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

As a Specialist in the Quality Assurance department, this position plays a key role in ensuring our products meet all requirements. This position will integrate with internal development, manufacturing, and laboratory functions as well as external contract manufacturers and laboratories. This individual will have the opportunity to grow and expand responsibilities as Rion advances through stages of development.

Job Responsibilities:

Provide Quality Assurance support of GMP product manufacturing and development of human and veterinary products, including:

• Review of and support of the creation and approval of manufacturing documentation, e.g. master batch records, risk assessments, and equipment qualifications.
• Creating and revising standard operating procedures supporting the quality system
• Reviewing executed batch records and dispositioning materials for clinical and commercial use
• Review/approval of facilities/equipment/process validation protocols and reports
• Quality lead in working with contract manufacturing and testing organizations providing services to Rion
• Supporting development protocols and reports
• Provide Quality Assurance support of GMP laboratory, including:
• Performing data review of executed laboratory analyses         
• Issuing controlled analytical forms and laboratory notebooks
• Review of certificates of analysis / test
• Participate, oversee, and approve of quality events such as complaints, deviations, change controls, and laboratory investigations.
• Support ongoing improvements in Rion’s quality system and overall compliance to regulations

Qualifications

• A bachelor’s degree in chemistry, biology or a related field, and a minimum of seven 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.

Additional Information

• Schedule: Monday – Friday
• Work Location: Rochester, MN
• Work Remotely: Yes
• Relocation Assistance: No
• Job Type: Full-time, Exempt
• Direct Reports: 0+
• Travel: 10% or as needed

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

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

As a Specialist in the Quality Assurance department, this position plays a key role in ensuring our products meet all requirements. This position will integrate with internal development, manufacturing, and laboratory functions as well as external contract manufacturers and laboratories. This individual will have the opportunity to grow and expand responsibilities as Rion advances through stages of development.

Job Responsibilities:

Provide Quality Assurance support of GMP product manufacturing and development of human and veterinary products, including:

• Review of and support of the creation and approval of manufacturing documentation, e.g. master batch records, risk assessments, and equipment qualifications.
• Creating and revising standard operating procedures supporting the quality system
• Reviewing executed batch records and dispositioning materials for clinical and commercial use
• Review/approval of facilities/equipment/process validation protocols and reports
• Quality lead in working with contract manufacturing and testing organizations providing services to Rion
• Supporting development protocols and reports
• Provide Quality Assurance support of GMP laboratory, including:     
• Performing data review of executed laboratory analyses
• Issuing controlled analytical forms and laboratory notebooks
• Review of certificates of analysis / test
• Participate, oversee, and approve of quality events such as complaints, deviations, change controls, and laboratory investigations.
• Support ongoing improvements in Rion’s quality system and overall compliance to regulations

Qualifications

• A bachelor’s degree in chemistry, biology or a related field, and a minimum of seven 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.

Additional Information

• Schedule: Monday – Friday
• Work Location: Rochester, MN
• Work Remotely: No
• Relocation Assistance: Yes
• Job Type: Full-time, Exempt
• Direct Reports: 0+

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 or IRA Retirement Savings Plan
• Life Insurance Programs
• Basic life and supplemental life insurance options for self, spouse, children
• Short and Long-Term Disability Insurance
• Paid 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

About Rion

Rion is a clinical-stage biotechnology company based in Rochester, Minnesota, founded through the Mayo Clinic Employee Entrepreneurial Program. Our mission is to develop clinically impactful and accessible therapies using innovative regenerative medicine technologies based on extracellular vesicle science. Rion’s proprietary exosome platform aims to address significant unmet patient needs across multiple therapeutic areas, including wound healing, cardiovascular disease, and musculoskeletal diseases.

Position Summary

As a Specialist in the Quality Assurance department, this position plays a key role in ensuring our products meet all requirements. This position will integrate with internal manufacturing and laboratory functions as well as external contract packagers. This individual will have the opportunity to grow and expand responsibilities as does our company as Rion advances through stages of development.  

Job Responsibilities:

Provide Quality Assurance support of GMP product manufacturing and development, including: 

• Maintaining master batch records and material inspection plans 
• Creating and revising standard operating procedures
• Issuing production records
• Reviewing executed batch records and dispositioning materials
• Working with contract manufacturers that package Rion products
• Supporting development protocols and reports

Provide Quality Assurance support of GMP laboratory, including:

• Performing data review of executed laboratory analyses
• Creating and revising standard operating procedures
• Issuing sample data packets and laboratory notebooks
• Issuing Certificates of analysis 

• Oversee the document control room and retention of GMP documentation
• Perform investigations on customer complaints and support deviations, change controls, and laboratory investigations 

Qualifications:

• 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.
• Equivalent combination of a graduate degree and experience sufficient to successfully perform the job duties as listed above is acceptable.

Additional Information:

• Schedule: Monday – Friday
• Work Location: Rochester, MN
• Work Remotely: No
• Relocation Assistance: Yes
• Job Type: Full-time, Exempt
• Direct Reports: 0+

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

About Rion

Rion is a clinical-stage biotechnology company based in Rochester, Minnesota, founded through the Mayo Clinic Employee Entrepreneurial Program. Our mission is to develop clinically impactful and accessible therapies using innovative regenerative medicine technologies based on extracellular vesicle science. Rion’s proprietary exosome platform aims to address significant unmet patient needs across multiple therapeutic areas, including wound healing, cardiovascular disease, and musculoskeletal diseases.

Position Summary

Independently develop, validate, and oversee the performance of testing methods in a GMP QC lab 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.

Job Responsibilities:

• Assist with management of the QC group including test scheduling and supervision of division and corporate goal completion
• Oversee transfer of developed human and veterinary assays for biological drug product into QC laboratory
• Validate and qualify human and veterinary biological drug product analytical assays in QC in accordance with ICH Q2(R2)
• Perform analytical testing (e.g. molecular diagnostics, protein expression, bioassays, and particle analysis, cell-based potency assays) of GMP and non-GMP product samples.
• Maintain required documentation according to departmental policy to support product release and process development, following GMP documentation
• Write SOP ‘s, analytical procedures, cell banking batch records and other required documents to support product testing following internal and regulatory requirements.
• Independently design and implement method validations for release testing in the QC lab to satisfy internal and regulatory requirements.
• Develop and maintain knowledge of regulatory requirements (i.e. FDA, ICH, EMA, CVM issued guidance, ISO, USP and others) and product-related scientific literature.
• Monitor and trend Quality Control testing data to assure validity of test system results. Troubleshoot experiments and test systems as needed.
• Oversee analysis of data and report results. Advise internal customers regarding outcomes of testing.
• Maintain instrumentation. Monitor instrument performance to assure optimal operation. Help with design and performance of Performance Qualifications.
• Support the registration of the Quality Control lab with FEI number and associated quality control/quality assurance milestones
• Perform and oversee biologic drug product characterization testing in support of research, process development and manufacturing efforts
• Write stability programs for biologic therapeutic products

Qualifications:

• Ph.D in life sciences discipline with 4-5 years industry experience
• M.S. with >5 years industry experience
• B.S. with >10 years industry experience
• Equivalent combination of a graduate degree and experience sufficient to successfully perform the job duties as listed above is acceptable.
• Experience working in a GMP or regulated laboratory environment is a requirement
• Experience working in QC for Biological Drug Products is a requirement
• Training in regulatory compliance for drug product stability and release testing, with organizations such as CFPIE
• Experience with veterinary products is preferred
• Knowledge of CVM requirements for QC assays

Additional Information:

• Schedule: Monday – Friday
• Work Location: Rochester, MN
• Work Remotely: No
• Relocation Assistance: Yes
• Job Type: Full-time, Exempt
• Direct Reports: 0+

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.

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Relocation assistance
• Retirement plan
• Vision insurance

Education:

• Doctorate (Preferred)

Experience:

• GMP : 1 year (Required)
• QC for Biological Drug Products: 1 year (Required)

Ability to Relocate:

• Rochester, MN 55902: Relocate with an employer provided relocation package (Required)

Position Description

Location: On-Site – Rochester, Minnesota

Department: Facilities

Reports to: Director of Facilities and Engineering  

Company Overview:

Rion is a 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 ultimate mission is to deliver cutting edge solutions accessible to any patient in need, anywhere in the world.

Position Summary:

The Industrial Maintenance Mechanic is responsible for the installation, maintenance, troubleshooting, and repair of production and facility equipment used in manufacturing. This role ensures optimal performance, safety, and compliance of critical systems including lyophilizers, mixers, HVAC systems, and industrial freezers.

Job Responsibilities:

• Perform preventive, predictive, and corrective maintenance on manufacturing and facility equipment
• Troubleshoot and repair mechanical, pneumatic, and basic electrical issues on:
  • Lyophilizes (freeze dryers)
  • Mixing and blending equipment
  • HVAC systems (air handling units, chillers, ducting)
  • Industrial freezers and refrigeration systems
• Support production by responding quickly to equipment breakdowns and minimizing downtime
• Calibrate and maintain equipment to ensure compliance with GMP (Good Manufacturing Practices) standards
• Assist in equipment installation, commissioning, and validation activities
• Read and interpret technical manuals, blueprints, and schematics
• Maintain accurate maintenance logs, work orders, and documentation
• Collaborate with engineering and quality teams to improve equipment reliability and performance
• Ensure adherence to safety procedures, including LOTO (Lockout/Tagout) and OSHA standards

Qualifications

• High school diploma or GED (technical certification or trade school preferred)
• 10+ years of maintenance experience in manufacturing (cosmetic, pharmaceutical, or food industry preferred)

Preferred Qualifications / Skills

• Strong working knowledge of:
  • Mechanical systems and components
  • Industrial refrigeration and HVAC systems
  • Pumps, valves, motors, and gearboxes
• Experience with lyophilization and mixing equipment strongly preferred
• Basic understanding of electrical systems (motors, sensors, control panels)
• Ability to use hand tools, power tools, and diagnostic equipment
• Strong troubleshooting and problem-solving skills
• Attention to detail and commitment to quality
• Ability to work independently and in a team environment
• Good communication and documentation skills
• Ability to prioritize tasks in a fast-paced production environment
• Experience working in GMP-regulated environments
• Certification in HVAC, refrigeration, or industrial maintenance
• Familiarity with PLC-controlled equipment (troubleshooting level)
• Knowledge of sanitation and hygienic design standards

Work Environment

• Manufacturing facility with exposure to moving machinery, temperature-controlled areas, and noise
• May require lifting up to 50 lbs., standing for extended periods, and working in confined spaces
• Flexible schedule may be required, including weekends or on-call support

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 highly competitive compensation package with a unique culture focusing on the development and wellbeing of our staff. Below are some of the benefits offered by Rion:

• Comprehensive benefits package including company equity
• 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
• Paid Parental Leave
• Paid 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.