Senior Product Manager (Force Health Protection)

Position: Senior Product Manager (Force Health Protection)
Location: Hybrid, at the facility in Fredrick, MD
Clearance Required: Public Trust is required. Must be able to obtain a NACI Clearance and CAC card
Salary Range: PROPOSAL Position - Salary Range Pending Based on Award of Contract
Knowesis is currently seeking an experienced Senior Product Manager to support the United States Army Medical Materiel Development Activity (USAMMDA) at Ft. Detrick, MD, to Force Health Protection (FHP) Division in its mission to make available to DoD personnel Investigational New Drugs (INDs) under approved treatment protocols. USAMMDA is responsible for developing medical products such as drugs, vaccines, devices, and medical support equipment. USAMMDA preserves and protects the lives of warfighters by developing medical products to ensure readiness and the highest quality of medical care for DoD personnel.
This position requires a Public Trust security clearance. Must obtain and maintain a NACI clearance and a CAC Card. Additionally, U.S. Citizenship is required (applicants without proof of U.S. Citizenship will not be considered due to the position’s security clearance requirement).
Duties and Responsibilities include but are not limited to:

• Participate in special projects as required.
• Ensure compliance of the FHP portfolio of Expanded Access protocols with all applicable FDA, DoD, and local regulations and requirements
• Review and analyze technical documents and make recommendations to ensure 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
• Support the planning, development, and review of Expanded Access IND protocols and their rollouts. Support FHP involvement in any Emergency Use Authorization (EUA) as needed
• Provide scientific review and technical support to the FHP Division products in support of the Director, Deputy Director, and Product Managers in the FHP Division
• Review the regulatory requirements for inventorying, archiving, storing, and transporting IND vaccines, drugs, as well as other treatments, prophylaxis, diagnostics, or devices
• Respond to technical and scientific related questions related to products in the FHP portfolio in the areas of infectious diseases, bio-threats, or molecular diagnostics
• 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 portfolio. Working knowledge of Current Good Manufacturing Practices (cGMP)

Skills/Qualifications:

• Master’s Degree in a science discipline such as virology or microbiology
• Ten years of related experience in scientific knowledge in areas of infectious diseases, bio-threats, or molecular diagnostics.
• Working knowledge of Good Clinical Practice (GCP), Good Laboratory Practices (GLP), and Current Good Manufacturing Practices (cGMP)
• Experience as a scientific subject matter expert, responding to technical and scientific questions and providing support for 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
• Ability to obtain a NACI public trust
• U.S. Citizenship required
• Proven understanding of FDA rules and regulations regarding IND protocol submission, product compliance, and management

Preferred Qualifications:

• Doctorate Degree

Required Education Level:

• Master’s Degree in a science discipline such as virology or microbiology

Knowesis is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.