Principal Investigator – Interdisciplinary Scientist

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 Cellular and Gene Therapies (DCGT) is recruiting to fill multiple Principal Investigator positions.

The FDA White Oak Campus has state-of-the-art laboratories with high-quality core facilities that include: a vivarium supporting 12 animal species, corresponding veterinary services, and animal imaging; confocal microscopy; flow cytometry; high-performance computing; and genomics and biotechnology. For more information about OTAT research programs and investigators, please visit the Tissue & Advanced Therapies Research Webpage. Also, visit the Cellular & Gene Therapy Products Webpage for information about regulatory oversight of cellular and gene therapy products.

We are recruiting Principal Investigators in the following areas of research:

• Developmental Biology and Stem Cells
• Biomaterials
• Tissue Engineering
• Bioinformatics and Computational Biology
• Cell and Gene Therapies for Cancer

RESPONSIBILITIES: Incumbents in these positions will independently lead a research laboratory and will also review regulatory applications submitted to FDA. The successful candidate will develop and lead an independent research program relevant to classes of products that are regulated by DCGT and will perform regulatory review of applications submitted to FDA. Product classes include gene therapies, genome editing products, oncolytic viruses, therapeutic vaccines, cell therapies, xenotransplantation products, engineered tissues and certain devices. Specifically, the selected candidate will be responsible for the following duties:

• Leading a research laboratory as a Principal Investigator.
• Publishing research in peer-reviewed scientific journals.
• Presenting research within FDA and externally at national or international scientific conferences.
• Independently initiating and managing scientific collaborations.
• Training and mentoring lab staff.
• Managing a lab budget.
• 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), as applicable.
• Performing review of product manufacturing and testing information in applications submitted to the FDA. Types of submissions may include investigational new drug applications, biologics license applications, and submissions for investigation, clearance, or approval of medical devices.
• Provide authoritative written reviews of regulatory submissions while meeting all applicable deadlines.
• Provide expert advice and guidance to product manufacturers, including communicating by phone or email.
• Participate in inspections of manufacturing facilities.
• Provide technically authoritative expert advice and develop regulatory guidance and policy.

BASIC QUALIFICATIONS: This position is multidisciplinary, and applicants will be required to meet the specific qualification requirements of one 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 in Courses equivalent to a major, plus appropriate experience or additional education.

Microbiology (RG-0403): Degree in microbiology; or biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent. – OR – Combination of education and experience in courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown in A above, plus appropriate experience or additional education.

Bioengineering and Biomedical Engineering Series (RG-0858): Degree in Engineering. To be acceptable, the program must: (1) lead to a bachelor's degree in a school of engineering with at least one program accredited by ABET; or (2) include differential and integral calculus and courses (more advanced than first-year physics and chemistry) in five of the following seven areas of engineering science or physics: (a) statics, dynamics; (b) strength of materials (stress-strain relationships); (c) fluid mechanics, hydraulics; (d) thermodynamics; (e) electrical fields and circuits; (f) nature and properties of materials (relating particle and aggregate structure to properties); and (g) any other comparable area of fundamental engineering science or physics, such as optics, heat transfer, soil mechanics, or electronics. – OR – Combination of education and experience -- college-level education, training, and/or technical experience that furnished (1) a thorough knowledge of the physical and mathematical sciences underlying engineering, and (2) a good understanding, both theoretical and practical, of the engineering sciences and techniques and their applications to one of the branches of engineering. The adequacy of such background must be demonstrated by one of the following:

1. Professional registration or licensure -- Current registration as an Engineer Intern (EI), Engineer in Training (EIT), or licensure as a Professional Engineer (PE) by any State, the District of Columbia, Guam, or Puerto Rico. Absent other means of qualifying under this standard, those applicants who achieved such registration by means other than written test (e.g., State grandfather or eminence provisions) are eligible only for positions that are within or closely related to the specialty field of their registration. For example, an applicant who attains registration through a State Board's eminence provision as a manufacturing engineer typically would be rated eligible only for manufacturing engineering positions.
2. Written Test -- Evidence of having successfully passed the Fundamentals of Engineering (FE) examination or any other written test required for professional registration by an engineering licensure board in the various States, the District of Columbia, Guam, and Puerto Rico.
3. Specified academic courses -- Successful completion of at least 60 semester hours of courses in the physical, mathematical, and engineering sciences and that included the courses specified in the basic requirements under paragraph A. The courses must be fully acceptable toward meeting the requirements of an engineering program as described in paragraph A.
4. Related curriculum -- Successful completion of a curriculum leading to a bachelor's degree in an appropriate scientific field, e.g., engineering technology, physics, chemistry, architecture, computer science, mathematics, hydrology, or geology, may be accepted in lieu of a bachelor's degree in engineering, provided the applicant has had at least 1 year of professional engineering experience acquired under professional engineering supervision and guidance. Ordinarily there should be either an established plan of intensive training to develop professional engineering competence, or several years of prior professional engineering-type experience, e.g., in interdisciplinary positions. (The above examples of related curricula are not all-inclusive.)

Chemistry Series (RG-1320): Degree in physical sciences, life sciences, or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics. – OR – Combination of education and experience in course work equivalent to a major as shown in A above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience, or additional education.

ADDITIONAL QUALIFICATIONS: Ph.D. or equivalent terminal 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 2 years of post-doctoral experience in at least one of the following: Developmental Biology and Stem Cells; Biomaterials; Tissue Engineering, Bioinformatics and Computational Biology; Cell and Gene Therapies for Cancer.

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 website 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 four references to CBER Recruitment at CBER.Employment@fda.hhs.gov. In addition, include a statement of your proposed research plans and how they would be applicable to this position (maximum 2 pages). Applications and all supporting documentation will be accepted through February 17, 2023. Please reference Job Code: OTAT-23-05-SCI.