Come work with RION in the heart of downtown Rochester, a vibrant rapidly-growing city located in Southeast Minnesota. Located in the home of the number one hospital in the country, time and again, Rochester, MN, ranks among the best places to live in the United States owing to its affordable cost of living, healthy lifestyle, stellar school systems, and exceptional quality of life. Rochester is also well known as a global destination for health and wellness. For the past decade, state officials in collaboration with the Mayo Clinic and City of Rochester, have implemented Destination Medical Center, a 20-year, $5.6 billion economic development initiative focused on developing Rochester as a global epicenter for life sciences and healthcare innovation. Utilizing public and private investments, Rochester is creating an inviting ecosystem for biotechnology start-up ventures looking to capitalize on a skilled and educated workforce.

MISSION AND VISION

Re-Imagining Medicine We seek to change the approach to regenerative medicine by utilizing exosome technology to improve the lives of more patients, in more places, across more diseases, from every walk of life. Senior analyst, Quality control About Rion Rion is a clinical-stage biotechnology company based in Rochester, Minnesota. Rion was founded as a Mayo Clinic Employee Entrepreneurial Program startup company. Rion's mission is to develop clinically impactful and accessible therapies using innovative regenerative medicine technologies based on extracellular vesicle science. Our proprietary exosome platform has the ability to address significant unmet patient needs in many fields of medicine; accordingly, we are actively pursuing clinical programs in wound healing, cardiovascular diseases, and women's health. Our ultimate mission is to deliver cutting edge solutions accessible to any patient in need, anywhere in the world. Position Summary The Senior Analyst will execute analytical and bench-level testing in a GMP Quality Control laboratory supporting the release, stability, and characterization of cell- and exosome-based therapeutic products. Accurately document and trend testing data, support method transfers and lifecycle activities, and contribute to investigations under the guidance of QC leadership. This role reports to a Senior Scientist, Quality Control and does not carry direct reports. The Senior Analyst will also work closely with Analytical Development and Quality Assurance to ensure cross-functional alignment and compliance is maintained.

Job Responsibilities:

Perform analytical testing (e.g., molecular diagnostics, protein expression, bioassays, nanoparticle analysis, and mammalian cell-based potency assays) on GMP and non-GMP product samples in accordance with approved procedures Execute release and stability testing for final drug products, ensuring accurate and timely completion within established timelines Accurately record, review, and maintain testing documentation in accordance with GMP documentation practices and departmental policy Trend Quality Control testing data (e.g., assay controls, instrument performance, environmental monitoring) to help identify shifts, drifts, or out-of-trend results, and escalate findings to senior staff Support laboratory investigations, including OOS/OOT results and deviations, by gathering data, executing troubleshooting experiments, and documenting findings Participate in method transfer activities for analytical assays moving into or within the QC laboratory Support method lifecycle management activities, including periodic method review, minor method changes, and comparability assessments, under the direction of a Senior Scientist Troubleshoot routine assay and instrument performance issues, escalating complex issues to Senior Scientist or QC leadership as needed Maintain laboratory instrumentation, including routine calibration, maintenance, and use logs, to ensure optimal and compliant operation Author and revise SOPs, test methods, and other controlled documents as assigned Maintain working knowledge of applicable regulatory requirements (e.g., FDA, ICH, CVM, USP) as they relate to assigned testing responsibilities Support general laboratory operations, including reagent and supply management, inventory tracking, and maintenance of a clean and compliant lab environment

Skills:

Demonstrated industry knowledge of cGMP Strong communications skills: a team player who collaborates on complex projects Experience participating and/or supporting regulatory inspections required

Qualifications:

BS. or equivalent in a life sciences discipline with 3+ years of industry experience in a regulated QC laboratory Experience working in a GMP or other regulated laboratory environment is a requirement Hands-on bench experience with analytical or bioassay techniques relevant to biologic drug products (e.g., ELISA, flow cytometry, qPCR, cell-based assays, particle analysis) is a requirement Experience supporting laboratory investigations, deviations, or CAPAs is preferred Experience with method transfer or method validation activities is preferred Strong attention to detail and documentation practices consistent with GMP expectations

Additional Information Schedule:

Monday -

Friday Work Location:

Rochester, MN Work Remotely:

No Job Type:

Full-time The Benefits Rion recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue career path their goals, both at work and in their personal lives. We provide a competitive compensation package with a unique culture focusing on development and wellbeing of our staff. Below are some of the benefits offered by

Rion:

Full Health, Dental and Vision Insurance for employees and their dependents. Choice between PPO or High Deductible Health Plan with Health Savings Account (HSA) Flexible Spending Accounts (FSA) 401K Retirement Savings Plan Life Insurance Programs Basic life and supplemental life insurance options for self, spouse, children Short and Long-Term Disability Insurance Discretionary Time-off, Paid Holidays, and Parental Leave programs Parking Benefits EEO Statement Rion is proud to be an equal opportunity employer that complies with all applicable federal, state and local fair employment practices laws. Rion strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law. Recruitment & Staffing Agencies Rion does not accept agency resumes unless contacted directly by internal Rion Talent Acquisition. Please do not forward resumes to Rion employees, or any other company locations; Rion is not responsible for any fees related to unsolicited resumes. All resumes can be sent to careers@riontx.com Our Perks Health Insurance Dental Insurance Vision Insurance Flexible Spending Accounts (FSA) 401K or IRA Retirement Savings Supplemental Life Insurance Short and Long-Term Disability Insurance Paid Family Leave Paid Time Off Paid Holidays Parking Benefits Health Insurance Dental Insurance Vision Insurance Flexible Spending Accounts (FSA) 401K or IRA Retirement Savings Supplemental Life Insurance Short and Long-Term Disability Insurance Paid Family Leave Paid Time Off Paid Holidays Parking Benefits

EEO STATEMENT RION

is proud to be an equal opportunity employer that complies with all applicable federal, state and local fair employment practices laws. RION strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

RECRUITMENT & STAFFING AGENCIES RION

does not accept agency resumes unless contacted directly by internal RION Talent Acquisition. Please do not forward resumes to RION employees, or any other company locations; RION is not responsible for any fees related to unsolicited resumes.