Night-Shift Bioprocess Specialist II

KBI Biopharma; Durham (NC); Sur place; USD 70 000 - 100 000; Plein temps

Résumé du poste

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate I/II to perform upstream or downstream bioprocessing for biopharmaceutical products.

The role requires adherence to GMP, GDP, and GLP, and may involve authoring SOPs/MBRs, CAPAs, and equipment qualification. 12-hour shifts (6PM-6AM) on a rotating 2-2-3 schedule in a cGMP facility with cross-functional collaboration across QA, MS&T, facilities, and IT.

Qualifications

• Bachelor's degree in a related scientific or engineering discipline with 4–6 years' GMP manufacturing experience or high school with 7–10 years' GMP manufacturing experience.
• Bachelor's degree with 5+ years' GMP manufacturing experience for Senior Manufacturing Associate II; high school with 10+ years' experience for Senior Manufacturing Associate II.

Responsabilités

• Manufacture bulk intermediates and drug substances per batch records and in compliance with quality standards.
• Perform aseptic operations in a cleanroom environment including gowning and cleaning procedures.
• Document tasks in manufacturing records and logbooks per GDP at execution.
• Maintain equipment per applicable SOP and ensure materials are issued and accounted for.
• Demonstrate understanding of cGMP and apply it to tasks and responsibilities.
• Support workplace organization and cross-functional collaboration with QA, MS&T, facilities, engineering, supply chain, IT, and other groups.

Formation

Bachelor's degree in a related scientific or engineering discipline

High school degree with related GMP manufacturing operations experience

Excellent written and verbal communication skills

Description du poste

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate I/II to perform upstream or downstream bioprocessing for biopharmaceutical products.

The role requires adherence to GMP, GDP, and GLP, and may involve authoring SOPs/MBRs, CAPAs, and equipment qualification. 12-hour shifts (6PM-6AM) on a rotating 2-2-3 schedule in a cGMP facility with cross-functional collaboration across QA, MS&T, facilities, and IT.