Lead Manufacturing Tech

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Isolere Bio, Inc. located in Research Triangle Park, NC, is one of Donaldson's latest additions 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.

The Lead Manufacturing Technician performs and documents 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 Manager 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 upstream and downstream purification including but not limited to fermentation, buffer prep, homogenization, chromatography, ultrafiltration, sterile filtration and filling.

• In coordination with the Manager, schedules tasks for a given shift and plan resource allocation. This includes production, validation or other project activities. Also, responsible for proper information sharing at shift exchange and ensure all issues are communicated appropriately.

• 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:

• Associates Degree in technical field or biotechnology certification from accredited program

• 3 or more years of biomanufacturing experience

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

Preferred Qualifications:

• Experience with upstream and/or downstream manufacturing process in a clean room GMP facility

• Experience with fermentation, separations and purification processes, including chromatography, ultrafiltration, and centrifugation

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

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

Key words: bioprocessing, biomanufacturing, downstream, chromatography, ultrafiltration, GMP, engineer

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