SCIENTIST Level V
Requiring Office: JPM MCS
Team: CTO Support
Location: Ft. Detrick, MD – On-site
Responsibilities and Duties
- Provide support to the CTO, to include acting as the CTO’s representative on IPTs and at other meetings, managing taskers, drafting and reviewing documents, summarizing publications and data, and other related technical duties.
- 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, 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.
- Assist with outreach activities, to include organizing visits, preparing agendas, providing information to visitors, and documenting meeting summaries and action items.
- Assist the program managers in assessing schedule risks and developing mitigation strategies.
- Collaborate with project teams and participate in the evaluation of technical results in multiple developmental areas, developing strategies to move the program forward.
- Collaborate with both internal and external partners, contributing to data analyses in order to create and submit study results to publications or the FDA.
- Provide advice for the development of research projects to produce effective solutions for maintaining cost, schedule, and performance parameters.
- Provide written technical opinions to guide the decision making process of the IPT.
- Prepare and/or review draft protocols and study plans pertaining to a range of developmental efforts (i.e., manufacturing, non-clinical, clinical, and assay development), providing feedback in support of advanced development efforts.
- Provide technical input to acquisition documentation and presentations in support of major milestones, program reviews, or other program presentations.
- Author, edit, and contribute in the development of robust product development plans to support FDA approval under the Animal Rule.
- 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).
- Prepare documentation/presentations to summarize technical results, to include displaying results in “Layman’s” terms, formulating conclusions, and developing technical strategies in response to the data outcomes.
- Develop drafts and assist the project team to coordinate responsibilities, oversee quality 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 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.
- Provide bi-weekly update reports to the CTO.
Qualifications and Skills
- PhD in Engineering, Science, Business Management, Systems Management, or a related discipline (e.g., Molecular Biology, Biochemistry, Microbiology, Biochemical Engineering, etc.)
- 15 years of general experience and 10 years of relevant experience.
- Alternate/Tradeoff Requirement: Master’s degree in Engineering, Science, Business Management, Systems Management, or a related discipline (e.g., Molecular Biology, Biochemistry, Microbiology, Biochemical Engineering, etc.), as well as twenty (20) years of general experience and fifteen (15) years of relevant experience.
- Possess senior level experience in pharmaceutical/biotechnology vaccine and drug development portfolio management (i.e., investment decisions based on the risk management process).
- Possess extensive knowledge (topic of PhD thesis or key member of a team that successfully brought a vaccine to FDA licensure) of Virology or Vaccinology.
- Possess a solid understanding of applicable literature and be able to effectively debate highly technical issues with other contractors and develop work products at a level commensurate with this position.
- Possess expertise in program management, product development, acquisition program strategic planning, contract guidance, oversight, and advisory services.
- Possess a demonstrated proficiency in current Good Laboratory Procedures (cGLP); FDA Animal Rule requirements, application procedures, and implementation; FDA requirements for IND and NDA submission, approvals, and licensure; preparation for and conduct of DA Type A, B, and C meetings; and FDA qualification of drug development tools.
- Possess familiarity and expertise with all aspects of biologics cGMP (i.e., quality assurance, quality control, master cell bank production, working cell bank production validation, installation qualification, operating qualification, process qualification, engineering runs, process validation runs, consistency lot production, and biologics license application preparation).
- Possess experience aligning FDA processes with DoD acquisition requirements for the development and procurement of medical products and systems for biodefense.
- Possess the ability to work on a multi-disciplined team in a DoD acquisition environment.
- Possess the ability to perform multiple task simultaneously and rapidly redirect efforts based on changing requirements.
- Possess strong writing and oral communication skills.