The Director/Senior Director of Veterinary Regulatory Affairs will be responsible for overseeing the preparation and submission of regulatory applications, reports, and correspondence related to veterinary products, animal health drugs, and agricultural medicines, specifically within the scope of the FDA’s Center for Veterinary Medicine (CVM). This position will work closely with the FDA-CVM and other regulatory bodies to ensure full compliance with FDA standards for veterinary drugs and animal health products. The role will report directly to the Chief Regulatory Officer.

Independently develop, validate, and oversee the performance of testing methods designed to characterize cell-based therapeutic products at various stages of product development. Perform release and stability testing on GMP and non-GMP biologic therapeutic products for both human and veterinary programs.

Requirements:

• A bachelor’s degree in chemistry, biology or a related field, and a minimum of five years of GMP manufacturing and/or GMP laboratory industry experience are required.
• An equivalent combination of a graduate degree and experience sufficient to successfully perform the job duties as listed above is acceptable.

The Analytical Development Research Associate will contribute to analytical method development, implementation, and pre-qualification of methods focused on Rion’s exosome technology. This role will work closely with Rion Quality Control to execute method transfers and support continuous improvement. As such, the candidate will possess the technical skills required to conduct experiments and assays in a wet lab environment involving techniques such as mammalian cell culture, ELISA, RT-qPCR, HPLC and colorimetric/fluorometric-based assays. The Analytical Development Research Associate will be responsible for the execution of experiments, as well as data interpretation and final reporting. The position affords the opportunity to serve as a key member of Rion’s scientific team and contribute to the advancement of exosome therapeutics. The Analytical Development Research Associate will work closely with the Analytical Development Scientists and support the efforts of Quality Control/Process Development. As such, the successful candidate will work in an upbeat, highly collaborative and dynamic environment. Additional responsibilities associated with this position will involve assisting in day-to-day laboratory operations such as inventory management, procurement, and general laboratory and equipment maintenance.

Requirements: