Position Summary:

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.

Responsibilities:

• Independently design and execute studies in a wet lab setting involving mammalian cell culture,

flow cytometry, ELISA, Western blotting, RT-qPCR, and fluorometric/colorimetric-based assays

• Perform analytical method development, pre-validation, and validation work in accordance with regulatory guidance (ex. FDA Guidance Documents, ICH M10, ICH Q2(R2) and ICH Q14).

• Collaborate with Rion’s Quality Control Laboratory to execute method transfers

• Manage relationships with external organizations and contract laboratories

• Identify, evaluate, and test new analytical equipment

• Analyze, interpret, and prepare data for reporting and presentation

• Generate comprehensive summary reports and/or presentations

• Maintain GDP compliance appropriate for preclinical study execution including completion of all prescribed training and adherence to SOPs

• Continually improve processes via creation/review of SOPs, Forms, and Analytical Procedures

• Support peers and serve as a knowledge resource in a collaborative environment

• Remain up to date with current scientific literature with an emphasis on extracellular vesicle (EV) therapeutics and associated analytical methods

Qualifications:

• Ph.D. with 2+ years or M.S. with 7+ years of analytical development work experience

• Experience working in GMP laboratory environment

• In-depth understanding of regulatory guidance governing analytical method development and validation (ex. FDA Guidance Documents, ICH M10, 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

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 and continues to grow within the Rochester biotechnology ecosystem. 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 addresses significant unmet patient needs in many fields of medicine, and we are actively pursuing clinical programs in wound healing, cardiovascular diseases, musculoskeletal diseases, and pulmonary indications. Our ultimate mission is to deliver cutting edge solutions accessible to any patient in need, anywhere in the world. Position 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 their goals both at work and in their personal lives. We provide a highly competitive compensation package with a unique culture focusing on the development and wellbeing of our team.

Below are some of the benefits offered by Rion:

• Comprehensive benefits package

• Health Insurance including PPO or High Deductible Health Plan with Health Savings Account

• Dental Insurance

• Vision Insurance

• Flexible Spending Accounts (FSA)

• 401K or IRA Retirement Savings

• Life Insurance basic life and supplemental life insurance options for self, spouse, children

• Short and Long-Term Disability Insurance

• Discretionary Time Off

• Paid Holidays

• Parking benefits

Rion is an equal opportunity employer and 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.