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Remote - Drug Vaccine Clinical Development - BioPharma - Government

DAK Resources Washington, DC
  • Expired: January 19, 2021. Applications are no longer accepted.

Job DescriptionRemote$108 KFull TimeSenior SME Drug/Vaccine/Diagnostic/Clinical DevelopmentDuties and Responsibilities: Provide subject matter expertise in drug and/or vaccine manufacturing to the BARDA PCI Division for the execution of multiple research and development programs. Develop drug and/or vaccine manufacturing plans based on regulatory requirements Assist in managing program portfolios and providing oversight on projects and product development to ensure all requirements are addressed. Able to communicate technical information effectively both orally and written(briefing presentations, technical documents, etc.) Evaluate potential COVID-19 MCM products for technical feasibility, alignment with BARDA's strategic response plan, and potential entrance into the portfolio.

Provide SME support to evaluate programs, proposals and plans, and program metrics for technical and programmatic merit, as well as to identify risks, mitigation strategies, and... potential areas of improvement. Provide SME support to assist with the vision, design, acquisition, and execution of programs in support of the Government Program Director(s).

Support BARDA's further collaboration with interagency partners. Coordinate and integrate amongst BARDA PCI Directors and potential stakeholders, interagency partners, and user communities regarding areas of collaboration, needs, emerging industrial and academic capabilities, and technologies. Identify and review emerging requirements and opportunities for the transition of selected technology programs.

Identify, evaluate and accelerate innovative projects to advance BARDA PCI initiatives. Provide subject matter expertise in drug and vaccine manufacturing at all stages of product developmentThis position will serve as a scientific/technical advisor as follows: Work as part of an interdisciplinary team to assist BARDA contractors to develop valid, high-yielding, and economical processes as well as analytical methods for the production of biopharmaceutical products Evaluate contractor's risk management programs for product development processes and assist in their modification as needed Generate contingency risk reduction plans Provide subject matter expertise in drug and/or vaccine manufacturing to the BARDA PCI Division for the execution of multiple research and development programs. Develop drug and/or vaccine manufacturing plans based on regulatory requirements Assist in managing program portfolios and providing oversight on projects and product development to ensure all requirements are addressed.

Able to communicate technical information effectively both orally and written(briefing presentations, technical documents, etc.) Evaluate potential COVID-19 MCM products for technical feasibility, alignment with BARDA's strategic response plan, and potential entrance into the portfolio. Provide SME support to evaluate programs, proposals and plans, and program metrics for technical and programmatic merit, as well as to identify risks, mitigation strategies, and potential areas of improvement. Provide SME support to assist with the vision, design, acquisition, and execution of programs in support of the Government Program Director(s).

Support BARDA's further collaboration with interagency partners. Coordinate and integrate amongst BARDA PCI Directors and potential stakeholders, interagency partners, and user communities regarding areas of collaboration, needs, emerging industrial and academic capabilities, and technologies. Identify and review emerging requirements and opportunities for the transition of selected technology programs.

Identify, evaluate and accelerate innovative projects to advance BARDA PCI initiatives. Provide subject matter expertise in drug and vaccine manufacturing at all stages of product developmentThis position will serve as a scientific/technical advisor as follows: Work as part of an interdisciplinary team to assist BARDA contractors to develop valid, high-yielding, and eco

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