Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Scientific Program Manager to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS), Vaccine Research Program (VRP), Vaccine Translational Research Branch (VTB), Rockville, MD.
- Work with federal staff responsible for GMP product development of vaccines for infectious diseases including the production of investigational products that are identified as strong candidates to move from a preclinical to clinical phase.
- Participate as a team member in a group composed of different staffing areas including scientific/technical roles, project management, regulatory affairs, quality assurance, contracts and finance. Activities include participating in both the development of vaccines and adjuvants, assisting in the authoring the Chemistry, Manufacturing and Controls and Toxicology sections of Investigational New Drug submissions, providing protocol and Investigator Brochure review, and assisting in providing oversight of Contract Manufacturing Organizations.
- Assist in the evaluation and propose appropriate toxicity studies and models for products intended to be studied as vaccines.
- Coordinate with Quality, Regulatory and Technical team members for health regulatory compliance.
- Provide regulatory advice and recommendations to the Project Lead for manufacturing projects and pre-clinical studies.
- Assist the team with impact/risk assessment from issues, failures and deviations during manufacturing and pre-clinical studies.
- Prepare technical reports, updates and summaries for internal meetings with Division Management.
- Perform site-visits of CMOs at kick-off or during critical project execution stages or for troubleshooting as requested by the POC.
- Review, GMP manufacturing batch records, SOPS, deviation reports, etc.
- Participate with Team members to track product stability reports with respect to stability timepoints, review the product stability protocol for consistency and completeness, ensure that the stability program matches the requirement per the project Statement of Work, review stability Certificate of Analysis and/or Stability reports/data for out of specification testing results, issue the Shelf-Life Extension document after reviewing of the stability report.
- Assist in the preparation and review of regulatory documents including pre-IND materials, and IND, as required.
- Prepare oral and written presentations for internal and external programmatic and scientific meetings.
- Participate in on site audits of vendors.
- Paid Time Off (PTO)
- 10 Paid Federal holidays
- Generous health coverage provided with no monthly premium to the employee
- Generous vision and dental coverage provided with no monthly premium to the employee
- Short and Long-Term Disability coverage (paid by company)
- Basic Life and AD&D coverage (paid by company; option to purchase additional coverage)
- 401(K) with significant company match & no vesting period
- Competitive salaries with performance bonus opportunities
- Discount plan for pet care, legal services, & identify theft protection
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact:
Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.