Quality Control Manager/Sr Manager - Aesthetics

Details

Job Type: Full-time, Monday-Friday onsite

Reporting Structure: Reports to the Senior Director Quality Control

Qualifications

Bachelor’s Science / Master of Science (MS) (Preferred)

Quality Control Experience: Minimum 8-10 years

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 aesthetics and 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 with a background in biotech/pharmaceuticals and/or cosmetic products. This position is an on-site and full-time salary role.

Position Overview

Rion is recruiting a highly motivated Manager of Quality Control to help advance its manufacturing of commercial cosmetic products. The ideal candidate will contribute to our goals of growing our manufacturing capabilities and expanding our aesthetic product portfolio.

The Manager will be responsible for leading the Rion Quality Control Laboratory and oversight of Contract Testing QC labs in support of aesthetic product manufacturing, establishment of internal QC processes, and maintenance of the control strategy for cosmetic products.

Key Responsibilities

The primary responsibilities of this role are to:

• Plans and executes multiple assays in Rion’s own QC and with contract testing labs
• Experience in traditional QC testing including but not limited to viscosity, residual moisture, FTIR, and pH
• 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 degree in Biology, Biochemistry, Chemistry, or a relevant scientific discipline
• 8-10+ years of relevant cosmetic, biotech, and/or pharma industry experience, including Quality Control experience supporting cGMP areas
• 3+ years’ experience supervising/managing direct reports
• 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

Benefits Overview

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.

Job Type: Full-time

Pay: $110,000.00 - $160,000.00 per year

Benefits:

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

Application Question(s):

• Will you now or in the future require sponsorship for employment visa status?

Ability to Relocate:

• Rochester, MN 55901: Relocate before starting work (Required)

Work Location: In person