Manufacturing Manager, Bioprocessing

Donaldson • Durham, NC

1d • Onsite

About The Position

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. The company offers a growing portfolio of purification solutions for a wide range of biologics and other viral particles. 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.

Requirements

• Bachelors 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.

Nice To Haves

• 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.

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, 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 and 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager