The Sr. Manager / Associate Director is responsible for the development of the processes to support GMP manufacturing and scaleup or scale out of the Purified Exosome Product (PEP) in collaboration with R&D and manufacturing teams. The Sr. Manager / Associate Director will establish a core process development team comprised of scientists to support multiple indications and future product platforms.
- Design and perform lab-based experiments and activities to develop drug product formulations and manufacturing processes for Rion’s exosome-based products.
- Conduct drug product process optimization and process characterization activities.
- Work with CROs and CMOs to tech transfer and scale-up drug product manufacturing and fill-finish activities.
- Collaborate with other line functions within the project CMC team to deliver project milestones on time and within budget.
- Author relevant drug product sections in regulatory filings and address agency questions.
- Support Manufacturing Management and Quality in deviation investigations and product life cycle management.
- Executes process development strategy and timeline to ensure phase-appropriate manufacturing processes and methods
- Use risk management, investigational techniques, root cause analysis and quality concepts in the identification and evaluation of compliance risks
- Review essential elements of scale-up and technology transfer leading to a successful process validation and a robust commercialization
- Degree in a scientific discipline or equivalent in engineering.
- PhD with 5+years related experience OR BA/BS/MS with a minimum of 6-8 years related experience.
- Expert knowledge of scientific principles and concepts.
- Must have hands-on experience in formulation and process development for proteins and biologics, stress stability studies, fill-finish process optimization and clinical compatibility studies.
- Must have experience managing CMO relationships and clinical Drug Product fill-finish activities.
- Must have excellent laboratory experience and knowledge of analytical instrumentation used in formulation development of biologics.
- Must have excellent problem solving, verbal and written communication skills.
- Experience in DOE statistical approach in formulation and process development is desired.
- Working knowledge of quality and regulatory requirements of biologics products including ICH guidelines.
- Experience in both the early and late stage product development is desired.
- Experience working with the CMC teams preferred.
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.
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 very 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.
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