Night Cell Culture Manufacturing Associate I/II (GMP)

KBI Biopharma, Inc.; North Carolina; Presencial; USD 42.000 - 54.000; Jornada completa

Descripción de la vacante

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II (Nights) to perform downstream production activities for cell culture programs in a GMP environment.

The role covers media preparation, bioreactor operations, chromatography, ultrafiltration, and filling, with emphasis on documentation and compliance with GDP/GLP standards. The candidate should have basic knowledge of cell culture or purification, strong communication, and the ability to work in a fast-paced, 12-hour night schedule,

Formación

• Minimum: Bachelor's in a related science/engineering with GMP manufacturing experience, or HS diploma with relevant GMP experience.
• Basic knowledge of cell culture, fermentation, or purification operations preferred.
• Experience with single-use platform technology preferred.
• Excellent written and verbal communication skills required.
• Must be organized and able to work in a fast-paced, multitasking environment.
• Fluency in English (reading and writing).

Responsabilidades

• Manufacture cell culture products according to batch records while ensuring quality standards.
• Perform cleanroom operations with aseptic processing controls.
• Document manufacturing procedures in GDP-compliant records at the time of execution.
• Ensure proper issuance and accountability of items used in manufacturing records.
• Apply cGMP knowledge in daily tasks.
• Maintain 5S standards in the manufacturing environment.
• Operate and maintain equipment per SOPs.

Conocimientos

Communication skills

Fluent English

Reading & interpreting documents

Writing routine reports

Public speaking

Problem solving

Organized & multitasking

Educación

Bachelor's degree in related scientific/engineering discipline

High school diploma with GMP experience

Herramientas

Single-use platform technology

GMP manufacturing equipment

Descripción del empleo

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II (Nights) to perform downstream production activities for cell culture programs in a GMP environment.

The role covers media preparation, bioreactor operations, chromatography, ultrafiltration, and filling, with emphasis on documentation and compliance with GDP/GLP standards. The candidate should have basic knowledge of cell culture or purification, strong communication, and the ability to work in a fast-paced, 12-hour night schedule,