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Careers

Manager, Quality Control

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.

The Position
Reporting to the Vice President, Quality Operations, the Manager, Quality Control is a hands-on manager that can organize and lead a team of Quality Control (QC) personnel, support and execute QC testing, and contribute significantly to the overall QC strategy. The ideal candidate will have experience working in a GMP QC laboratory setting, experience with cell and gene therapy test methodologies, compendial safety testing and enjoy a fast-paced, collaborative, and vibrant startup culture. 

We are searching for an experienced and driven individual with a background in biotechnology/pharmaceuticals. A team player with a sense of urgency will thrive in this role.

Job Responsibilities:

Plans and performs multiple bioanalytical assays

  • Manages QC quality records including, but not limited to, Out-of-Specification Investigations, Deviations, CAPAs, and Change Controls, and ensures that all related activities are completed in a timely manner
  • Establishes routine operations to govern QC activities, including scheduling sample testing, performing documentation reviews, ordering supplies, and oversight of QC equipment maintenance and calibration
  • Serves as the QC Subject Matter Expert (SME)
  • Authors, reviews, and approves QC-related documentation (CoA, Methods, SOPs, reports, etc.) and provides documentation support to QA, as needed
  • Collaborates with the Research and Product Development team in the transfer of analytical assays to QC
  • Coordinates with Manufacturing for in-process and product release test sample submission and testing
  • Directs testing for and supports the product stability program
  • Attends functional and cross-functional meetings to discuss ongoing work and align priorities

Qualifications:

  • BS or MS degree in Biology, Biochemistry, Chemistry, or a relevant scientific discipline is required, at a minimum
  • 8-10+ years of relevant biotech/pharma industry experience, including Quality Control experience supporting cGMP areas
  • 3+ years’ experience supervising/managing direct reports
  • Manages coaches and develops the growing team of QC Scientists
  • Demonstrated industry knowledge of cGMP
  • Experience leading people and/or projects with history of achieving results and outstanding outcomes
  • Strong communications skills: a team player who can lead, mentor, and inspire others
  • Experience participating and/or supporting regulatory inspections preferred
  • Gene or cell therapy product experience preferred
  • A proven ability to work successfully within a 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

Additional Information:

  • Schedule: Monday – Friday
  • Work Location: Rochester, MN (on-site)
  • Work Remotely: No
  • Job Type: Full-time, Exempt
  • Direct Reports: 2+
  • Reports To: Vice President, Quality Operations

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.

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