Bioprocess Manufacturing Lead — Scale-Up & Tech Transfer

Donaldson; Durham (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Donaldson seeks a Manufacturing Manager, Bioprocessing for Isolere Bio, based at our Durham, NC site. You will lead establishing production of IsoTag reagents and scale-up activities from development to commercial manufacturing, ensuring compliance and high-quality output.

You will oversee fermentation and purification operations, collaborate with quality, operations and process development teams, train staff, and drive process improvements in a GMP environment.

Qualifications

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

Responsibilities

• Oversee upstream fermentation and downstream purification operations.
• Coordinate production activities across manufacturing, quality, operations and process development.
• Train, develop and supervise manufacturing personnel.
• Review and approve batch records, deviations, investigations, change controls, and CAPAs.
• Identify improvements to increase efficiency, product quality, and capacity.
• Support tech transfer and process scale-up from development to commercial manufacturing.
• Ensure operation, maintenance, calibration, and qualification of equipment.
• Support commissioning and qualification of new equipment and expansion.
• Foster a culture of accountability, safety, quality, and continuous improvement.

Skills

Bioprocessing experience

Leadership/ Supervisory

Process scale-up

Education

Bachelor's degree in science/engineering

Job description

Donaldson seeks a Manufacturing Manager, Bioprocessing for Isolere Bio, based at our Durham, NC site. You will lead establishing production of IsoTag reagents and scale-up activities from development to commercial manufacturing, ensuring compliance and high-quality output.

You will oversee fermentation and purification operations, collaborate with quality, operations and process development teams, train staff, and drive process improvements in a GMP environment.