Upstream Bioprocessing Associate I — Day Shift

KBI Biopharma; North Carolina; On-site; USD 45,000 - 70,000; Full time

Job summary

KBI Biopharma in North Carolina is seeking a Manufacturing Associate I/II to perform upstream bioprocessing in a GMP/GLP environment on a 2-2-3 day shift (7am–7pm). The role involves following approved procedures, maintaining documentation, and supporting equipment qualification.

Responsibilities include batch record documentation, aseptic processing in cleanrooms, cross-functional collaboration with QA, MS&T, facilities, and engineering, and contributing to continuous improvement with

Qualifications

• Bachelor’s degree or equivalent in a scientific/engineering field plus related cGMP manufacturing experience.
• Experience in upstream bioprocessing and familiarity with cleanroom operations.
• Strong documentation and GMP/GLP compliance, with attention to detail.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records and standards.
• Perform aseptic operations in a cleanroom, including gowning and cleaning.
• Document tasks in manufacturing records and logbooks with GDP practice.
• Operate and maintain equipment per SOPs and assist in qualification activities.
• Ensure materials are issued/ accounted for during a record execution.
• Apply knowledge of cGMP and related regulatory expectations.
• Participate in workplace organization and 5S initiatives.

Skills

English language proficiency

Communication skills

Reading & writing

Teamwork

Education

Bachelor’s degree in a related scientific or engineering discipline

High school diploma and relevant experience

Tools

MS Office

ERP

EDMS

Production equipment software

Job description

KBI Biopharma in North Carolina is seeking a Manufacturing Associate I/II to perform upstream bioprocessing in a GMP/GLP environment on a 2-2-3 day shift (7am–7pm). The role involves following approved procedures, maintaining documentation, and supporting equipment qualification.

Responsibilities include batch record documentation, aseptic processing in cleanrooms, cross-functional collaboration with QA, MS&T, facilities, and engineering, and contributing to continuous improvement with