Pharmaceutical Manufacturing Program Analyst

BryceTech is currently looking for a Pharmaceutical Manufacturing Program Analyst. The person in this role will support a high-visibility HHS ASPR client managing over $21B in portfolio value with a variety of needs including support to the project team and domestic supply chain analysis efforts. Specifically, this person will provide analysis on the technical and programmatic progress of ongoing manufacturing scale-up efforts, and the assessment of novel approaches to domestically produced Active Pharmaceutical Ingredients (API’s), key starting materials, and excipients. This is a dynamic position for a person with attention to detail and adaptability to changes in regulatory policy, trade policy, and shifts in the global supply chain for pharmaceutical materials. Work will be performed on a hybrid schedule in Washington D.C. The person in this role will:Advise on innovative approaches for the successful development, manufacture, and distribution of drug product, APIs, excipients, and key starting materials, and/or related products.Identify and propagate QA/QC best practices with our industry partners to improve manufacturing, testing, distribution, and reporting processes.Support Engagement with manufacturers, commercial labs, upstream suppliers, and distributors, to include:Take and compile meeting notes from calls with manufacturers, commercial labs, test manufacturers, upstream suppliers, and distributors.Track communications and check-ins with manufacturers, commercial labs, test manufacturers, upstream suppliers, and distributors.Draft follow-ups for Industry Engagement Team from check-in calls.Provide technical and QA/QC review of materials before distribution and/or storage to ensure clarity and accuracy of collected and shared information.Operations Management: Provide operational and project management support for office/division/branch activities. Provide analysis of technical reports, integrated master schedules, audit findings, and financial status.Prepare and draft and final report(s), including formatting and document QA/QC for submission. Provide analysis, research, and recommendations on all quality standard operating procedures, policy, processes and procedures, and associated regulations, to assure compliance with the Quality Management System.Develop, manage, and maintain liaison relationships with other HHS Offices and Operating Divisions, other U.S. federal agencies, and non-USG partners (e.g., stakeholder organizations, private sector entities, and research and academic institutions, etc.)