Bioengineer IV - Military Veterans

The Alakaina Foundation Family of Companies (FOCs) has a need for a Bioengineer IV   to support our government customer located in Ft. Detrick, MD .   DESCRIPTION OF RESPONSIBILITIES:   Serve as the technical representative/integrator on project teams, supporting risk planning efforts and providing advice and assistance in implementing process improvements for advanced development efforts (i.e., clinical, non-clinical, and manufacturing). Serve on internal and external IPTs, responsible for organizing meetings, preparing agendas, documenting meeting minutes and action items, and maintaining the document archive system. Provide written technical opinions to guide the decision-making process of the IPT. Participate in contractor site visits, assisting in monitoring performance, regulatory and quality standards, and providing technical oversight during study execution. Serve as the programmatic representative at conferences and stakeholder meetings. Provide scientific/technology advice, technical oversight, and project management support in the areas of science and technology availability, technology maturity, and applicability of proposed candidate CBRN medical countermeasures through advanced development, DoD acquisition processes, production, and fielding. Provide technical knowledge to guide the product team in establishing a link between clinical and non-clinical efficacy, developing a robust manufacturing strategy, and defining product development schedules. Collaborate with project teams and participate in the evaluation of technical results in multiple developmental areas, developing strategies to move the program forward. Propose effective management solutions for maintaining cost, schedule, and performance parameters. Collaborate with both internal and external partners, contributing to data analyses in order to create and submit study results to publications or the FDA. Collaborate with internal and external partners and research projects to produce effective solutions for maintaining cost, schedule, and performance parameters. Provide periodic update reports to PMs and leadership. Assess cost, schedule and performance risks and develop mitigation strategies. Draft and/or review acquisition documentation and presentations in support of major milestones, program reviews, or other program presentations. Develop drafts and/or review and provide edits/comments to technical documentation (i.e., development/technology transfer reports, batch records, standard operating procedures, and regulatory submissions). Author, edit, and contribute to the development of robust product development plans to support FDA approval. Assist the project team to coordinate responsibilities, oversee quality and regulatory management, and encourage timeliness of completion of protocols, IND applications, other regulatory submissions, and technical reports. Maintain current knowledge on new technologies and methodologies that may benefit the program, assessing technical proposals critically and effectively, providing written technical opinion on the feasibility of new technologies, and organizing brown bag seminars to allow the Joint Product Offices to review the technologies. Review and search scientific literature and databases in order to identify technical information and to provide references to support product development efforts. Assist to identify and assess risks of new technologies and ongoing projects. Interface with the stakeholder community to ensure office coordination. Prepare and deliver briefing materials. Effectively communicate results of assigned tasks and efforts, both orally and in written form, in a clear and concise manner, to include executive summaries, meeting presentations, documentation, and reports. Deliver written work products no later than the assigned suspense (which will be earlier than those established by external sources (e.g., SASI, DSS, higher headquarters suspense dates, etc.) to allow for Government review, revision, and coordination prior to Government approval and submission). Prepare and/or review documentation pertaining to contracting (e.g., SOWs, RFPs, Task Orders, MOUs/MOAs, contract modifications, cost proposals, etc.) Identify ways to fund the program, track program budget and spend plans, and assist in the yearly budget process and other finance-related activities. Perform project assessment. In addition, Participate in the development of project charters for new programs by compiling and analyzing gathered information (e.g., historical data, organizational factors, government requirements, stakeholder interest, etc.) Conduct risk planning, to include developing a risk management plan which identifies, analyzes, and prioritizes risks and defines risk response strategies. Perform stakeholder analysis and then develop and maintain stakeholder registers. Manage flow of project information. Develop project requirements based upon organizational needs and mission, align expectations, and gain support for projects Other duties as assigned.  REQUIRED DEGREE/EDUCATION/CERTIFICATION:   Possess a Master’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as ten (10) years of general experience and six (6) years of relevant experience Possess a Bachelor’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as twelve (12) years of general experience and eight (8) years of relevant experience. Certification in Program Management (such as from the Program Management Institute) is desired   REQUIRED SKILLS AND EXPERIENCE:   Possess DAU Level II equivalency in Program Management or senior-level experience in pharmaceutical/biotechnology device and/or drug development portfolio management (i.e., investment decisions based on the risk management process). DAU courses will be at Government cost; however, travel costs (ex: Per Diem, lodging, mileage) will not be at Government cost. Possess ten (10) years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval). Possess intermediate-level experience in pharmaceutical/biotechnology drug development portfolio management (i.e., investment decisions based on the risk management process). Possess familiarity with, and have participated in, the discussion, preparation, and review of cycles required for program management, product development, acquisition program strategic planning, contract guidance, oversight, and advisory services. Have familiarity with earned value management, integrated master schedules and reviewing invoices and spend plans. Possess strong analytical and problem-solving skills, as well as good organization skills to balance and prioritize work. Possess extensive customer support/relations experience. Possess strong interpersonal and communication skills, both oral and written. Be capable of maintaining interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge across and within organizations united for the development of medical countermeasures. Possess five years of working experience with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word.   DESIRED SKILLS AND EXPERIENCE:   Possess a Regulatory Affairs certification Possess a Project Scheduling Professional certification. Specifically possess sufficient experience in the use of Microsoft Project and Microsoft Excel to provide a level of proficiency that allows independent development and management of resource loaded Integrated Master Schedules (IMSs) and financial documents.   REQUIRED CITIZENSHIP AND CLEARANCE:   Must be a U.S. Citizen Must have active Secret clearance or ability to obtain.   ​The Alakaina Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries. Eligible full-time employees enjoy a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.   We are an Equal Opportunity/Affirmative Action Employer. We are proud to state that we do not discriminate in employment decisions on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. If you are a person with a disability and you need an accommodation during the application process, please click   here   to request accommodation. We E-Verify all employees.   The Alakaina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Keaki Technologies, Laulima Government Solutions, Kūpono Government Services, and Kāpili Services, Pookela Solutions, Kīkaha Solutions, LLC, and Pololei Solutions, LLC. Alakaina Foundation activities principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.   For additional information, please visit www.alakainafoundation.com .      #LI-JS1   #ClearanceJobs