Scientific Program Manager
Camris International

Overview

CAMRIS is a clinical and life sciences firm that realizes innovative solutions to challenges worldwide through high-quality, cost-effective program and research management services. We combine our proven systems with today's most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.

CAMRIS attracts the next generation of scientists to work at premier government research and development institutions with state-of-the-art facilities and equipment, under world leaders in health research. Our exceptional benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, and life insurance. If you enjoy being a part of a high performing health and research organization dedicated to making the world a healthier place, please apply today!

We are seeking a Scientific Program Manager in support of the overall functions of the Cellular Immunology Section.

Responsibilities

• Participate in monthly calls on the Malaria L9LS study to review the progress.
• Review the protocol prior to scientific review of the Malaria L9LS study.
• Develop regulatory strategies appropriate for manufacturing clinical products for Phase I, II, and III trials, e.g., planning, reviewing, and overseeing manufacturing methods, toxicology protocols, and preclinical packages.
• Make recommendations regarding alternative serotypes for adenoviral vector vaccine candidates, and assessments of direct viral load and viral immunology studies in concert with VRC researchers.
• Responsible for chemistry, manufacturing, and controls (CMC) of all investigational new drug (IND) applications for vaccines and related products and oversee the planning, preparation, and review of IND materials to ensure compliance with FDA guidelines and the Code of Federal Regulations (CFR).
• Provide expertise for testing and characterizing strategies for cell substrates, vaccine constructs, and vaccine formulation.
• Responsible for assembling all CMC IND packages for integration and submission to regulatory authorities by other intramural or extramural agencies.

Qualifications

• Bachelor's degree with seven (7) to ten (10) years of related experience OR Master's degree with five (5) to seven (7) years of related experience is required.
• Project management skills and ability to synthesize project workloads is required.

CAMRIS International, LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at CAMRIS.com . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

Full vaccination against COVID-19, defined as two doses of Moderna, two doses of Pfizer, or one dose of Johnson & Johnson's Janssen, is required for this position.