Manufacturing Manager, Bioprocessing

Donaldson Company • $100K — $120K *

Durham, NC 27713In-Person

Pharmaceuticals & Biotech

5 - 7 years of experience

1 month ago

Job Overview by Ladders

Qualifications

Bachelor's degree in science, engineering, manufacturing operations, or related field
5+ years of bioprocessing experience in biopharmaceutical or industrial biotechnology environments
Experience with upstream and/or downstream bioprocessing operations
Preferred: 1+ years of leadership or supervisory experience
Preferred: Familiarity with GMP-regulated manufacturing environments

Responsibilities

Oversee upstream fermentation and downstream purification operations
Coordinate production across various functions to meet objectives
Train and supervise manufacturing personnel
Draft and approve key documentation for production processes
Identify improvements for operational efficiency and quality
Support technology transfer and scale-up efforts for commercial manufacturing
Ensure maintenance and calibration of manufacturing equipment

Benefits

Working onsite at the Durham, NC facility
Opportunity to lead and manage a high-visibility role
Engagement with cutting-edge IsoTag™ bioprocessing technology
Focus on safety, quality, and continuous improvement
Collaborative work environment across varied manufacturing functions

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Full Job Description

Position Summary:

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.

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.

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About Donaldson Company

Donaldson Company, Inc. is a filtration systems manufacturer. The company's products include air and liquid filters for industrial, hydraulic, and aerospace applications. Donaldson's customers include manufacturers in the aerospace, defense, and industrial sectors. The company was founded in 1915 and is headquartered in Minneapolis, Minnesota.

Learn more about Donaldson Company

Size

13,100 employees

Market Cap

$7.2 billion

Industry

Manufacturing & Automotive

Net Income

$245.6 million

Founded

1915

5 Year Trend

+6.9%

Revenue

$2.5 billion

NASDAQ

DCI

* Ladders Estimates

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