Full-Time BARDA Senior Drug/Vaccine/ Diagnostic/Clinical Development SME

Background. In 2006, the Biomedical Advanced Research and Development Authority (BARDA) was established to support vaccine, therapeutic, diagnostic, and innovative technology development for public health emergencies. BARDA's success is evident in 60+ FDA approvals, licenses, and clearances, 101 biomedical products supported for COVID-19 response, and 136 partnerships. This success is driven by public-private partnerships accelerating Medical Countermeasure (MCM) development for National Security.

General SME Responsibilities. Support BARDA program offices as a subject matter expert in Chemical, Radiological/Nuclear, Burn and Blast Injuries, Biological (viral/bacterial), Influenza, and Emerging Infectious Diseases. Expertise required in research, development, manufacture, and regulatory approval/licensure/clearance of MCMs (diagnostics, medical devices, vaccines, therapeutics). Candidates with experience in medicinal chemistry, preclinical development (animal models, pharmacology, toxicology), advanced clinical development (medical officers, immunologists, clinical operations), analytical product testing, quality control, clinical/regulatory policy, and manufacturing (chemistry, manufacturing, and controls) are desired. Experience is also needed in process development, process scale-up, process optimization, device development, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology, plastic consumable design/manufacturing, manufacturing scalability, capacity expansion, sterile/aseptic techniques, sterile manufacturing/filling, sterile facilities (sterile gowning) is necessary.

Specific Responsibilities. Provide guidance and recommendations on identified issues. Serve as advisor on Technical Evaluation Panels (TEPs). Participate on Program Coordination Teams (PCTs). Provide assessments, recommendations, guidance, and educational material to PCTs and CORs. Provide subject matter expertise and advisory support to federal staff for cost estimates. Review study protocols, reports, regulatory documents, and proposals. Develop work products (expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, review, technical assessments). Advise federal staff on contractor proposed Statements of Work, improvements, risk/benefit analyses, and balanced recommendations. Participate in strategic discussions to build new program areas. Provide recommendations for project development and portfolio management.

Drug/Vaccine/Diagnostic/Clinical Development SME Specific Responsibilities. Oversee and report CMC biologics product development from pre-clinical to full-scale. Apply knowledge of bringing a lead candidate through the commercialization process. Apply experience with drug formulation and identifying/resolving quality, regulatory, process development, or manufacturing issues. Knowledge of cleaning validation, analytical/manufacturing technology transfer, and process validation is required. Knowledgeable in analytical methods used to assess drug substance and drug product quality, and specifications development. Apply experience in preparing CMC sections of INDs and BLAs, auditing biologic drug product manufacturing facilities. Prior experience in a matrix, team-oriented CMC leadership environment is essential. Liaise with service providers to monitor progress, resolve issues, review/manage technical data, and maintain a qualified service provider list.

Additional Responsibilities. Support quality systems for non-clinical safety studies and CMC activities to assure compliance with GLP, GMP, and GDP requirements. Establish and maintain working relationships with external organizations. Apply experience in managing international business relationships. (15 years biologics experience required.)

Education. Ph.D. in relevant discipline (Pharmaceutical Sciences, Biochemistry, Virology, Microbiology, Chemistry, Engineering) preferred, or B.S./M.S. with sufficient experience in biopharmaceutical product development. Ability to travel up to 10%.

Benefits. BryceTech offers competitive salary, comprehensive health/dental/vision plans, company-paid life/disability insurance, 401(k) plan, and educational reimbursement.

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