Full-Time BARDA Senior Quality Affairs SME
BryceTech is hiring a remote Full-Time BARDA Senior Quality Affairs SME. The career level for this job opening is Experienced and is accepting Washington, DC based applicants remotely. Read complete job description before applying.
BryceTech
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Background: In 2006, BARDA was established to support vaccine, therapeutic, diagnostic, and technology development during public health emergencies. BARDA's success includes 60+ FDA approvals, 101 COVID-19 products, and 136 partnerships.
General SME Responsibilities: Support BARDA in chemical, radiological/nuclear, burn/blast, and biological threat areas (viral, bacterial, influenza, emerging infectious diseases). Support research, development, manufacturing, and regulatory approval of medical countermeasures (diagnostics, medical devices, vaccines, therapeutics).
Desired Experience: Medicinal chemistry, preclinical development (animal models, pharmacology, toxicology), advanced clinical development (medical officers, immunologists, clinical operations), analytical product testing, quality control, clinical/regulatory policy, manufacturing (chemistry, manufacturing, and controls), process development, device development, reliability engineering, software, assay chemistry, microbiology, virology, immunology, plastic consumable design, manufacturing scalability, sterile manufacturing, sterile gowning. Provide guidance, recommendations, and serve on TEPs and PCTs.
Specific Responsibilities (BARDA Senior Quality Affairs Subject Matter Expert):
- Provide subject matter expertise in quality assurance and control regulations (GXPs).
- Advise BARDA senior leadership on quality issues.
- Provide training to BARDA staff on regulations, compliance, and interactions with contract facilities.
Requirements: Minimum 15 years of relevant experience in senior quality assurance/control positions in the pharmaceutical industry. Scientific degree in biology, chemistry, or pharmacy.
Deliverables: Work products related to current good manufacturing practices, good clinical practices, quality system regulations, strategic planning, and guidance for advanced development and acquisition contracts.
Benefits: Competitive salary, comprehensive health plan, company-paid insurance, 401(k), educational reimbursement.