The Scientist/Subject Matter Expert (SME)in Blood Research Programs will support the U.S. Army Medical Materiel Development Activity (USAMMDA) in the Warfighter Protection and Acute Care (WPAC) Project Management Office (PMO). This position is located at Fort Detrick, Maryland. Responsibilities are as follows:
Serve as an Advisor/SME in the area of Blood and Blood Products, Blood Research, Blood Product Operations, and other Combat Casualty Care Products or Devices to include traumatic hemorrhage, brain injury, hematology, and transfusion medicine.
Provide proactive, top level technical expert support to WPAC and support the advanced development requirements for medical products.
Act as integral member of Integrated Product Teams (IPT), decision gate meetings, program briefings, and product acquisition in combat casualty care product portfolio.
Proactively involved in the review process of clinical protocols and associated clinical trial documents, various regulatory applications, and Food and Drug Administration (FDA) recommendations.
Review for technical correctness and give expert analysis on highly specialized tasks including design and evaluation of non-clinical studies, development of clinical trial designs, review of non-clinical study reports, and inputs into the chemistry, manufacturing and controls of biologics, drugs and devices.
Work closely with the advanced development team to facilitate initial development design sessions of major product initiatives and associated activities.
Successfully communicate with personnel at various echelons through the use of effective interpersonal and communication skills.
Manage numerous efforts and effectively prioritize and multi-task requirements that have a direct impact on the Program.
Maintain current knowledge of relevant technology and industry developments through independent market research.
Participate in various meetings both internally and externally to the organization.
Support the DoD Acquisition Lifecycle and document preparation.
Attend and participate in site visits, off-site meetings and briefings, sub-working group and investigator meetings to obtain and evaluate project status.
Assess and monitor the risks associated with clinical development of blood and blood products.
Independently perform activities consistent with established organizational practices, precedents, policies and strategic objectives set forth by WPAC leadership.
Participates in special projects as required.
Required Qualifications
Masters’ Degree in related scientific discipline; Ph.D. preferred.
10+ years of related experience.
Experience in medical product development, regulatory submission (INDs, NDAs, BLAs, 510(k)s and PMAs) and guidance and management of projects related to premarket and post-market applications.
Experience with DOD 5000 Acquisition Processes.
Experience with MS Office (Outlook, TEAMS, Word, Excel, PowerPoint) and SharePoint
US Citizen.
Ability to obtain T1 (Public Trust) – NACI Clearance.
Must be able to pass background and drug testing.
THIS IS A FEDERAL CONTRACT.
Position may be flexible (remote work, hours, part-time/full-time) for the right person.
About Allied Technologies and Consulting
Allied Technologies and Consulting, LLC is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
ATC is a Minority Owned, Service-Disabled Veteran Owned Small Business (SDVOSB) and ISO 9001:2015 certified company. We deliver quality products and services that focus on professional and technical solutions designed to make our clients successful in their missions.
Our clients include Department of Defense (DOD), Health and Human Services (HHS) and other Commercial Entities. Our company prides itself on responsive customer relations and consistent achievement in reaching our customers business goals. We have established an ethically based and diverse professional service organization built on quality business principles of integrity, excellence, service, and value. We consistently apply these principles in our relationships with our customers and our staff.
