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Quality Control Manager/ Senior Manager

3 months ago

Rochester, United States Rion Full time

Quality Control Manager/ Senior Manager



Job Type: Full-time

Number of openings for this role:1


Full Job Description:

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 Quality Control Manager/Senior Manager with a

background in biotech/pharmaceuticals. This position is a full-time salary role.


Position Description:


Rion is recruiting a highly motivated Manager/Senior Manager of Quality Control to help

advance its mission to free patients from the siege of autoimmune disease. The ideal

candidate will contribute to our goals of navigating bringing extracellular vehicles to approved

therapeutic products.


The Manager/Senior Manager will be responsible for leading the Rion Quality Control

Laboratory and oversight of Contract Testing QC labs in support of clinical manufacturing,

establishment of internal QC processes, and maintenance of the control strategy for

investigational products and moving towards licensure.


Reporting to the Senior Director Quality Control, the candidate will:

Essential Duties & Responsibilities -

 Plans and is able to perform multiple bioanalytical assays

 Experience in western blot, flow cytometry, cell based assays, particle size analysis, etc.

 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

stablishes 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

Additional Skills & Qualifications: REQUIREMENTS:

 MS or Ph.D. 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



Schedule:

 Monday to Friday


Work Location:

 On-site Rochester, Minnesota 5 days / week


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.

 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 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.