Manufacturing Manager, Bioprocessing

Donaldson is committed to solving the worlds 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.

Position Summary:

We are seeking a Manufacturing Manager Bioprocessing for Isolere Bio a division of Donaldson and home to the proprietary IsoTag technologya 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.

Role 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.

Minimum Qualifications:

• 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.

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.

Relocation: This position is not eligible for relocation assistance.

Immigration Sponsorship Not Available:

• Applicants for this position must be currently and legally authorized to work in the United States without the need for current or future sponsorship (e.g. H-1B J-1 F-1 CPT OPT etc.).

• Donaldson will not offer immigration sponsorship or assume sponsorship of an employment visa for this position.

• International relocation or remote work arrangements outside of the U.S. will not be considered.

Equal Opportunity Employer including Disability and Veterans

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.

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