Growing and well-respected biomedical (clinical, basic and applied) research firm has openings at Ft. Belvoir. If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong benefits package, join the ClinicalRM team.
We are currently seeking a Biomedical Technician/Engineer III for the Ft. Belvoir, VA area.
The offeror shall serve as an advisor on all aspects of bioengineering, medical countermeasures, drug development, and portfolio management, to include bioengineering efforts, industry best practices, strategic relations, and medical transition activities. The offeror shall perform support and oversight functions from product conceptualization through implementation, including, but not limited to, the following:
Understanding capability gaps and assisting in setting project- and product-level strategy and priorities, ensuring portfolios are mapped to program goals
Providing expert analysis and engineering support of the design and development, installation and qualification, operation and validation of flexible, modular, single use system technologies in relation to biopharmaceutical manufacturing
Directing the activities of other bioengineers, as required
Advising the program team on risk assessment and risk management, technology portfolio and pipeline management, business and contracting strategies, technology transfers, and intellectual property management
Implementing and tracking EVM systems appropriate for pharmaceutical development within the constraints of the FDA approval process
Reviewing and assessing documentation (e.g., Alignment Charts; Research, Development and Acquisition Plans; Technology Development Strategy; TEMP; Life Cycle Management Plan; Acquisition Strategy; Modernization Plans, etc.)
Participating in Integrated Capability Teams and serve as technical point of contact, as required
Attending medical technical conferences (e.g., Medical Research Institute of Chemical Defense and Armed Forces Radiological Research Institute)
Performing discrete, special interest efforts to solve problems and complete studies
Participating in medical Focus Innovative Technologies (FITs), Solicitations for Efforts Exploratory Development (SEEDs), and related efforts with Joint Science and Technology Office (JSTO) and other agencies
The offeror shall establish and maintain relationships with relevant internal and external stakeholders in the CBD community (i.e., combat and materiel developers, systems engineers, test and evaluation entities, Industry, DoD, Department of Health and Human Services Biomedical Advanced Research and Development Authority, JSTO, FDA, and academic partners in order to evaluate current and emerging medical technologies and facilitate cross-communication regarding program priorities and courses of action.In addition, the offeror shall assist in determining the strategic direction of the organization, participating in technology demonstrations and directing Science and Technology (S&T) transitions.
Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
Performs light duties and other related duties as required and assigned.
Education: Successful completion of a full course of study in an accredited college or university leading to a Master’s Degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, is required. DAU Level III certification in PM or SPRDE, or the civilian equivalent, is preferred. A combination of a Bachelor’s Degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, DAU Level III certification in PM or SPRDE, and eight (8) years of experience may be substituted for a Master’s Degree.
General Experience: Eight (8) years of general experience and five (5) years of experience in a program office or similar organization
Specialized Knowledge and Skills: Expert knowledge in the development processes, relative to the DoD 5000 systems acquisition process, for medical products and systems is required, as well as experience in tailoring DoD acquisition policies to drug development and bio-surveillance activities. Display the ability to perform the following:
Developing Statements of Work, procurement requests, market surveys, and RFIs
Preparing and staffing recurring reports and milestone decision briefings
Creating resource-loaded schedules
Planning and executing IBRs and assisting with preparation of briefing charts to support internal and external Program Management Reviews
Must be able to work independently following a brief period of specific technical training.
Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM’s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks.
ClinicalRM is an Affirmative Action-Equal Opportunity Employer
“NorthCoast 99” Best Places to Work recipient
Clinical Research Management - 17 months ago