Senior Biopharma Manufacturing Lead — Night Shift

KBI Biopharma, Inc.; Durham (NC); Hybrid; USD 65,000 - 90,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate I/II (Nights) to perform upstream or downstream bioprocessing of bulk intermediates and drug substances in a cGMP facility.

You will follow approved procedures, write CAPAs, and support qualification of new equipment, working with QA and MS&T teams. The role requires experience in upstream or downstream operations, strong documentation, and clear communication, with a rotating 2‑2‑3 night schedule and a focus on right‑first‑time

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline with 4-6 years’ GMP manufacturing operations experience.
• High school diploma with 7-10 years’ GMP manufacturing operations experience.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records and quality standards.
• Operate in a cleanroom environment and follow aseptic processing controls.
• Document tasks in manufacturing records and logs per GDP guidelines.
• Perform maintenance on production equipment according to SOPs.
• Ensure materials are issued and accounted for during record execution.
• Demonstrate understanding of cGMP and related tasks.
• Provide guidance to Manufacturing Associates and assist supervisor with workload distribution.

Skills

GMP compliance

SOP development

CAPA writing

Communication skills

English proficiency

Education

Bachelor's degree in related scientific or engineering discipline

High school diploma with GMP experience

Tools

ERP

MS Office

EDMS

Job description

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate I/II (Nights) to perform upstream or downstream bioprocessing of bulk intermediates and drug substances in a cGMP facility.

You will follow approved procedures, write CAPAs, and support qualification of new equipment, working with QA and MS&T teams. The role requires experience in upstream or downstream operations, strong documentation, and clear communication, with a rotating 2‑2‑3 night schedule and a focus on right‑first‑time