BIOENGINEER
Level III
Requiring Office: JPM MCS
Support Location: Ft. Detrick, MD – On-site
Date Needed: 19 August 2014 / 1 April 2015
# of FTEs: 2
Position Sub-Title: CTO
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: 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 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 technical representative 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 as the technical lead on internal and external IPTs, responsible for
organizing meetings, preparing agendas, documenting meeting minutes and action items, etc.

The contractor shall serve as the technical point of contact, participating 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 provide technical input to 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
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
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