BARDA Senior Scale-up Manufacturing Facilities Subject Matter Expert

BryceTech • Full Time • Washington, District of Columbia, United States • 2w ago

Job Description

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.

Senior Scale-up Manufacturing Facilities Subject Matter Expert Specific Responsibilities.

Apply expert ability to deliver work products related to the development and management of product scale-up manufacturing processes, construction, engineering, commissioning, and validation.
Supervise less experienced Scale-Up Manufacturing Facilities Subject Matter Experts.
Coordinate with program managers, scientists, and other subject matter experts as required.
Serve as the primary interface between BARDA and Industry Partner senior leadership on scale-up manufacturing matters.
Perform downstream processing development activities and optimization of manufacturing processes including formulation.
Assist if required in the development/optimization of upstream manufacturing processes, including cell line development.
Participate to the technology transfer and scale-up to contract manufacturing organization.
Review manufacturing documentation
Provide technical support during process development and manufacturing activities.
Participate to process improvements projects (e.g., process robustness, control, and cost of good (COGs)).
Assist in the design and execution of experimental plans to understand the process and its robustness (Identification and characterization of Critical Process Parameters and of Critical Quality Attributes).
Perform process characterizations studies (e.g., viral clearance studies, resin reuse, process limit evaluations).
Prepare investigation reports on deviations from the GMP manufacturing process.
Set-up and execute process development experiments as required.
Responsible for experimental data analysis and documentation.
Keep abreast of current development and process technology trends in the field.
Apply expert knowledge of Good Manufacturing Practices in a regulated environment (pharmaceutical)
Apply expert knowledge of upstream and downstream processes technologies.
Ability to work in cross-functional teams and in a fast-paced environment.