Night Shift Senior Manufacturing Associate - Downstream

KBI Biopharma, Inc.; Durham (NC); On-site; USD 70,000 - 95,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC, is seeking a Senior Manufacturing Associate II for night shift (7 PM–7 AM) to perform downstream processing of bulk intermediates and drug substances under GMP.

You will follow approved procedures, document actions, and support equipment qualification and CAPA activities. Responsibilities include executing downstream operations (chromatography, tangential flow filtration, virus inactivation, bulk filling), maintaining batch records, training staff, and

Qualifications

• Bachelor’s degree in a scientific discipline with 5+ years’ GMP manufacturing experience
• Experience in upstream/downstream operations preferred
• Excellent written and verbal communication skills

Responsibilities

• Perform downstream operations per batch records and GDP requirements
• Document tasks in logbooks and manufacturing records with accuracy
• Assist in SOP/MBR development and CAPA writing
• Operate and maintain downstream equipment per SOP and preventive maintenance
• Coordinate with QA, MS&T, facilities, and supply chain for schedule adherence
• Support 5S and workplace organization initiatives

Skills

Downstream processing

GMP

SOP/MBR writing

CAPA writing

Cross-functional collaboration

ERP familiarity

Education

Bachelor’s degree in a related scientific or engineering discipline

Tools

Single-use platforms

ERP systems

Documentation software

Job description

KBI Biopharma, Inc. in Durham, NC, is seeking a Senior Manufacturing Associate II for night shift (7 PM–7 AM) to perform downstream processing of bulk intermediates and drug substances under GMP.

You will follow approved procedures, document actions, and support equipment qualification and CAPA activities. Responsibilities include executing downstream operations (chromatography, tangential flow filtration, virus inactivation, bulk filling), maintaining batch records, training staff, and