Position Sub-Title: JVAP Assistant Vaccine Managers

BIOENGINEER Level III

Requiring Office: JPM MCS Support Location: Ft. Detrick, MD – On-site Date Needed: 1 April 2015

# of FTEs: 2

Education and Experience Required

 Education: The contractor shall possess a Master’s degree in Biology, Biochemistry, Microbiology, Biochemical Engineering, or Pharmacology -AND- 5+ years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval)

 Alternate Education: The contractor shall possess a Bachelor of Science degree in Biology, Biochemistry, Microbiology, Biochemical Engineering, or Pharmacology -AND- 15+ years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval)

 Additional Education (desired): The contractor shall possess DAU Program Management Level II equivalency -OR- senior level DoD experience in pharmaceutical/biotechnology vaccine and drug development portfolio management (i.e., investment decisions based on the risk management process)

 The contractor shall possess strong analytical and problem solving skills, as well as good organization skills to balance and prioritize work

 The contractor shall have 5+ years of working experience with Microsoft Office, to include MS Outlook, MS Project, MS PowerPoint, MS Excel, and MS Word

Position Description

 The contractor shall serve as the assistant vaccine manager 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)

 The contractor shall serve on internal and external IPTs, responsible for organizing meetings, preparing agendas, documenting meeting minutes and action items, maintenance of document archive system, etc.

 The contractor shall participate in contractor site visits, assisting in monitoring performance and quality standards, and providing technical oversight during study execution  The contractor shall serve as the technical representative at conferences and stakeholder meetings

 The contractor shall 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

 The contractor shall 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

 The contractor shall provide written technical opinions to guide the decision making process of the IPT

 The contractor shall collaborate with project teams and participate in the evaluation of technical results in multiple developmental areas, developing strategies to move the program forward

 The contractor shall collaborate with both internal and external partners, contributing to data analyses in order to create and submit study results to publications or the FDA

 The contractor shall conduct research projects to produce effective solutions for maintaining cost, schedule, and performance parameters

 The contractor shall provide periodic update reports to program managers

 The contractor shall assist the program managers in assessing schedule risks and developing mitigation strategies

 The contractor shall draft and/or review acquisition documentation and presentations in support of major milestones, program reviews, or other program presentations

 The contractor shall 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)

 The contractor shall author, edit, and contribute in the development of robust product development plans to support FDA approval under the Animal Rule

 The contractor shall 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

o These activities will include collaboration with both internal and external partners  The contractor shall 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

 The contractor shall 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

 The contractor shall 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

 The contractor shall review and search scientific literature and databases in order to identify technical information and to provide references to support product development efforts

 The contractor shall support the Assistant Product Managers in developing program schedules, cost estimates, presentations, and other routine program management requirements

 The contractor shall work independently and as part of a team, and must have strong interpersonal and communication skills, both oral and written