Senior Biopharma Upstream Manufacturing Associate II

KBI Biopharma, Inc.; Durham (NC); On-site; USD 42,000 - 56,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II to perform upstream processing for biopharmaceutical products on a 2-2-3 day shift (6am–6pm).

Responsibilities include following GMP/GLP procedures, authoring SOPs/MBRs, CAPAs, and qualifying new equipment, with a focus on RFT and strict documentation. Candidates should have a related scientific or engineering degree or equivalent experience, and be prepared to work cross-functionally with QA, MS&T, facilities, and other departments

Qualifications

• Bachelor's degree or equivalent with related GMP manufacturing experience.
• Ability to follow approved procedures and maintain quality records.
• Strong written and verbal communication skills in English.

Responsibilities

• Manufacture bulk intermediates and drug substances per batch records.
• Operate in cleanroom with aseptic technique and gowning procedures.
• Document tasks in manufacturing records and logbooks per GDP.
• Maintain and service equipment per SOPs and safety rules.
• Ensure materials are issued and tracked during execution of a record.
• Demonstrate understanding of cGMP and apply to tasks.
• Support workplace organization and 5S principles.

Skills

Upstream processing

GMP

GLP

SOPs

CAPA

Education

Bachelor's degree in related science/engineering

High school diploma with related experience

Tools

Bioprocess equipment

Job description

KBI Biopharma, Inc. is seeking a Manufacturing Associate I/II to perform upstream processing for biopharmaceutical products on a 2-2-3 day shift (6am–6pm).

Responsibilities include following GMP/GLP procedures, authoring SOPs/MBRs, CAPAs, and qualifying new equipment, with a focus on RFT and strict documentation. Candidates should have a related scientific or engineering degree or equivalent experience, and be prepared to work cross-functionally with QA, MS&T, facilities, and other departments