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:

Rion is seeking a Supervisor of Clinical Supply Chain and Packaging Operations to support clinical and manufacturing activities through hands on execution and cross functional coordination.

This role is a highly hands on individual contributor responsible for supporting secondary packaging, kitting, material sourcing, inventory coordination, warehouse operations, shipping logistics, and manufacturing readiness. The position will play a critical role in ensuring materials, equipment, and kits are available, organized, and ready to support ongoing and upcoming programs.

The ideal candidate brings experience in supply chain, manufacturing support, or packaging operations within a regulated environment and is comfortable working across multiple functions while also directly executing operational work.

Basic Qualifications

• Bachelor’s degree in supply chain, Operations, Life Sciences, Business, or related field
• Minimum 6 years of relevant experience in supply chain, logistics, or related roles
• Experience supporting or writing SOPs, protocols, or operational documentation
• Strong organizational and problem-solving skills with the ability to manage multiple priorities
• Ability to operate as a hands-on individual contributor in a fast-paced environment

Preferred Qualifications

• Experience supporting secondary packaging, kitting, or clinical materials operations
• Experience working with CMOs, CDMOs, or third-party logistics providers
• Experience with cold chain and temperature-controlled shipping
• Experience supporting manufacturing readiness
• Experience in early stage or rapidly growing organizations

The Sr. Manager Regulatory Affairs will prepare and submit regulatory agency applications, reports, or correspondence with minimal oversight and will report to the Sr. Director of Regulatory Affairs at Rion.

Qualifications:

• One of the following combinations of education and experience is required: (A) a minimum of a bachelor’s degree plus 10 years of health regulated industry experience OR (B) a master level degree plus 8 years of health regulated industry experience.
• A degree in a scientific discipline is preferred
• Knowledge of the drug development process and NDA/BLA regulatory submission and approval process is required
• Understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required
• Previous biologic or pharmaceutical regulatory experience is required
• Experience responding to FDA requests and interacting with FDA is required
• Experience with filing and lifecycle management of IND/BLA applications is required
• Experience in pharmaceutical/biologic aesthetics is preferred
• Demonstrated experience in writing, critically reviewing and compiling regulatory documents
• Proven ability to work successfully within a reciprocal team environment as an individual contributor and decision maker within a cross-functional organization
• The ability to effectively prioritize assignments for multiple products and projects simultaneously
• Strong interpersonal and communication skills