BARDA Drug/Vaccine Supply Chain Manager Subject Matter Expert

Company Description

BryceTech has partnered with technology and R&D clients to deliver mission and business success since 2017. Bryce combines core competencies in analytics and engineering with domain expertise. Our teams help government agencies, Fortune 500 firms, and investors manage complex programs, develop IT tools, and forecast critical outcomes. We offer clients proprietary, research-based models that enable evidence-based decision-making. Bryce cultivates a culture of engagement and partnership with our clients. BryceTech is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran

Job Description

Background. In 2006 the Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. The BARDA model’s success is codified in 1) 60+ Food and Drug Administration (FDA) approvals, licenses, and clearances, 2) 101 Biomedical products supported for COVID-19 response, and 3) 136 BARDA-supported COVID-19 partnerships. This success centers on BARDA’s public-private partnerships, which have accelerated the development of Medical Counter Measures (MCM) vital to our National Security. BARDA provides its partners critical capability and technical support needed to accelerate MCM regulatory approval and deployment, including support for advanced research and development (AR&D), FDA licensure, and clinical use.  

Subject Matter Expert Responsibilities – General.

• Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics, preventives, and therapeutics.
• Provide guidance and recommendations on key issues related to the area(s) identified above.
• Review study protocols, study reports, regulatory documents, presentations, proposals, and related documents.
• Provide senior-level briefing(s) to ASPR/BARDA as required.
• Prepare regular reports to ASPR/BARDA management on various technical issues identified as required.
• Provide recommendations for project development level portfolio management and oversight as required.
• Develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts.
• Participate in Market Research efforts.

Drug/Vaccine Supply Chain Manager Subject Matter Expert Specific Responsibilities.

• Significant experience in all areas of biopharmaceutical supply chain and logistics to include warehousing, enterprise, and inventory systems, purchasing, and transportation.
• Significant experience in pharmaceutical product development and Total Life Cycle Cost (TLCC) management.
• Experience with supplier qualification, management, and customer services practices.
• Experience in pharmaceutical packaging, and distribution solutions.
• Experience with inventory tracking and systems.
• Experience with regulatory authorities.
• Translate the clinical supply requirements into an executable manufacturing, packaging, and labeling plan to ensure all clinical drug supplies are available as needed to maintain project timelines.
• Collaborate with Clinical Development and Operations, CMC, Regulatory Affairs, Quality Assurance, and Product Leadership to determine appropriate quantities, packaging configuration, labeling, blinding techniques, and optimal shipping plans.
• Manage and plan forecasts to supply/re-supply all clinical studies to support project timelines.
• Maintain CMC documentation in support of clinical trials, including but not limited to batch records, packaging records, COAs, stability tables, shipping temperature data.
• Develop and obtain required approvals for global clinical labeling activities.
• Serve as the point of contact with clinical secondary packaging and labeling vendors to coordinate labeling, packaging, shipment, and final disposition of clinical supplies, and ensure all work is completed accurately and on time.
• Resolve logistical conflicts impacting clinical studies and development milestones.
• Proactively identify and communicate study timeline or clinical supply risks, from a supply chain perspective to all key stakeholders on the project(s).

Qualifications

• Bachelors or Master’s Degree in Supply Chain Management, Management I