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)

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

Reporting to the VP of Program & Alliance Management, the Associate Director of Program & Alliance Management is a primary partner‑facing role responsible for execution and oversight of partnered programs and partner relationships. The Associate Director will drive alignment and accountability across internal cross-functional teams while fostering strong, transparent partner relationships through ownership of program execution, partner communications, scope/schedule/cost management, and proactive issue escalation, as appropriate.

Alliance Management Key Responsibilities

Partnered Program Leadership & Execution

• Lead integrated joint program planning efforts
• Lead program execution with minimal oversight, anticipating downstream impacts to manufacturing, quality, and regulatory deliverables, as well as commitments made to partners
• Drive alignment between contractual scope and operational execution; ensure programs are executed in alignment with approved scope, schedule, and quality requirements
• Lead joint internal/partner escalation discussions and provide executive‑level updates

Partner Alliance & Relationship Management

• Serve as a partner advocate for internal budget, resource and prioritization efforts
• Build and maintain strong, trust‑based relationships with partner teams and leadership
• Manage partner expectations through transparent communication of risks and mitigation options and impact
• Support partner satisfaction through responsiveness, consistent delivery, and issue resolution

Program Management Key Responsibilities

Internal Cross‑Functional Coordination

• Translate partner objectives, detailed in scopes of work (SOWs), into actionable internal workplans with clear ownership and accountability
• Drive alignment across Rion internal line functions, including R&D, Analytical and Process Development, GMP Manufacturing, Supply Chain, QA, QC, Clinical, and Regulatory Affairs
• Operate with a deep understanding of GMP environments, quality systems, and inspection readiness; partner with Quality to assess and communicate impacts of deviations, CAPAs, and change controls to timelines of milestone deliverables and partner commitments

Joint Program Coordination

• Create a positive team environment that instills trust, ensures clear and transparent communication, and promotes alignment on program objectives and priorities
• Lead routine joint internal/partner program meetings and focused ad-hoc meetings as necessary
• Ensure meeting minutes, action items, and decisions are documented and tracked to closure
• Develop program timelines; actively manage dependencies and constraints
• Facilitate critical decision-making within the team; identify where strategic and operational adjustments are necessary throughout development
• Drive issue identification and resolution, risk management and contingency planning
• Prepare clear, accurate program status updates for joint team members and leadership; maintain transparency regarding risks, mitigations, options, and impact to enable efficient decision-making, and appropriately escalate as necessary

Scope Contracts, Change Control, Financial Oversight

• Support development and execution of Statements of Work (SOWs) based on partner objectives and internal capabilities
• Develop (with line functions) cost projections associated with SOWs; track to actual spend
• Ensure alignment between execution and contractual obligations; generate change orders where necessary
• Partner with Finance to track program milestone completion and invoicing readiness

Measures of Success

• Strong internal collaboration and effective cross‑functional coordination
• Clear execution‑to‑contract alignment across programs
• On‑time, compliant delivery of partner program milestones
• Clear visibility of program health, risks, and milestone delivery status
• High partner satisfaction

Required Qualifications

• A minimum of 10 years of biotech/pharmaceutical industry experience with at least 5 years of relevant Project Management experience
• Strong leadership, negotiation, and conflict management skills; experience in managing projects and people in a team environment through change
• Proven track record of successfully leading complex, multi‑functional programs in GMP settings to deliverables
• Demonstrated experience coordinating cross‑functional teams in a regulated GMP environment.
• In-depth knowledge of biological drug development process with preferred experience in late-phase and commercial programs
• Strong understanding of pharmaceutical/biotech workflows, including GMP manufacturing, GMP testing, manufacturing process implementation and/or tech transfer, quality systems, clinical trial execution, and regulatory submissions
• Experience in program/project management best practices and project management tools
• Bachelor of Science degree in life sciences, engineering, or relevant to medicine, human disease, or pharmaceutical development
• Ability to travel domestically up to 20%
• Excellent communication, organization, and stakeholder relationship and management skills

Preferred Qualifications

• Direct experience working in a CMO/CDMO environment managing sponsor programs strongly preferred
• Experience managing late‑stage development, validation/PPQ, BLA-preparedness, or commercial manufacturing programs
• Familiarity with contract management, change order processes, and financial tracking
• Experience with contract structures (MSA/SOW/change orders).

Key Competencies

• Partner‑centric mindset with strong relationship‑building skills
• Operational fluency in GMP manufacturing, quality, and regulatory submissions
• Strong execution discipline and attention to detail
• Clear, concise, and professional communication under pressure
• Collaborative leadership without direct authority
• Exemplary organizational skills
• Experience in timeline management and risk management
• Aptitude for working independently under evolving conditions and with a sense of urgency to meet milestones
• Ability to respond quickly and effectively to evolving priorities
• Proficiency in active problem-solving and driving issues to resolution
• Proven ability to achieve results in a virtual setting

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

The Research Associate, Analytical Development supports analytical method development, implementation, and pre-qualification activities for Rion’s exosome technology. This role partners closely with Quality Control (QC) to support method transfers, routine testing support as needed, and continuous improvement. The successful candidate is hands-on at the bench, organized in documentation, and comfortable communicating results in a fast-paced, collaborative environment.

Key techniques include: mammalian cell culture, ELISA, RT-qPCR, HPLC, and colorimetric/fluorometric assays.

Responsibilities

• Execute analytical development studies (method development, implementation, and pre-qualification) to support Rion’s exosome technology.
• Perform wet-lab experiments and routine troubleshooting; conduct root-cause assessment of assay issues and communicate risks, deviations, and results in a timely manner.
• Support QC as needed, including sample testing support, documentation support, and continuous improvement activities.
• Support assay transfers to QC, including preparation of transfer packages, side-by-side testing, and documentation; may train QC staff on established methods.
• Maintain critical reagents (e.g., cell lines) and ensure readiness of materials required for analytical development.
• Document work using a paper-based laboratory notebook or an electronic laboratory notebook; maintain an organized index of experiments and results.
• Draft, revise, and help implement test methods/SOPs and work instructions; incorporate feedback from supervisors and cross-functional partners.
• Generate summary reports and/or presentations to communicate findings to Research & Development and QC teams.
• Maintain compliance for study execution (training, SOPs, and work instructions) and learn/adhere to applicable GLP guidance.
• Support day-to-day laboratory operations, including inventory management, procurement, and general laboratory/equipment maintenance.
• Collaborate with analytical development scientists to plan, design, and execute studies in a team setting.
• Support pre-qualification of analytical assays in alignment with ICH Q2(R2) guidelines.

Required Qualifications

• Bachelor’s or Master’s degree in Biological Sciences or a related field.
• 1–3 years of relevant industry experience in analytical development, Quality Control, or a biological sciences laboratory.
• Hands-on experience with mammalian cell culture.
• Ability to record data accurately and legibly; strong attention to detail.
• Strong organizational and time-management skills; ability to work effectively with shifting priorities.
• Proficiency with data analysis/graphing tools (e.g., Microsoft Excel, GraphPad Prism).
• Excellent written and verbal communication skills, including ability to summarize and present findings.
• Ability to work effectively in a collaborative team environment.

Preferred Qualifications

• Experience in a cGMP environment.
• Good understanding of compliance and cGMP considerations; familiarity with basic regulatory requirements (e.g., ICH, compendia).
• Experience authoring/revising test methods, protocols, and technical reports.
• Prior experience in an analytical development environment.

Work Authorization: Must be authorized to work in the United States. Visa sponsorship is not available for this position.

How to Apply: Please submit a resume (and optional cover letter). Include a brief summary of relevant analytical methods experience and availability to start.

Rion recognizes the importance of balance and flexibility in our work environment. We offer competitive benefits, services, and programs that provide employees with resources to pursue their career goals—both at work and in their personal lives.

We provide a competitive compensation package and a culture focused on development and wellbeing. Benefits may include:

• 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 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, and Parental Leave programs
• 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, occupational pneumoconiosis, or any other characteristic protected under applicable federal, state, or local law.

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.

Clinical Operations Manager

Location: Remote

Department: Clinical Operations  

Reports to: Vice President, Global Clinical Development and Operations

Company Overview:

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 musculoskeletal disorders. Our ultimate mission is to deliver cutting edge solutions accessible to any patient in need, anywhere in the world.

We are searching for an experienced and driven Clinical Operations Manager with a background in biotech/pharmaceuticals/CRO. This position is a full-time salary remote role.

Position Summary:

Reporting to the Vice President, Global Clinical Development & Operations. This role will oversee clinical trial(s) in patients in a variety of therapeutic areas; musculoskeletal, dermatology, wounds, medical aesthetics, cardiac, and pulmonary. You will manage day-to-day activities for multiple clinical studies, including creating and managing study timelines, drafting and reviewing study management plans, and performing CRO and vendor oversight.

This is an exciting opportunity for an individual with a Life Sciences or MD background, a proven track record of clinical protocol development, managing multiple studies, internal cross-functional collaboration and coordination, CRO and vendor management to join a dynamic team working to deliver high quality studies on time and within budget. The role is key to ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data are acceptable and suitable for global regulatory submissions. This individual ensures that assigned studies are executed according to ICH/GCP guidelines, applicable regulatory requirements, quality and standard operating procedures.

Job Responsibilities:

• Managing study progress from start-up to close-out activities and end of study reporting.
• Assuring adherence to intended timelines to achieve study goals while ensuring compliance with international GCP guidelines/regulations and SOPs/SWPs, identifying risks and implementing risk mitigation plans.
• Manage all aspects of assigned clinical studies, including the study team and all external vendors.
• Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
• Oversight and management of CRO and clinical vendors as appropriate to ensure successful conduct of the clinical trial and to ensure data integrity and quality.
• Oversight and management of multiple clinical trials from early development through licensure.
• Lead completion of study deliverables through active participation in all aspects of study design, execution, analysis and reporting, vendor selection and management, and oversight of investigator selection and management.
• Proactively managing study deliverables and milestones, including identifying and resolving trial related issues (quality, timelines, budget, resources).
• Medical Writing – clinical related deliverables (e.g., Investigator Brochure, clinical protocol development, informed consent & amendments, Annual Reports/DSUR, eCTD clinical modules, response to FDA questions, etc.)
• Ensure audit readiness at all times by assessing and mitigating study compliance with all regulatory requirements (knowledge of GCP, ICH guidelines, trial master file and regulatory requirements for clinical trial management is required)
• Participate in preparation of regulatory filings as needed
• Participate in process improvement initiatives including, but not limited to, contributing to generation of Standard Operating Procedures (SOPs), and collaboration with Clinical Quality, Regulatory and Laboratory staff on study compliance initiatives.
• Provide input in the development of clinical trial related documents including but not limited to: protocols, case report forms, informed consents, timelines, project oversight plan, monitoring plans, laboratory manuals, pharmacy manuals, training materials, and site initiation visit slide presentation.
• Effective communication with KOLs and Investigator site staff to support study delivery.
• Contributing to individual and team development through training initiatives and team building activities.

Qualifications

• BS degree or higher, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) or an MD degree from the US or abroad
• Minimum 10-15 years of experience in the pharmaceutical industry in a senior manager position performing clinical development and operations functions.
• Proven track record including internal cross-functional coordination, CRO and vendor management to deliver high quality studies to time and budget.
• Previous pharmaceutical industry experience Managing early through late phase clinical studies.
• Demonstrated experience in the identification of emerging risks and the ability to collaboratively champion solutions within a multi-disciplinary team to help resolve challenges.
• Must possess excellent project planning and priority setting skills, as well as excellent organizational and interpersonal skills and flexibility to accommodate rapidly changing priorities and deadlines.
• Solid project and vendor management, analytical and problem-solving skills.
• Prior experience with forecasting, tracking and reconciliation of study budgets.
• Prior experience with authoring and coordinating the development of clinical protocols, Investigator brochures and study reports.
• Excellent written and verbal communication skills.

Location

• Remote
• Travel to clinical site locations within the United States (up to 25% travel)
• Travel onsite to Rochester, Minnesota typically once a month

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.