Independently develop, validate, and oversee the performance of testing methods 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.

Requirements:

• A bachelor’s degree in chemistry, biology or a related field, and a minimum of five years of GMP manufacturing and/or GMP laboratory industry experience are required.
• An equivalent combination of a graduate degree and experience sufficient to successfully perform the job duties as listed above is acceptable.

The Director of Facilities and Engineering is a senior leadership role responsible for overseeing all aspects of facilities management, engineering operations, and capital projects within Rion’s labs and manufacturing environment. This position ensures the reliable and compliant operation of manufacturing, laboratory, and administrative facilities, supporting the organization’s mission to deliver high-quality products. The ideal candidate brings a strong engineering education, extensive industry experience, and proven leadership in regulated environments. 

Key Responsibilities 

• Lead and manage the facilities and engineering activities, fostering a culture of safety, compliance, innovation, and continuous improvement. 

• Develop and implement strategic plans for facility operations, preventive maintenance, utilities, and capital projects to support business objectives and regulatory requirements. 

• Oversee the design, construction, commissioning, and validation of new facilities and utilities, ensuring alignment with cGMP, EMA, OSHA, and other relevant regulations. 

• Manage facility budgets, vendor relationships, and service contracts to optimize operational efficiency and cost-effectiveness. 

• Collaborate with cross-functional teams (Quality, EHS, Manufacturing, R&D, Supply Chain) to ensure facility readiness and operational excellence. 

• Lead risk assessments, emergency preparedness, and business continuity planning for all facilities and critical systems. 

• Stay current with industry trends, emerging technologies, and best practices in pharmaceutical engineering and facility management. 

Qualifications 

• Bachelor’s degree in engineering (Mechanical, Electrical, Chemical, or related field) required. 

• Minimum of 15 years of progressive experience in facilities and engineering roles within the pharmaceutical, biotechnology, or life sciences sector. 

• Demonstrated expertise in managing complex, regulated facilities (GMP, GLP, etc.), including laboratory and manufacturing environments. 

• Proven leadership ability with experience building and managing high-performing teams. 

• Strong knowledge of regulatory requirements, quality systems, validation, and EHS standards. 

• Excellent project management, analytical, and problem-solving skills. 

• Outstanding communication, negotiation, and stakeholder management abilities. 

Preferred Skills and Attributes 

• Professional certifications (e.g., PE, PMP, LEED AP, IFMA) are a plus. 

• Experience with digital facility management systems, automation, and smart building technologies. 

• Track record of implementing sustainability and energy conservation initiatives. 

Additional Information 

• This position is based at our primary pharmaceutical manufacturing and R&D locations in Rochester, MN. Occasional travel (10%) may be required to audit or inspect equipment manufacturers or testing.  

The Analytical Development Research Associate will contribute to analytical method development, implementation, and pre-qualification of methods focused on Rion’s exosome technology. This role will work closely with Rion Quality Control to execute method transfers and support continuous improvement. As such, the candidate will possess the technical skills required to conduct experiments and assays in a wet lab environment involving techniques such as mammalian cell culture, ELISA, RT-qPCR, HPLC and colorimetric/fluorometric-based assays. The Analytical Development Research Associate will be responsible for the execution of experiments, as well as data interpretation and final reporting. The position affords the opportunity to serve as a key member of Rion’s scientific team and contribute to the advancement of exosome therapeutics. The Analytical Development Research Associate will work closely with the Analytical Development Scientists and support the efforts of Quality Control/Process Development. As such, the successful candidate will work in an upbeat, highly collaborative and dynamic environment. Additional responsibilities associated with this position will involve assisting in day-to-day laboratory operations such as inventory management, procurement, and general laboratory and equipment maintenance.

Requirements:

Position Overview 

The Sr. Scientist of Quality Control should be able to independently develop, validate, and oversee the performance of testing methods 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. 

Key Responsibilities 

• Perform analytical testing (e.g. protein expression, bioassays, flow cytometry and particle analysis, cell-based assays) of GMP and non-GMP product samples. 

• Maintain required documentation according to departmental policy to support product release and process development. 

• Write SOPs, analytical procedures 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. ICH guidelines, FDA-issued guidance) 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. 

• Develop additional analytical test methods as required, often as a member of a cross functional team. 

• Perform and oversee biologic drug product characterization testing in support of research, process development and manufacturing efforts 

Qualifications 

• Ph.D in life sciences discipline with 2-5 years industry experience 

• M.S. with >5 years industry experience 

• B.S. with >10 years industry experience 

• Experience working in a GMP or regulated laboratory environment 

Additional Information 

• Schedule: Monday – Friday  

• Work Location: Rochester, MN 

• Relocation Assistance: Yes 

• Job Type: Full-time, Salaried