Donaldson is committed to solving the world's most complex filtration challenges. Together, we make cool things. As an established technology and innovation leader, we are continuously evolving to meet the filtration needs of our changing world. Join a culture of collaboration and innovation that matters and a chance to learn, effect change, and make meaningful contributions at work and in communities.

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

Combining Isolere's deep expertise in liquid phase separation, and Donaldson's filtration technology expertise, and global sales and manufacturing footprint, we are on a fast-track to develop and commercialize Isolere's novel affinity liquid phase separation reagents for biologics purification.

As an Engineering Technician Lead, you will support our downstream manufacturing in a clean room setting. This person will perform and document daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, revising cGMP documents, ensuring compliance to cGMP, as well as maintaining equipment and facilities. This position works closely with leadership to coordinate critical activities collaboratively and utilizes resources efficiently.

Role Responsibilities:

• Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record and DOT compliance system. Coordinates and/or leads process steps as required, serving as a process step(s) expert.

• Manufacturing Steps for Downstream purification including: Buffer Prep, Homogenization, Chromatography, UF/DF, Sterile Filtration and Filling.

• In coordination with the Manager, schedule tasks for shifts and plan resource allocation. This includes production, validation or other project activities.

• Documents/records and reviews cGMP data and information (including documentation of deviations) for processing steps and/or equipment activities, following standard operating procedures. Develops and/or revises documents as needed. Key documentation includes batch records and equipment logbooks. Ensure completeness of documents real time review.

• Actively participates in training activities, managing their own individual training plan. Provides training to other associates as required and shares knowledge with others. Observes performance of employees, provides timely and targeted coaching for employees, and provides feedback to the Manager mid and end of year.

• Initiates / investigates deviations, develops and implements corrective and preventative actions as required by supervisor. Leads and/or actively participates in troubleshooting. Serves as possible SME.

Minimum Qualifications:

• Bachelor's Degree in a scientific or engineering discipline

• 2 years of direct biomanufacturing experience

• Knowledge of policies/standards (cGMP, ISO 9001/13485, 21CFR820)

Preferred Qualifications:

• 4 years' of direct biomanufacturing experience

• Experience with managing a Downstream manufacturing process in a clean room facility.

• Experience with a bulk downstream protein purification process, including but not limited to Harvest, Chromatography (HIC and AEX), Buffer prep, UF/DF, and Filling.

• Experience in Clean-in-Place and Sterilization-in-Place systems

• Highly detailed oriented with excellent documentation skills and exceptional troubleshooting abilities

Key words: biomanufacturing, ISO, downstream manufacturing, clean room, technician, cGMP, troubleshooting, innovation, bio*

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.