Scientific Program Manager
Scientific Program Manager
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Job Description
(ID: 2025-0392)
Axle 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).
Benefits:
- 100% Medical Dental & Vision Coverage for Employees
- Paid Time Off (Including Holidays)
- Employee Referral Bonus
- 401K Match
- Tuition reimbursement and professional development opportunities
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
Overview
Axle is looking to add a driven flexible organized and meticulous Scientific Program Managerto our dynamic team. The Contractor(s) shall provide services in support of the overall functions of the Vaccine Translational Research Branch (VTRB) Vaccine Research Program (VRP) Division of AIDS (DAIDS) National Institute of Allergy and Infectious Diseases (NIAID).
Technical Requirements:
- Verify that vendor and contract manufacturers follow FDA 21 CFR 210/211 cGMP promptly address any gap and document the outcome so only fully compliant products are introduced into NIH-sponsored trials.
- Provide critical oversight of clinical research materials & human safety by ensuring investigational drugs and biologics remain safe for NIH sponsored clinical trials such as HVTN 319 (NCT) and HVTN 321 (NCT).
- Continuously review Certificates of Analysis/Compliance MSDS and stability results to detect out-of-specification trends early. Initiate corrective actions and withhold any lot that could potentially endanger participants.
- Interpret each stability time-point against protocol and ICH Q1 guidelines to confirm ongoing safety potency and purity. Escalate deviations immediately and recommend shelf-life extensions only when scientific data support no risk to volunteers.
- Disposition investigational drug products after temperature excursions or other integrity breaches to ensure compromised material is quarantined investigated and if necessary destroyed.
- Track clinical material shipments verify cold chain integrity in transit and reconcile inventory in real time so no unverified lot reaches a clinical site.
- Maintain live inventory data prevent distribution of lots with unresolved quality issues and confirm that quantities expiry and storage conditions align with clinical trial needs and FDA regulations.
- Capture oversight actions in an auditable record to demonstrate adherence to FDA NIH and DAIDS requirements and to support inspections.
- Prepare and critically review Pre-IND packages Type B meeting requests IND submissions and clinical-hold responses ensuring all quality-risk mitigations are clearly
presented to FDA. - Map VTRB product oversight processes author and update SOPs and deliver training that embeds cGMP and human-subject safety principles across the branch.
- Other duties as assigned to advance the primary mission of protecting human subjects and ensuring FDA cGMP compliance.
Specific Qualifications:
- PMP certification and experience in managing cGMP of biologics is preferred
- M.S. degree in biochemistry or biology or equivalent education and at least 8 years of experience in industry or B.S. degree in biochemistry or biology or equivalent education and at least 10 years of experience in industry is required.
The diversity of Axles 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 individuals 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.
This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidates experience qualifications skills and location.
#INDPSD
Salary Range
$120000 - $140000 USD
Required Experience:
Manager
Employment Type
Full Time
