We are teaming with our partner to supply resources to support the DoD’s chemical and countermeasures program.

Review the descriptions below and respond to us at [email protected]com if you feel you may fit one of these bioengineer type jobs. You will be joining a dynamic team that has a long history in supporting these programs pre 911.
Act NOW! Don’t wait and miss out.

 

LCAT: Bioengineer
Level: III
GS Equivalent: 14
Requiring Office: Joint Project Manager Guardian (JPM G)
Team: Defense Biological Product Assurance Office (DBPAO)
Support Location: Ft. Detrick, MD – On-site
# of FTEs: 1
Sub-Title: Targeted Acquisition of Reference Materials Augmenting Capabilities (TARMAC) support
Clearance: Secret


Education, Experience and/or Certifications Required

  • Standard Requirement:  The contractor shall possess a Master’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as eight (8) years of general experience and five (5) years of relevant experience.
  • Tradeoff Requirement:  The contractor shall possess a Bachelor’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as ten (10) years of general experience and seven (7) years of relevant experience.
  • The contractor shall possess five (5) years of Industry experience in biotechnology, biochemistry, or other related scientific discipline.
  • The contractor shall possess five (5) years of project management experience in cost, schedule, performance, and risk analysis.
  • The contractor shall possess strong analytical and problem solving skills, as well as good organization skills to balance and prioritize work.
  • The contractor shall possess strong interpersonal and communication skills, both oral and written.
  • The contractor shall 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.
  • The contractor shall possess five years of working experience with Microsoft Office, to include Outlook, Project, PowerPoint, Microsoft Excel, and Word.
  • The contractor shall possess expertise in, product development, acquisition strategic planning, and/or contract documentation preparation.

Performance Based Tasks Required
· 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 products.
· The contractor shall serve on internal and external integrated product teams (IPTs), responsible for organizing meetings, preparing agendas, documenting meeting minutes and action items.
· The contractor shall participate in contractor site visits, assisting in monitoring performance, regulatory and quality standards, and providing technical oversight during production/manufacturing.
· The contractor shall serve as the programmatic representative at conferences and stakeholder meetings.
· The contractor shall provide technical knowledge to guide the product team through corrective/preventative actions.
· 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 internal and external partners and research projects to produce effective solutions for maintaining cost, schedule, and performance parameters.
· The contractor shall provide periodic update reports to Product Managers (PMs).
· The contractor shall assist the PMs in assessing cost and schedule risks and developing mitigation strategies.
· The contractor shall develop drafts and/or review and provide edits/comments to technical documentation (i.e., development/technology transition agreements, and standard operating procedures).
·  The contractor shall prepare and/or review draft protocols and study plans pertaining to a range of developmental efforts (assay development), providing feedback in support of advanced development efforts.
· 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 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 assist to identify and assess risks of new technologies and ongoing projects.
· The contractor shall prepare briefing materials.

  • The contractor shall provide technical oversight and project management support, acquisition program strategic planning, contract guidance, and advisory services for DBPAO commodities with little to no supervision.
  • The contractor shall serve as a subject matter expert on all program quality initiatives (e.g., internal and external International Standards Organization (ISO) accreditations, existence and completeness audits, quality assurance, quality control, etc.).
  • The contractor shall develop product test protocols (i.e., validation studies, stability studies, sampling plans with traceability to statistic models, and DBPAO assay design packages).

· The contractor shall provide technical input to acquisition documents and presentations in support of program reviews, or other program presentations.

 


 

LCAT: Bioengineer
Level: III
GS Equivalent: 14
Requiring Office: Joint Project Manager Medical Countermeasures Systems (JPM MCS)
Team: Joint Vaccine Acquisition Program (JVAP)
Support Location: Ft. Detrick, MD – On-site
# of FTEs: 2
Sub-Title: Assistant Vaccine Managers
Clearance: Secret
Education, Experience and/or Certifications Required

  • Standard Requirement:  The contractor shall possess a Master’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as eight (8) years of general experience and five (5) years of relevant experience.
  • Tradeoff Requirement:  The contractor shall possess a Bachelor’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as ten (10) years of general experience and seven (7) years of relevant experience.
  • The contractor shall posess DAU Level II equivalency in Program Management or senior-level DoD experience in pharmaceutical/biotechnology vaccine and 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.
  • The contractor shall possess five (5) years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).
  • The contractor shall possess five (5) years of project management experience in cost, schedule, performance, risk analysis, and advice.
  • The contractor shall possess strong analytical and problem solving skills, as well as good organization skills to balance and prioritize work.
  • The contractor shall possess extensive customer support/relations experience.
  • The contractor shall possess strong interpersonal and communication skills, both oral and written.
  • The contractor shall 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.
  • The contractor shall possess five years of working experience with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word.

Performance Based Tasks Required
· 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, and maintaining the document archive system.
· The contractor shall provide written technical opinions to guide the decision-making process of the IPT.
· The contractor shall participate in contractor site visits, assisting in monitoring performance, regulatory and quality standards, and providing technical oversight during study execution.
· The contractor shall serve as the programmatic 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, DoD acquisition processes, 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 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 provide periodic update reports to PMs.
· The contractor shall assist the PMs in assessing cost and 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 to 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.
· The contractor shall develop drafts and 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.
· 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 assist to identify and assess risks of new technologies and ongoing projects.
· The contractor shall interface with the stakeholder community to ensure office coordination.
· The contractor shall support the Assistant PMs in developing program schedules, cost estimates, presentations, and other routine program management requirements.
· The contractor shall work as a self-starter, both independently and as part of a team, as deputy to the Assistant Vaccine Manager.

 


 

LCAT: Bioengineer
Level: III
GS Equivalent: 14
Requiring Office: Joint Project Manager Medical Countermeasures Systems (JPM MCS)
Team: Chemical Defense Pharmaceuticals (CDP)
Support Location:  Ft. Detrick, MD – On-site
# of FTEs: 2
Sub-Title: Lead Scientist/Biological Systems Engineer
Clearance: Secret


Education, Experience and/or Certifications Required

  • Standard Requirement:  The contractor shall possess a Master’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as eight (8) years of general experience and five (5) years of relevant experience.
  • Tradeoff Requirement:  The contractor shall possess a Bachelor’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as ten (10) years of general experience and seven (7) years of relevant experience.
  • The contractor shall possess DAU Level I equivalency in Program Management or senior-level experience in pharmaceutical/biotechnology vaccine and 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.
  • The contractor shall possess five (5) years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).
  • The contractor shall possess five (5) years of project management experience in cost, schedule, performance, risk analysis, and advice.
  • The contractor shall possess experience in pharmaceutical/biotechnology 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 possess extensive customer support/relations experience.
  • The contractor shall possess strong interpersonal and communication skills, both oral and written.
  • The contractor shall 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.
  • The contractor shall possess five years of working experience with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word.
  • Desirable:  The contractor may possess a Regulatory Affairs certification.
  • Desirable:  The contractor may possess a Project Scheduling Professional certification.
  • Specifically, the contractor shall 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.

Performance Based Tasks Required
· 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 on internal and external IPTs, responsible for organizing meetings, preparing agendas, documenting meeting minutes and action items, and maintaining the document archive system.
· The contractor shall provide written technical opinions to guide the decision-making process of the IPT.
· The contractor shall participate in contractor site visits, assisting in monitoring performance, regulatory and quality standards, and providing technical oversight during study execution.
· The contractor shall serve as the programmatic 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, DoD acquisition processes, 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 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 collaborate with internal and external partners and research projects to produce effective solutions for maintaining cost, schedule, and performance parameters.
· The contractor shall provide periodic update reports to PMs.
· The contractor shall assist the PMs in assessing cost and 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 to 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.

  • 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 and regulatory management, and encourage timeliness of completion of protocols, IND applications, other regulatory submissions, and technical reports.
· de 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 assist to identify and assess risks of new technologies and ongoing projects.
· The contractor shall interface with the stakeholder community to ensure office coordination.
· The contractor shall prepare briefing materials.

 


 

LCAT: Bioengineer
Level: III
GS Equivalent: 14
Requiring Office: Joint Project Manager Protection (JPM P)
Team: JPM P Staff / Joint Product Lead Special Operations Forces Rapid Capability Development & Deployment (JPL SOF RCDD)
Support Location: Stafford, VA – On-site
# of FTEs: 1
Sub-Title: N/A
Clearance: Secret


Education, Experience and/or Certifications Required

  • Standard Requirement: The contractor shall possess a Master’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline (e.g., Natural Sciences, Business Administration, etc.), as well as eight (8) years of general experience and five (5) years of relevant experience.
  • Tradeoff Requirement: The contractor shall possess a Bachelor’s degree in in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline (e.g., Natural Sciences, Business Administration, etc.), as well as ten (10) years of general experience and seven (7) years of relevant experience.
  • The contractor shall possess five (5) years of project management experience in cost, schedule, performance, risk analysis, and advice.
  • The contractor shall possess two (2) years of experience in pre-clinical and clinical assays or diagnostics advanced development, e.g., FDA licensure requirements.
  • The contractor shall possess five (5) years of experience in Department of Defense (DoD) pharmaceutical/biotechnology vaccine and drug development portfolio management, e.g., investment decisions based on the risk management process.

Performance Based Tasks Required

  • The contractor shall have access to and use secure communications that include a classified computer and telecommunications to send and receive information to support the mission.
  • 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 on internal and external Integrated Product Teams (IPTs); shall organize meetings, prepare agendas, document meeting minutes and action items, etc.
  • The contractor shall serve as the technical point of contact, participate in contractor site visits, assisting in monitor performance and quality standards, and provide 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 to establish a link between clinical and non-clinical efficacy, develop a robust manufacturing strategy, and define 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, and develop strategies to move the program forward.
  • The contractor shall collaborate with both internal and external partners, and contribute to data analyses to create and submit study results to publications or the Food and Drug Administration (FDA).
  • The contractor shall conduct research projects to produce effective solutions for maintaining cost, schedule, and performance parameters.
  • The contractor shall provide periodic updates and reports to the Joint Product Lead and team members.
  • The contractor shall assist in schedule risks assessment and develop mitigation strategies.
  • The contractor shall provide technical input to acquisition documentation and presentations that support major milestones, program reviews, or other program requirements.
  • The contractor shall develop drafts and/or review and provide edits/comments to technical documentation, e.g., development/technology transfer reports, batch records, standard operating procedures, and regulatory submissions.
  • The contractor shall author, edit, and contribute to 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; e.g., manufacturing, non-clinical, clinical, and assay development; provide feedback to support advanced development efforts, and collaborate with 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, Investigational New Drug (IND) applications, regulatory submissions, and technical reports.
  • The contractor shall prepare documentation/presentations to summarize technical results that includes displaying results in “Layman’s” terms, formulating conclusions, and developing technical strategies in response to the data outcomes.
  • The contractor shall maintain currency on new technologies and methodologies that may benefit projects, critically assess technical proposals, provide written technical opinions on the feasibility of new technologies, and organize brown bag seminars to allow the Joint Product Offices to review 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 travel, commensurate with JPL SOF RCDD requirements.
    • The contractor shall acquire access to and use/operate the JPM P’s Secret Internet Protocol Router Network (SIPRNET) and Communications Security (COMSEC) telecommunications services.

 


 

LCAT: Bioengineer
Level: IV
GS Equivalent: 15
Requiring Office: Joint Project Manager Medical Countermeasures Systems (JPM MCS)
Team: Chemical Defense Pharmaceuticals (CDP)
Support Location: Ft. Detrick, MD – On-site
# of FTEs: 4
Sub-Title: Senior Scientist/Biological Systems Engineer
Clearance: Secret
Education, Experience and/or Certifications Required

  • Standard Requirement:  The contractor shall 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.
  • Tradeoff Requirement:  The contractor shall 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.
  • Preferred: DAU Level II equivalency in Program Management or senior level experience in pharmaceutical/biotechnology drug development portfolio management (i.e., investment decisions based on the risk management process) is desired. DAU courses will be at Government cost; however, travel costs (ex: Per Diem, lodging, mileage) will not be at Government cost.
  • Preferred: Certification in Program Management (such as from the Program Management Institute) is desired and will be at no cost to the Government.
  • Preferred: Regulatory Affairs certification is desired and will be at no cost to the Government.
  • Preferred: Project Scheduling Professional certification is desired and will be at no cost to the Government.
  • Preferred: 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 IMSs and financial documents is desired.
  • Preferred: Drug-delivery device combination product experience.
  • The contractor shall possess ten (10) years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).
  • The contractor shall possess five (5) years of experience in pre-clinical and clinical drugs, vaccines, biologics, assays, or device advanced development (IND to FDA licensure).
  • The contractor shall possess senior-level experience in pharmaceutical/biotechnology drug development portfolio management (i.e., investment decisions based on the risk management process).
  • The contractor shall 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.
  • The contractor shall possess five (5) years of working experience with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word.

Performance Based Tasks Required
· The contractor shall 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).
· The contractor shall serve as the technical/programmatic 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/programmatic 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 acquisition support in the areas of science and technology availability, technology maturity, and applicability of proposed candidate CBRN prophylactic and therapeutic drugs, biologics, and devices 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 conduct research projects to produce effective solutions for maintaining cost, schedule, and performance parameters.
· The contractor shall provide periodic update reports to leadership.
· The contractor shall assess schedule risks and develop mitigation strategies.
· The contractor shall prepare acquisition documentation and presentations in support of major milestones, program reviews, or other program presentations.
· The contractor shall 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 review documentation (e.g., draft protocols, study plans, etc.) pertaining to a range of developmental efforts (i.e., manufacturing, non-clinical, clinical, and assay development), providing feedback in support of advanced development efforts.

  • These activities will include collaboration with both internal and external partners.

· The contractor shall assist in leading the project team and coordinate responsibilities, oversee quality management, and encourage timeliness of completion of drafting or reviewing 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.
· 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 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.
· The contractor shall 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).
· The contractor shall collaborate with both internal and external partners, reviewing study results being submitted to publications or the FDA.
· The contractor shall prepare and/or review documentation pertaining to contracting (e.g., SOWs, RFPs, Task Orders, MOUs/MOAs, contract modifications, cost proposals, etc.)
· The contractor shall identify ways to fund the program, track program budget and spend plans, and assist in the yearly budget process and other finance-related activities.
· The contractor shall perform project assessment.  In addition, the contractor shall 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.)
· The contractor shall conduct risk planning, to include developing a risk management plan which identifies, analyzes, and prioritizes risks and defines risk response strategies.
· The contractor shall perform stakeholder analysis and then develop and maintain stakeholder registers.
· The contractor shall manage flow of project information.
· The contractor shall develop project requirements based upon organizational needs and mission, align expectations, and gain support for projects.

 


 

LCAT: Bioengineer
Level: IV
GS Equivalent: 15
Requiring Office:  Joint Project Manager Medical Countermeasures Systems (JPM MCS)
Team: Bio-Defense Therapeutics (BDTx)
Support Location: Ft. Detrick, MD – On-site
# of FTEs: 3
Sub-Title: Manager – Business and Analysis
Clearance: Secret


Education, Experience and/or Certifications Required

  • Standard Requirement:  The contractor shall 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.
  • Tradeoff Requirement:  The contractor shall 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.
  • The contractor shall possess a DAU Level II equivalency in Program Management or senior level DoD experience in pharmaceutical/biotechnology vaccine and 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.
  • The contractor shall possess ten (10) years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).
  • The contractor shall possess five (5) years of experience in pre-clinical and clinical drugs, vaccines, biologics, assays, or diagnostics advanced development (IND to FDA licensure).
  • The contractor shall possess 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 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.
  • The contractor shall possess five (5) years of working experience with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word.



Performance Based Tasks Required
· The contractor shall 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).
· The contractor shall serve as the technical/programmatic 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/programmatic 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 acquisition support in the areas of science and technology availability, technology maturity, and applicability of proposed candidate CBRN prophylactic and therapeutic drugs, biologics, and devices 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 conduct research projects to produce effective solutions for maintaining cost, schedule, and performance parameters.
· The contractor shall provide periodic update reports to leadership.
· The contractor shall assess schedule risks and develop mitigation strategies.
· The contractor shall prepare acquisition documentation and presentations in support of major milestones, program reviews, or other program presentations.
· The contractor shall 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 review documentation (e.g., draft protocols, study plans, etc.) pertaining to a range of developmental efforts (i.e., manufacturing, non-clinical, clinical, and assay development), providing feedback in support of advanced development efforts.

  • These activities will include collaboration with both internal and external partners.

· The contractor shall assist in leading the project team and coordinate responsibilities, oversee quality management, and encourage timeliness of completion of drafting or reviewing 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.
· 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 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.
· The contractor shall 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).
· The contractor shall assist Government personnel in leading requirements generation efforts and development of RFPs, RFIs, SOOs, and other source selection documentation.
· The contractor shall participate in source selection activities, providing advice and assistance on the technical and programmatic value and feasibility of proposals to the Government.
· The contractor shall assist Government personnel in leading the analysis and documentation required for all contracting actions.
· The contractor shall assist Government personnel in leading the development and implementation of program planning budget and execution strategies, tracking and monitoring obligations and expenditures.

 


 

LCAT: Bioengineer
Level: IV
GS Equivalent: 15
Requiring Office: Joint Project Manager Medical Countermeasures Systems (JPM MCS)
Team: Diagnostics (Dx)
Support Location: Ft. Detrick, MD – On-site
# of FTEs: 1
Sub-Title: Scientist
Clearance: Secret
Education, Experience and/or Certifications Required

  • Standard Requirement:  The contractor shall 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 in pre-clinical and clinical drugs, vaccines, biologics, assays, or diagnostics advanced development (IND to FDA licensure).
  • Tradeoff Requirement:  The contractor shall possess a Bachelor’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as twenty (20) years of general experience and fifteen (15) years of relevant experience in pre-clinical and clinical drugs, vaccines, biologics, assays, or diagnostics advanced development (IND to FDA licensure).
  • The contractor shall possess a working proficiency with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word.

Performance Based Tasks Required
· The contractor shall serve as the technical representative at conferences and stakeholder meetings.
· The contractor shall provide scientific/technology advice, technical oversight, and acquisition support in the areas of science and technology availability, technology maturity, and applicability of candidate CBRN diagnostic devices and assays 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 conduct research projects to produce effective solutions for maintaining cost, schedule, and performance parameters.
· The contractor shall provide periodic update reports to leadership.
· The contractor shall 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.
· The contractor shall review documentation (e.g., draft protocols, study plans, etc.) pertaining to a range of developmental efforts (i.e., manufacturing, non-clinical, clinical, and assay development), providing feedback in support of advanced development efforts.

  • These activities will include collaboration with both internal and external partners.

· The contractor shall assist in leading the project team and coordinate responsibilities, oversee quality management, and encourage timeliness of completion of drafting or reviewing 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.
· 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 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.
· The contractor shall 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).
· The contractor shall provide technical, scientific, and programmatic support to the program office Senior Scientist and project teams for advanced development efforts (i.e., clinical, non-clinical, and manufacturing) related to medical diagnostics for CBR threats.

 


 

LCAT: Bioengineer
Level: IV
GS Equivalent: 15
Requiring Office: Joint Project Manager Medical Countermeasures Systems (JPM MCS)
Team: Diagnostics (Dx)
Support Location: Ft. Detrick, MD – Off-site
# of FTEs: 1
Sub-Title: Manager – Business & Analysis
Clearance: Secret


Education, Experience and/or Certifications Required

  • Standard Requirement:  The contractor shall possess a Master’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as five (5) years of general experience or three (3) years of relevant experience in pre-clinical and clinical drugs, vaccines, biologics, assays, or diagnostics advanced development (IND to FDA licensure).
  • Tradeoff Requirement:  The contractor shall possess a Bachelor’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline, as well as six (6) years of general experience or four (4) years of relevant experience in pre-clinical and clinical drugs, vaccines, biologics, assays, or diagnostics advanced development (IND to FDA licensure).
  • The contractor shall 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.
  • The contractor shall possess a working proficiency with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word.
  • The contractor shall possess experience in project management (i.e., cost, schedule, performance, risk analysis, and advice) and/or pre-clinical and clinical assays or diagnostics advanced development (FDA licensure requirements).

Performance Based Tasks Required
· The contractor shall serve as the technical representative at conferences and stakeholder meetings.
· The contractor shall provide scientific/technology advice, technical oversight, and acquisition support in the areas of science and technology availability, technology maturity, and applicability of  candidate CBRN diagnostic devices and assays 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 provide periodic update reports to leadership.
· The contractor shall prepare acquisition documentation and presentations in support of major milestones, program reviews, or other program presentations.
· The contractor shall 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 review documentation (e.g., draft protocols, study plans, etc.) pertaining to a range of developmental efforts (i.e., manufacturing, non-clinical, clinical, and assay development), providing feedback in support of advanced development efforts.

  • These activities will include collaboration with both internal and external partners.

· The contractor shall assist with Government oversight of development contractor efforts, to include conducting site visits, assisting in monitoring performance and quality standards, and providing technical oversight during study execution.
· 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.
· 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 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.
· The contractor shall 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).

 


 

LCAT: Bioengineer
Level: IV
GS Equivalent: 15
Requiring Office: Joint Project Manager Medical Countermeasures Systems (JPM MCS)
Team: Chief Technical Officer (CTO)
Support Location: Ft. Detrick, MD – On-site
# of FTEs: 1
Sub-Title: N/A
Clearance: Secret
Education, Experience and/or Certifications Required 

  • Standard Requirement:  The contractor shall possess a PhD 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.
  • Tradeoff Requirement:  The contractor shall possess a Master’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.
  • The contractor shall possess a DAU Level II equivalency in Program Management or senior level DoD experience in pharmaceutical/biotechnology vaccine and 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.
  • The contractor shall possess ten (10) years of hands-on Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).
  • The contractor shall possess five (5) years of experience in pre-clinical and clinical drugs, vaccines, biologics, assays, or diagnostics advanced development (IND to FDA licensure).
  • The contractor shall possess 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 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.
  • The contractor shall possess five (5) years of working experience with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word.
  • The contractor shall possess five (5) years of experience performing or overseeing pre-clinical and clinical activities within medical countermeasures, assay, and/or diagnostics advanced development (pre-submission to FDA licensure).
  • The contractor shall possess previous support experience serving as a technical lead, with experience writing or reviewing multiple pre-submission applications, 510(k) submissions, an understanding of CLIA-waived applications, clinical trial protocols, regulatory submissions, or technical reports.

Performance Based Tasks Required
· The contractor shall 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).
· The contractor shall serve as the technical/programmatic 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/programmatic 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 acquisition support in the areas of science and technology availability, technology maturity, and applicability of proposed candidate CBRN prophylactic and therapeutic drugs, biologics, and devices 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 conduct research projects to produce effective solutions for maintaining cost, schedule, and performance parameters.
· The contractor shall provide periodic update reports to leadership.
· The contractor shall assess schedule risks and develop mitigation strategies.
· The contractor shall prepare acquisition documentation and presentations in support of major milestones, program reviews, or other program presentations.
· The contractor shall 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 review documentation (e.g., draft protocols, study plans, etc.) pertaining to a range of developmental efforts (i.e., manufacturing, non-clinical, clinical, and assay development), providing feedback in support of advanced development efforts.

  • These activities will include collaboration with both internal and external partners.

· The contractor shall assist in leading the project team and coordinate responsibilities, oversee quality management, and encourage timeliness of completion of drafting or reviewing 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.
· 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 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.
· The contractor shall 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).

  • The contractor shall assist in monitoring new technologies and assessing their potential to become new products.
  • The contractor shall participate in Government, academic, and Industry groups where there are opportunities to gain technical insights related to DoD requirements.
  • The contractor shall participate in outreach efforts, providing logistical support, identifying speakers, and participating in TechWatch presentations.

 


 

LCAT: Bioengineer
Level: IV
GS Equivalent: 15
Requiring Office: Joint Project Manager Medical Countermeasures Systems (JPM MCS)
Team: Bio-Defense Therapeutics (BDTx)
Support Location: Ft. Detrick, MD – On-site
# of FTEs: 1
Sub-Title: Manager – Business and Analysis
Clearance: Secret
Education, Experience and/or Certifications Required

  • Standard Requirement:  The contractor shall 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.
  • Tradeoff Requirement:  The contractor shall 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.