BARDA Manufacturing Program Manager

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

Job Description

Program Manager Responsibilities - General.

Provide concept ideas for BARDA Program Division(s); Prepare draft work statements (SOW, SOO, PWS) for solicitations [Request for Information (RFIs), Request for Proposals (RFPs), Sources Sought Notices (SSN), et al].
Review and advise on contract proposals (formally and informally submitted), as requested.
Provide project development level portfolio management and oversight.
Provide program level portfolio management and oversight.
Develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts.
Assist in contract negotiations on technical matters, as requested.

Manufacturing PM Specific Responsibilities

Provide SME in biopharmaceutical process and manufacturing infrastructure development manufacturing technology trends, and biomedical emergency preparedness & response.
Provide program/project management & executive decision support for related projects.
Assist new acquisitions, development of medical countermeasure (MC) and related manufacturing infrastructure, optimization of MC stockpiles, surveys & gap analyses, biomedical emergency response and ramp-down logistics, budget planning, development, and application of program/project management tools.
Provide SME in the design, engineering, construction, and validation of biopharmaceutical manufacturing facilities.
Review manufacturing elements (premarket, compliance, and post-market surveillance) of regulatory submissions. Actions may include 510(k)s, PMAs, De Novos, IDEs, pre-submissions, submission issue requests, 513(g)s, recalls and complaint submissions.
Assist with the developing, modifying, and evaluating guidelines concerning data required in manufacturing actions to be submitted to BARDA.
Present reviews, conclusions, opinions, and recommendations to appropriate scientific review panels on PMAs, petitions for reclassification, etc.