Manufacturing Manager, Bioprocessing

About the Role

We are seeking a Manufacturing Manager, Bioprocessing for Isolere Bio, a division of Donaldson and home to the proprietary IsoTag™ technology—a bioprocessing purification solution that delivers better-than-affinity performance without the chromatography column. This high-visibility role will lead and manage establishing production of IsoTag reagents as well as supporting efforts to scale production. Qualified candidates must be able to work an on-site schedule at our Durham, NC office/facility.

Responsibilities

• Oversee upstream fermentation processes and downstream purification operations including chromatography, tangential flow filtration (TFF), and buffer preparation.
• Coordinate production activities across manufacturing, quality, operations, and process development functions to meet business objectives.
• Train, develop, and supervise manufacturing personnel.
• Draft, review, and approve batch records, deviations, investigations, change controls, and corrective actions.
• Identify and implement improvements to increase operational efficiency, product quality, and manufacturing capacity.
• Support technology transfer and process scale-up activities from development to commercial manufacturing by participating in SOP and batch record generation, documentation, training requirements, and other needs for tech transfer.
• Ensure proper operation, maintenance, calibration, and qualification of manufacturing equipment.
• Support commissioning and qualification of new manufacturing equipment and process technologies, as well as leading efforts for expansion of capabilities and equipment.
• Foster a culture of accountability, safety, quality, and continuous improvement.

Qualifications

• Bachelor’s degree in science, engineering, manufacturing operations, or related field.
• 5+ years of Bioprocessing experience in biopharmaceutical, industrial biotechnology, or related manufacturing environments.
• Experience with upstream and/or downstream bioprocessing operations or related bioprocessing manufacturing operations.

Preferred Qualifications

• 1+ years of leadership or supervisory experience within a manufacturing setting.
• Experience with fermentation, chromatography, and/or tangential flow filtration (TFF).
• Strong understanding of process control, batch manufacturing, and production scheduling.
• Strong organizational, communication, and leadership skills.
• Experience in GMP-regulated manufacturing environments.
• Experience with scale-up, technology transfer, and process validation activities.
• Knowledge of Lean Manufacturing, Six Sigma, or Operational Excellence methodologies.
• Experience with contract manufacturing or customer-facing production programs.

This position is not eligible for relocation assistance. Applicants must be currently and legally authorized to work in the United States without the need for current or future sponsorship.