Janie Russell
About Janie Russell
Janie Russell is a biologist with extensive experience in regulatory submissions to the FDA, focusing on biologics, vaccines, and drugs for infectious diseases. She conducts audits and evaluates manufacturing and testing processes to ensure compliance with regulatory standards.
Work at National Institutes of Health
Janie Russell has extensive experience in the field of biology, particularly in regulatory submissions to the FDA. Her work focuses on biologics, vaccines, and drugs that target infectious diseases. She conducts audits of manufacturing, testing, and non-clinical studies to ensure compliance with regulatory standards. This role involves reviewing and evaluating manufacturing and testing processes for biological materials and small molecules throughout the pre-clinical to clinical trial stages.
Education and Expertise
Janie Russell studied at Salisbury University, where she earned a Bachelor of Science (BS) in Biology from 1982 to 1984. She furthered her education at Hood College, specializing in Regulatory Studies. Her academic background provides a solid foundation for her expertise in regulatory affairs and biological research.
Background
Janie Russell has built a career centered around the intersection of biology and regulatory compliance. Her experience encompasses a range of responsibilities, including study design and report evaluation for both non-clinical and clinical studies. This background equips her with the necessary skills to navigate complex regulatory environments.
Achievements
Janie Russell's professional achievements include her role in regulatory submissions for biologics, vaccines, and drugs aimed at infectious diseases. She has contributed to ensuring compliance in manufacturing and testing processes, which is critical for the advancement of medical products. Her involvement in study design and evaluation further highlights her contributions to the field.