Job Description

Overview

We are seeking a Scientific Program Manager to support the National Institutes of Health’s (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member. Accelerate your career and apply below to help us make a difference.

CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today’s most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs.

Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

Responsibilities

• 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 (NCT06905275) and HVTN 321 (NCT06919016).
• 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.

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.
• Experience with GMP and FDA regulations.
• Experience reviewing Certificates of Analysis/Compliance, MSDS, and stability results.
• Experience with clinical research materials and human safety.

Physical Requirements:

The physical requirements described here are representative of those that must be met by a candidate to perform the essential functions of this job. Reasonable accommodations may be provided to enable individuals with disabilities to perform essential job functions.

• Constantly required to handle sedentary work that primarily involves sitting/standing.
• Occasionally required to perform light work that includes moving objects up to 20 pounds, and medium work that includes moving objects up to 50 pounds.
• Occasionally will push or pull less than 25 pounds, push or pull 25 – 45 pounds, and reach above shoulder level.
• Constantly will use both hands.
• Occasionally stand or walk for more than 25 minutes, and bend, reach or twist repeatedly.
• Constantly required to have clear vision (near and/or far), depth perception, peripheral vision and/or visual acuity.
• Constantly required to communicate with others to exchange information.
• Constantly required to assess the accuracy, neatness and thoroughness of the work assigned.
• Occasionally required to work in noisy environments.
• Constantly required to able to wear personal protective equipment (PPE), including but not limited to gloves, face shields/goggles, safety glasses, safety shoes, lab coats, and disposable dust/surgical mask.
• Constantly will come in contact with chemicals, such as aerosols, biological inhalants, plastics, inorganic dust and powders, etc.

Please submit your resume online at . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.

Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.

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