Odyssey Systems is currently seeking an experienced Senior Product Manager to provide support to the U.S. Army Medical Materiel Development Activity (USAMMDA) Force Health Protection (FHP) Division, a subordinate command under United States Army Medical Research and Development Command (USAMRDC).

As the Senior Product Manager you will support the  mission to make available to DoD personnel Investigational New Drugs (INDs) under approved treatment protocols.

***Contingent upon contract award***

Duties include, but not limited to:

• Provide scientific review and technical support to the FHPDivision products in support of the Director, Deputy Director, and Product Managers in the FHP
• Respond to technical and scientific related questions related to products in the FHPportfolio in the areas of infectious diseases, bio-threats or molecular diagnostics.
• Review the regulatory requirements for inventorying, archiving, storing, and transporting INDvaccines, drugs, as well as other treatments, prophylaxis, diagnostics, or devices.
• Support the planning, development, and review of Expanded Access INDprotocols and their rollouts. Support FHP involvement in any Emergency Use Authorization (EUA) as needed.
• Develop and maintain expertise and training in Good Clinical Practice regulations.
• Demonstrate superior knowledge of and be able to provide top-level technical reviews of Good Laboratory Practices (GLP) reports, annual reports, and similar data for products in the FHP Working knowledge of Current Good Manufacturing Practices (cGMP).
• Ensure compliance of the FHPportfolio of Expanded Access protocols with all applicable FDA, DoD, and local regulations and requirements.
• Review and analyze technical documents and make recommendations to ensure that sound scientific processes are used to support the Special Immunizations Program (SIP) portfolio of investigational vaccines. Ensure those processes and any deliverables meet all federal regulatory requirements for the use of investigational products.
• Maintain current knowledge of relevant technology and industry developments.
• Participate in special projects as required.

Minimum Required Qualifications:

Citizenship: Must be a US citizen

Clearance: Must be able to obtain and maintain a NACI Clearance and CAC card

Education: Bachelors Degree in a science discipline such as virology or microbiology

Years’ experience: 10 years’ related experience in scientific knowledge in areas of infectious diseases, bio-threats or molecular diagnostics.

• Experience as a scientific subject matter expert, responding to technical and scientific questions and provide support of the review of regulatory requirements for product compliance, inventory management, archiving, and storage of vaccines, drugs, as well as other treatments, prophylaxis, diagnostics, or devices
• Proven understanding of FDArules and regulations regarding IND protocol submission, product compliance and management
• Working understanding of Good Clinical Practice (GCP), Good Laboratory Practices (GLP) and Current Good Manufacturing Practices (cGMP).

Preferred Qualifications:

Education: Doctoral Degree preferred

Additional Information:

Location: Onsite in Frederick, MD (local candidates only); Telework eligible

***Contingent upon contract award***

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Odyssey Systems Consulting Group, is an innovative small business committed to providing world-class technical, management, and training support services to government and public sector clients. We focus on people, processes, and performance to deliver superior results. Since our inception in 1997, our commitment to mission success and customer satisfaction has been recognized with exponential growth and exceptional past performance ratings. We accept challenging assignments and drive projects from the planning stages, through implementation, and into operations and support.

Please note: Final compensation for this position will be determined by various factors such as the Federal Government contract labor categories and contract wage rates, relevant work experience, specific skills and competencies, geographic location, education, and certifications.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities