Job Announcement Description
The National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC) is recruiting for a staff scientist in the Vaccine Production Program (VPP) at the National Institutes of Health (NIH), part of the Department of Health and Human Services (DHHS).
The goal of the VPP is to efficiently translate candidate research vaccines into materials for proof-of-concept clinical trials and to enable advanced development and licensure by partners. The VPP is responsible for process design and development, clinical good manufacturing practices (cGMP) manufacturing, preclinical safety testing, and regulatory activities for all VRC products. Within the VPP, the Formulation Development Group is responsible for the development of stabilizing formulations for GMP drug substance and clinical drug products, as well as in-process intermediates, development of specific particle-based GMP release and characterization assays, and drug product process development. The Formulation Development Group supports VRC clinical trials directly via development of clinical administration procedures, verification of vaccine stability under administration conditions, and evaluation of the effect of clinical site handling and storage excursions on product quality during ongoing trials.
The successful candidate will use their training and work experience to perform highly complex vaccine and therapeutic product research and development (particularly in the area of formulation development) for clinical drug products to prevent or treat diseases such as HIV, influenza, coronavirus disease, Ebola, and malaria. The successful applicant will lead the VPP’s Formulation Development Group which is responsible for the formulation development, including characterization and manufacturability and stability assessment, of VRC drug substances and clinical drug products. The successful candidate will also serve as Subject Matter Expert on formulation development and stability for collaboratively developed and produced clinical drug products.
In addition to the above responsibilities, the staff scientist is expected to:
- Develop, improve, analyze, and troubleshoot experiments related to formulation development, such as the development of stabilizing formulations for GMP drug substance and clinical drug products and in-process intermediates, development of specific particle-based GMP release and characterization assays, and drug product process development.
- Provide supervision, mentorship, and training to the Formulation Development Group including junior and new research staff.
- Establish and participate in research and development collaborations with other NIH investigators and/or outside organizations.
- Serve as the key resource on formulation development and stability for collaboratively developed and produced clinical drug products, including clinical administration, dose preparation, formulation, stability, and handling for clinical trials.
- Maintain detailed records of experiments and prepare the information resulting from these experiments for presentations at laboratory-wide, NIH-wide, and national and international meetings as well as for publication.
- Manage a team to maintain laboratory and equipment. Ensure maintenance of laboratory supplies and equipment (including chemicals, biological materials, carcinogens, recombinant protein materials, acids, biological wastes, etc).
The candidate must have a deep knowledge of formulation development and GMP activities, coupled with extensive experience in the following:
- Phase I/II formulation development for vaccine and therapeutic antibody candidates
- Formulation development for biopharmaceuticals, including fusion protein-based nanoparticles, protein conjugate vaccines, and virus-like particles
- Process and method tech transfer activities from research and development to GMP areas
- Development of CMC information to support regulatory filings
- Formulation development for vaccine and monoclonal antibody products in disease areas (such as HIV, influenza, and Ebola)
- Chemical, biochemical, and pharmaceutical laboratory techniques for development of pharmaceutical formulations
- Related laboratory methodologies for formulation development for candidate pharmaceuticals
Finally, the candidate must have an established record of publication in peer-reviewed scientific journals.
- Doctoral degree in pharmaceutical chemistry, biochemistry, or related discipline
- At least 5 years of relevant postdoctoral experience
- At least 5 years of direct experience in formulation development for vaccines or monoclonal antibody products
- At least 4 years of experience in leading a team for biopharmaceutical formulation development for vaccines and therapeutic antibody products
- Extensive experience in handling biological samples and standard practices related to biohazardous material
- Demonstrated experience and strong knowledge biopharmaceutical formulation development for vaccines and antibody products
- Demonstrated publication record in formulation development and/or pharmaceutical chemistry
U.S. citizenship is not required.
The salary is commiserate with qualifications and experience.
Interested candidates may contact Carrie Martin via email, VRCADMIN@niaid.nih.gov, for additional information about the position. To apply for the position, candidates must submit a curriculum vitae (CV), statement of research interest, and the contact information for three referees who will be asked to provide letters of reference.
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HHS, NIH, and NIAID are equal opportunity employers.