The Company

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 can 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

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:

For Senior Scientist:

· 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