the area of preclinical studies.
- Maintaining compliance with all applicable safety regulations and requirements of Animal Care and Use Committee (ACUC), Institutional Review Board (IRB), and Institutional Biosafety Committee (IBC).
- Presenting research within FDA and externally at national or international scientific conferences.
- Meet all PDUFA milestones as well as internal guidelines for written review timelines.
- Independently initiating and managing scientific collaborations.
- Conducting peer-reviews of manuscript publications.
- Training and mentoring lab staff.
- Managing a lab budget.
BASIC QUALIFICATIONS: This position is multidisciplinary, and applicants will be required to meet the specific qualification requirements of the applicable occupational series below.
General Natural Resources Management and Biological Sciences (RG-0401): Degree in biological sciences, chemistry, or related disciplines appropriate to the position, – OR – Combination of education and experience: Courses equivalent to a major, plus appropriate experience or additional education.
Pharmacology (RG-0405): Degree in an appropriate biological, medical, veterinary, or physical science, or in pharmacy that included at least 30 semester hours in chemistry and physiology and 12 semester hours in pharmacology.
ADDITIONAL QUALIFICATIONS: Ph.D. or equivalent doctoral degree (M.D., D.V.M., or Sc.D. etc.) is required. Candidates must possess excellent oral and written communication skills and have an outstanding publication record. Previous experience with regulatory review is desirable but not a requirement. Also, candidates must demonstrate potential for leadership, mentoring and managing people.
REQUIRED SPECIALIZED EXPERIENCE: Candidates must have more than 5 years of post-doctoral experience in at least one of the following: immunology, research pharmacology, virology, and/or microbiology. The candidate will need working knowledge in molecular biology. Experience with animal models, cutting edge in vitro models, and specific knowledge related to immune globulin Fc domain function, maternal/fetal transmission of therapeutic products and/or immunogenicity. Experience related to post-translational changes, especially glycosylation related to immune globulins is also desirable.
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, with an excellent benefits package.
LOCATION: FDA White Oak Campus in Silver Spring, MD
CONDITIONS OF EMPLOYMENT: This position will be filled through the Service Fellowship program, with an initial appointment period followed by opportunities for renewal. Applications will be accepted from all groups of qualified candidates, including U.S. citizens or non-U.S. Citizens holding valid immigration status and work authorization at the FDA. 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 are required.
- Background and/or Security investigation is 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 www.SSS.gov 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 at FDA Ethics and Integrity Office.
- Non-US and permanent residents are required to have resided in the United States for a minimum of three of the last five years.
HOW TO APPLY: Submit electronic resume or curriculum vitae with a cover letter containing a brief summary of scientific accomplishments and the names/contact information of three references to CBER Recruitment at CBER.Employment@fda.hhs.gov. In addition, include a statement of proposed research direction and how it would be applicable to this position (maximum 500 words). Applications and all supporting documentation will be accepted through November 30, 2022. Please reference Job Code: OTAT-22-22-CJP.
ADDITIONAL INFORMATION: For additional information on CBER Careers, please visit:
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