Venesco LLC is looking for a BioEngineer with Vaccine Management Analyst / Regulatory expertise to provide program support for our government client, the Medical Countermeasures Systems (JPM MCS) at Fort Detrick, MD. In this role you will analyze vaccine data, assess and monitor risks, and handle communication between program logistics and product development. Internally this position is a Bioengineer III.
This role is critical to our current pandemic efforts in helping to make supply and logistics decisions based on data that is accurate and up-to-date. Your business acumen, government regulatory experience, and scientific background, will be key to success in this position.
This role is critical in helping to make supply and logistics decisions based on data that is accurate and up-to-date. Your business acumen, along with your scientific background, will be key to success in this position.
A Secret Clearance is required.
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.
Duties for this role
- Shall possess five (5) years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).
- 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.
- Qualified applicant shall possess extensive customer support/relations experience with strong interpersonal contacts to increase effective team dynamics; communicate ideas, requirements, and scientific knowledge across and within organizations united for the Development of Medical Countermeasures
- Applicant shall possess five (5) years of working experience with Microsoft Office Suite, to include Outlook, Project, PowerPoint, Excel, and Word.
Education, Certifications Required
- The contractor shall possess a master’s degree in Engineering, Physics, Chemistry, Biology, Engineering Management, or a related discipline,
- (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 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.
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
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