CAMRIS International is a medical research and development firm that realizes innovative solutions to health and development challenges 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 is seeking a Scientific Program Manager to support the mission of the Laboratory of Allergic Diseass (LAD) within the National Institute of Allergy and Infectious Diseases (NIAID) at The National Institutes of Health (NIH).
*This position is contingent upon contract award.
* Assist in the development of new cell lines and cell culture process development including scale-up and tech transfer functions to support and advance Vaccine Research Center clinical vaccine and therapeutic protein candidates.
* Administer process development studies using various culture approaches ranging from microtiter plates to small scale bioreactors.
* Conduct the development of platform design, optimization, and cycle-time reduction studies performed in the Vaccine Production Program laboratories
* Write and review technical reports documenting process development studies and for regulatory filings
* Conduct studies that would include expression vector design and optimization, evaluation of different culture media, and methods for clone selection, expansion, ranking, and characterization
* Conduct process development work that would follow industry standards ranging from small scale, robotic design of experiment (DOE) studies and scale up for tox lot productions
* Ph.D. in Biological Sciences with a minimum of 20 year of research and development experience in an academic or industrial setting is required. Industrial preferred.
* Hands-on experience with mammalian cell culture technology including aseptic techniques, general cell culture laboratory techniques, single cell cloning, flow cytometry, high-throughput transfection platforms, and bioreactors ranging from mini robotic scale to production scale (50L at least) is required
* Must have experience with vector design and molecular coloning methods
* Additional experience in alternative mammalian and microbial protein expression systems for production of vaccine components and products is highly desirable
* Must have knowledge of cGMP requirements for cell line creation and support of regulatory filings