The Director / Sr. Director of manufacturing is responsible for the leadership and direction of all aspects of the manufacturing function to ensure Rion’s clinical development activities and manufacturing meet all the recognized regulations and guidelines. The Director / Sr. Director will establish the manufacturing organization and infrastructure to support the clinical trials with a transition to commercial manufacturing within three to five years on all applicable GxP activities.
- Establish the manufacturing team by hiring, training, and mentoring in the area of the aseptic operations
- Collaborates with Human Resources and other functions to develop a multi-year staffing and recruiting plan for the facilities
- Provides leadership, vision, and management to the product manufacturing teams.
- Leads all aspects of manufacturing operations at the facility to manufacture clinical and commercial products (Human and Veterinary Rx, and Cosmetic) according to approved protocols, regulations, and schedules.
- Develop and manages KPIs and site goals, supports critical program milestones, and drives continuous improvement initiatives that are essential to meeting corporate goals.
- Rapidly and accurately communicates issues to senior leadership. Resolves manufacturing and facilities issues to mitigate any supply and production disruptions.
- Works effectively across departments, such as Quality Assurance, Facilities, Engineering, Project Management, Business Development, Regulatory, Quality Control, IT, and Supply Chain.
- Partners with product development to implement new production processes. Processes may include, but are not limited to, formulation, filling, and lyophilization.
- Oversees and approves schedules, production plans, and material requirements.
- Ensures the effective use of material, equipment, and personnel in manufacturing of the GMP products.
- Prepares and administers expense and capital budgets for the facilities. Recommends capital expenditures and aids in the planning and execution of the capital projects.
- Oversees, supports, and participates in cGMP and / or partner audits of all production areas within the facility.
- Maintains site inspection readiness and represents the manufacturing facility during regulatory and partner audits.
- Writes, reviews, and/or approves SOPs, specifications, regulatory filing, or other controlled documents as needed.
- Champions a culture of safety and establishes an E&HS Program.
- Directs and provides expert knowledge in the strategic function of Manufacturing
- Develops organizational strategy to support corporate goals, direction, and growth.
- Leads with impact & influence.
- Identifies, recruits, and retains talent.
- Manage performance and encourages employee engagement and results through delegation, continuous feedback and goal setting
- Maintains transparent and concise communication by sharing organizational information through department meetings, one-on-one meetings, and other venues.
- Bachelor’s degree in the physical or biological sciences, or chemical engineering required. Master’s degree preferred.
- Minimum of 10 years of experience in GMP production environment.
- Minimum of 5 years of leadership/supervisory experience.
- Experience with multiproduct biologics facility start-up
- Highly experienced in overseeing manufacturing operations in an aseptic and biologics manufacturing environment.
- Knowledge of transferring aseptic parenteral manufacturing.
- Working knowledge of industry practices, global regulations and experience interacting with multiple health authorities (e.g. FDA, EMA, etc.).
- Mindset and proven ability to drive inspection readiness at all times.
- Working knowledge of financial operations in a manufacturing environment.
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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