Chemist / Scientist CBRN Level IV – Fort Detrick

*Chemist / Senior Scientist – Fort Detrick* Venesco LLC is looking for a Scientist Level IV to support Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) at Fort Detrick, MD.
We are looking for a premier scientist with 12 years experience.
Experience must include work with medical decontamination products, sulfur mustard, rad/nuc and/or nerve agent medical countermeasures.
On-site (2-3 days a week) is expected, but for the right person, *fully-remote will be considered.
* *US Citizenship with eligibility for Secret Clearance* is required.
*Education, Experience and/or Certifications Required* * Standard Requirement: The contractor shall possess a Master’s degree in Chemistry, Biology, or a related discipline, as well as twelve (12) years of general experience and eight (8) years of relevant experience.
* The contractor shall possess at least ten (10) years of experience in pharmaceutical/ biotechnology and drug development / advanced development (IND to FDA approval) and portfolio management (i.
e.
, investment decisions based on the risk management process).
The contractor shall possess at least five (5) years of recent experience in pre-clinical and clinical drug development including, protocol development and execution, advanced development (IND to FDA approval) specific to nerve agent, toxins, toxicants and/or chemical related medical countermeasures inclusive of a general understanding of manufacturing of chemical products and autoinjectors.
* Experience with medical decontamination products, sulfur mustard, rad/nuc and/or nerve agent medical countermeasures required.
* The contractor shall possess expertise 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, 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 be the technical lead on protocol development, work with the performer during all facets of the product development, serve as the SME on planned development activities for new start programs, address risks to the program, and draft or review reports and summaries.
* 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 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.
Venesco LLC, is an equal opportunity and affirmative action employer.
Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or status as an individual with a disability.
Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.
Job Type: Full-time Benefits: * 401(k) * Dental insurance * Health insurance * Paid time off * Tuition reimbursement * Vision insurance Schedule: * 8 hour shift Education: * Master's (Preferred) Experience: * Pharmaceutical / biotechnology (IND to FDA approval): 10 years (Preferred) * clinical, non-clinical, and manufacturing: 10 years (Preferred) * pre-clinical and clinical drug development: 5 years (Preferred) * nerve agent, toxins, toxicants and/or chemical: 5 years (Required) Security clearance: * Secret (Preferred) Work Location: Remote