Job Description

Overview

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices.

Summary:

Goldbelt Apex LLC is seeking a qualified Scientist IV to support our Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear (JPEO-CBRND) Joint Project Manager for Medical Countermeasure Systems (JPM MCS) client at our Ft. Detrick, MD location. This position requires an active Secret clearance. You must be a U.S. citizen.

Responsibilities

Essential Job Functions:

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.

Qualifications

Necessary Skills and Knowledge:

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.

Minimum Qualifications:

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: 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.
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.
Ten (10) years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).
Five (5) years of experience in pre-clinical and clinical drugs, vaccines, biologics, assays, or diagnostics advanced development (IND to FDA licensure).
Senior-level DoD experience in pharmaceutical/biotechnology vaccine and drug development portfolio management (i.e., investment decisions based on the risk management process).
Five (5) years of working experience with Microsoft Office, to include Outlook, Project, PowerPoint, Excel, and Word.
Only candidates eligible for a Secret level clearance will be considered (US Citizenship required).

Preferred Qualifications:

Active Secret clearance preferred

The salary range for this position is $120,000 to $145,000 per year.

Pay and Benefits
At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.

About Goldbelt, Inc.

Learn More About Goldbelt, Inc.

Goldbelt, Inc. Careers

Joining Goldbelt, Inc. presents a prime opportunity to be part of a team that values innovation, leadership, and diversity. As a recognized leader in providing innovative solutions, Goldbelt, Inc. offers a variety of job opportunities that cater to professionals seeking growth and development in their careers.

Explore Career Opportunities

Goldbelt, Inc. is actively hiring and offers a range of positions that suit different skills and career aspirations. From internships that provide real-world experience to full-time positions that challenge and expand professional capabilities, Goldbelt, Inc. ensures that every team member can find a path that suits their career goals.

Professional Growth and Development

Goldbelt, Inc. is committed to the professional growth of its employees. With comprehensive training programs and leadership development opportunities, employees are equipped to take on leadership roles within the company. The emphasis on continuous learning and development ensures that every employee has the tools needed to succeed and innovate within their field.

Diversity and Inclusion

At Goldbelt, Inc., diversity is more than just a buzzword. The company fosters an inclusive culture where diverse perspectives are valued and contribute to the company's success. Diversity training programs are integral, ensuring that all team members understand and appreciate the strength that lies in differences.

Benefits and Culture

The benefits at Goldbelt, Inc. go beyond standard employment perks. Employees enjoy a supportive culture that promotes work-life balance, alongside benefits that cater to both personal and professional needs. This supportive environment ensures that employees feel valued and motivated to contribute their best work.

Networking and Career Advancement

Goldbelt, Inc. encourages networking within the industry, providing employees with numerous opportunities to connect with peers and leaders who can influence their career trajectory. These connections are vital for professional development and can lead to new opportunities within the company.

Applying for a Position

To apply for a position at Goldbelt, Inc., candidates are encouraged to submit a resume that highlights relevant experience and skills. The interview process is designed to assess not only professional qualifications but also a candidate's fit within the company culture and their potential to contribute to the team’s success.

Stay Connected with Goldbelt, Inc. Careers

Interested candidates can stay updated on new job opportunities and company news by subscribing to job alert emails. This personalized subscription keeps potential applicants informed about positions that match their skills and career interests.

Join Goldbelt, Inc.

Explore the career opportunities at Goldbelt, Inc. and discover how joining this team can enhance professional skills, foster personal growth, and provide a rewarding career path in a dynamic and supportive environment.