Biotech Manufacturing Associate II - GMP Cell Culture

KBI Biopharma, Inc.; Durham (NC); Presencial; USD 45 000 - 65 000; Tempo integral

Resumo da oferta

KBI Biopharma, Inc. in Durham, NC seeks a Manufacturing Associate II to perform upstream or downstream production activities for cell culture programs in a GMP environment.

You will follow SOPs, batch records, and GDP/GMP/GLP standards, maintaining documentation and process ownership in a fast-paced facility. The role requires basic knowledge of cell culture or related operations, strong communication, organization, and the ability to work 12-hour shifts in a cleanroom setting with a focus on

Qualificações

• Minimum degree and GMP experience per the job posting.
• Basic knowledge of cell culture, fermentation or purification is preferred.
• Excellent written and verbal communication skills required.

Responsabilidades

• Manufacture cell culture products per batch records and quality standards.
• Perform cleanroom operations with aseptic controls and gowning.
• Document procedures in GDP-compliant records during execution.
• Ensure proper issuance and accountability of items used in records.
• Demonstrate knowledge of cGMP in daily tasks.
• Maintain 5S standards in the manufacturing area.
• Operate and maintain equipment per SOPs.

Conhecimentos

Cell culture basics

Fermentation

Purification operations

Communication skills

Organizational skills

Multitasking

Formação académica

Bachelor's degree in science/engineering

High school diploma with GMP experience

Descrição da oferta de emprego

KBI Biopharma, Inc. in Durham, NC seeks a Manufacturing Associate II to perform upstream or downstream production activities for cell culture programs in a GMP environment.

You will follow SOPs, batch records, and GDP/GMP/GLP standards, maintaining documentation and process ownership in a fast-paced facility. The role requires basic knowledge of cell culture or related operations, strong communication, organization, and the ability to work 12-hour shifts in a cleanroom setting with a focus on