We are seeking a full-time Manager of Regulatory Affairs. The Regulatory Affairs Manager 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 5 years of health regulated industry experience OR (B) a master level degree plus 4 years of health regulated industry experience.
• A degree in a scientific discipline is preferred.
• Basic knowledge of the drug development process and 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.
• Experience responding to FDA requests and interacting with FDA is required.
• Experience of lifecycle management of IND/BLA applications is required.
• Demonstrated experience in critically reviewing and compiling regulatory documents is required.
• Previous biological or pharmaceutical Regulatory experience is a plus.
• A proven ability to work successfully within a reciprocal team environment as an individual contributor and decision maker within a cross-functional organization is required.
• The ability to effectively prioritize assignments for multiple products and projects simultaneously is required.
• Strong interpersonal and communication skills

All resumes can be sent to careers@riontx.com.

We are seeking a full-time Analytical Development Scientist at Rion Inc., located in Rochester, MN. The Analytical Development Scientist will lead assay development and validation projects designed to test biologic drug products. The individual will be a key member of Rion’s scientific team and work closely with Research Scientists, Quality Control, Process Development, and Regulatory Affairs. The applicant should be a highly motivated and scientifically independent individual with the ability to lead cross-functional projects and communicate effectively with the broader Rion team.

Qualifications:
• Ph.D. with 2+ years or M.S. with 7+ years of analytical development work experience
• Proficiency in GLP and GDP regulations
• In-depth understanding of regulatory guidance governing analytical method development and validation (ex. FDA Guidance Documents, ICH Q2(R2) and ICH 14).
• Demonstrated expertise in analytical method development and validation.
• Experience with wet lab bioassays including mammalian cell culture, flow cytometry, ELISA, Western blotting, RT-qPCR, and fluorometric/colorimetric-based assays.
• Proficient in data analysis and graphical software (ex. Microsoft Excel, GraphPad Prism)
• Excellent written and verbal communication skills
• Ability to present findings to individuals outside of R&D Department
• Strong organizational and time management skills
• Attention to detail with an ability to perform critical review of various types of documents.
• Ability to independently design studies, solve problems, interpret data, and draft reports.
• Demonstrated ability to work as a team player with multi-disciplinary project teams.

All resumes can be sent to careers@riontx.com.