Vaccine Product and Regulatory Specialist - Malaria
GDIT is seeking a vaccine product and regulatory specialist to support WRAIR's Malaria Vaccine Research Program. The contractor shall be responsible for assisting with the management of vaccine development initiatives, including the production of vaccines for Phase 1 and 2 vaccine trials. The contractor shall coordinate the production, quality control, formulation and other components of the vaccine development process within the Malaria Vaccine Branch. The contractor shall act as the central element within the Malaria Vaccine Branch for the coordination of regulatory documentation regarding the execution of clinical vaccine trials and other human use protocols. Specifically, the contractor shall:
- implement quality control procedures for assaying purity, integrity, stability and potency of the bulk antigen and formulated products;maintain the calendar for product stability and potency to ensure FDA requirements for stability testing and potency testing are metproduce a series of laboratory protocols and SOPs for each product;conduct testing of GMP produced malaria vaccine candidates to ensure stability;review data from protocols, procedures and assays conducted by staff;prepare, with companies, appropriate toxicology study protocols;assist in acquiring and submitting all required documentation to the Institutional Review Board;prepare IND and other regulatory documents;assist in preparation of IND and other regulatory documents;advise and monitor financial aspects of clinical projects, including budget development, milestones and deliverables timeline, and financial reports;assist in writing the Cooperative Research and Development Agreement’s (CRADA) and Clinical Trial Agreement (CTA);coordinate and write reports, work plans and scopes of work for clinical projects;manage scheduling and planning of meetings, including compiling and organizing relevant background materials, preparing minutes, and monitoring follow-up activities;maintain records, including paper and electronic filesdevelop timelines for vaccine candidates through phase 2 clinical trialsprovide assistance with all job-related progress reports/technical reports; andsupport a safe workplace ensuring awareness of and observing appropriate safety and occupational health rules and regulations.
- Bachelors Degree in a related discipline, or the equivalent combination of education, professional training, or work experience.
- 5-8 years of related experience in call center monitoring, quality assurance, and/or customer service.Knowledge of regulatory procedures related to clinical trials, human and animal use protocols. Abilities relatedt to vaccine product development, GMP manufacture, QA/QC release testing and preparation and filing INDs to the FDA, and final reports