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Isolere Bio, Inc. located in Research Triangle Park, NC, is one of Donaldson's latest addition to a growing list of biotechnology initiatives. Isolere Bio develops reagents that combine engineered biopolymers with tunable phase separation, with affinity ligands that confer the unique material properties to the biologic target of interest. The company offers a growing portfolio of purification solutions for a wide range of biologics, including AAV, lentivirus, mRNA, plasmid DNA and other viral particles. This portfolio of IsoTag reagents are first of their kind and will catalyze a paradigm shift in bioprocessing. They offer significant competitive advantages - improving productivity and quality while reducing the overall cost of goods for increasingly complex biologic drugs. www.isolerebio.com

The Facility/Operations Manager will play a crucial role in driving the growth and success of Isolere as we build out our manufacturing capabilities to support commercial growth. The successful candidate will be responsible for the overall Operational execution for the Isolere Facility in Research Triangle Park, North Carolina. They will provide leadership and support to a team focused on the development and manufacturing of novel affinity purification products, drive day to day site operations, and ensure the Safety, Quality, Delivery and Cost of our products and processes.

Due to the early nature of Isolere's products, a great candidate will have an entrepreneurial mindset while still being able to navigate the established, supporting corporate culture of Donaldson and contribute to its growing life sciences vertical.

Role Responsibilities:

Execution:

• Lead the operational function for the site including equipment, supply chain, purchasing, planning, environmental health and safety (EHS), project management, logistics, and project management.

• In partnership with the manufacturing manager, they will be responsible for the site operations functions in the plant for all shifts to ensure on-time production and shipment of high-quality product and facilitating site R&D activities.

• Ensure that all factory equipment and processes operate in a safe manner and in accordance with our Environment Health & Safety framework.

• Continually monitor results achieved in relation to planned goals and undertake necessary corrective action to achieve the desired results in Safety, Quality, Delivery & Cost.

• In partnership with manufacturing and R&D leadership, oversees functions including purchasing, inventory management, planning the production flow, troubleshooting manufacturing issues, supporting staff, and effectively managing daily capacity to meet schedule requirements.

• Prepare and maintain site budgets, capital budgets, forecasts, and resource requirements. Maintain and control site inventories at optimum levels to meet anticipated Customer demands without excess investment.

• Manage the plant Project List, set priorities, and ensure projects meet cost & schedule targets.

• Drive a Continuous Improvement Culture in Lean methodologies & waste elimination. Use DPS framework to ensure the site is engaged at all levels.

• Other tasks and assignments as required to meet business objectives.

Strategic:

• Coordinate operations resources necessary to support development activities within the Isolere business.

• In partnership with R&D and manufacturing leadership, develop new and improved manufacturing processes needed to manufacture new products and are necessary to maintain a competitive advantage in the marketplace.

• Develop and recommend plans concerning capital equipment, facilities, operations, and staffing investments Isolere facility in RTP, NC.

• Develop and maintain a favorable employee environment and work with team members on their personal growth and development goals to ensure employees feel encouraged and motivated to contribute to their full potential.

• Develop and foster a strong culture of safety by ensuring all employees operate with a safety-first mindset.

• Create an open and continuous improvement approach to safety. Provide prompt and effective action to eliminate unsafe acts or conditions as they become apparent.

Supervisory:

• Functional Operations team: supply chain, purchasing, planning, environmental health, and safety (EHS), project management, logistics, and project management. Note that some of these functions will be dotted line.

Minimum Qualifications:

• Bachelor's degree in science or engineering, or another related field.

• 5+ years of leadership experience in a highly regulated, preferably cGMP (FDA) manufacturing environment, including managerial or supervisory experience or a combination of education and experiences.

• 1+ experience managing large scale facilities, capital projects, and/or CDMOs

• Financial and Logistics analytical skills to include budget tracking, inventory and supply chain management

• Experience with ERP such as Oracle or similar

Preferred Qualifications:

• Experience in bioprocessing, pharmaceutical manufacturing, or FDA regulated reagent manufacturing

• Leadership in Lean methodologies

• Master's Degree

Key words: Operations, Facility, Management, cGMP, ERP, FDA

Employment opportunities for positions in the United States may require use of information which is subject to the export control regulations of the United States. Hiring decisions for such positions are required by law to be made in compliance with these regulations. Applicants for employment opportunities in other countries must be able to meet the comparable export control requirements of that country and of the United States.

Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.