Nightshift Purification Senior Bioprocess Associate

KBI Biopharma, Inc.; Durham (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate I/II for the Nights shift (7pm-7am) in Durham, NC. The role covers upstream or downstream processing of bulk intermediates and drug substances following GMP and GDP standards.

The incumbent will draft SOPs/MBRs, CAPAs, and assist in equipment qualification while maintaining strict documentation and cross-functional collaboration. Ideal candidates hold a related Bachelor's degree with GMP manufacturing experience and strong

Qualifications

• Follow GMP/GLP procedures and write documentation.
• Knowledge of cGMP in manufacturing operations.
• Ability to interpret batch records and SOPs.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records.
• Operate in a cleanroom with aseptic processing controls.
• Document tasks in manufacturing records and logs.
• Provide guidance to Manufacturing Associates and assist supervision.

Skills

Cell culture

Purification

Bulk filling

Single-use platform

GMP knowledge

Communication skills

Education

Bachelor's degree in a scientific or engineering field

High school diploma with GMP experience

Tools

MS Office

ERP

EDMS

Production equipment software

Job description

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate I/II for the Nights shift (7pm-7am) in Durham, NC. The role covers upstream or downstream processing of bulk intermediates and drug substances following GMP and GDP standards.

The incumbent will draft SOPs/MBRs, CAPAs, and assist in equipment qualification while maintaining strict documentation and cross-functional collaboration. Ideal candidates hold a related Bachelor's degree with GMP manufacturing experience and strong