Senior Nightshift Downstream Bioprocess Specialist

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 (Nights) to perform upstream or downstream processing of bulk intermediates and drug substances for biopharmaceutical products in a 12-hour night shift 7PM–7AM on a 2-2-3 rotation.

The role requires following GMP/GLP procedures, maintaining good documentation, and contributing to SOPs/MBRs, CAPAs, and equipment qualification, while collaborating with QA, MS&T, facilities, and other teams to ensure compliant, reliable

Qualifications

• Bachelor's degree in a related scientific or engineering discipline with 4-6 years' experience in related GMP manufacturing operations.
• Or high school diploma with 7-10 years' experience in related GMP manufacturing operations.
• Basic knowledge of upstream (cell culture or fermentation) or downstream (purification and bulk filling) unit operations is preferred.

Responsibilities

• Manufacture bulk intermediates and drug substances per manufacturing batch records in compliance with quality standards.
• Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures.
• Document each task involving manufacturing records and logbooks following GDP at the time of execution.
• Provide direction/guidance to Manufacturing Associates.
• Help supervisor to distribute the workload and ensure others understand the requirements of their tasks.

Skills

Excellent communication skills

Ability to read/interpret documents

Education

Bachelor's degree in science or engineering

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 (Nights) to perform upstream or downstream processing of bulk intermediates and drug substances for biopharmaceutical products in a 12-hour night shift 7PM–7AM on a 2-2-3 rotation.

The role requires following GMP/GLP procedures, maintaining good documentation, and contributing to SOPs/MBRs, CAPAs, and equipment qualification, while collaborating with QA, MS&T, facilities, and other teams to ensure compliant, reliable