Senior Scientist_ Biological Systems Engineer

Tunnell Government Services - Frederick, MD

Full-time

Senior Scientist/Biological Systems Engineer

Clearance: Secret

General

Provide overall program management support to assigned program/project. Assist the civilian Assistant Product Manager in scheduling meetings, preparing agendas and documenting meeting minutes. Organization of program documents on electronic data management system. Maintain and adhere to program and contractor IMS (integrated master schedule (MS Project)). Assist in the management of prime and subcontractor performers to ensure timely deliverables and program success. Develop and give programmatic briefs (PowerPoint) to senior leadership at IPR/JPR/Milestone Decision reviews. Assist in the financial aspects of program management in the development of life cycle cost estimates, POM submissions and reviewing contractor obligations and expenditures of funds.

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 and two (2) 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 eight (8) years of general experience and four (4) years of relevant experience.

Preferred: Regulatory Affairs certification is desired

Preferred: Project Scheduling Professional certification is desired

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 are desired.

Preferred: Drug-delivery device combination product experience.

The contractor shall possess three (3) years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).

· The contractor shall possess two (2) 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).

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 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 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.

· 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.

Job Type: Full-time

Experience:

  • relevant: 1 year (Preferred)
  • biotechnology drug development: 1 year (Preferred)
  • Drug-delivery device combination product: 1 year (Preferred)

License:

  • Regulatory Affairs (Preferred)
  • Security Clearance (Preferred)
  • Project Scheduling Professional certification (Preferred)
  • US Citizen (Preferred)