Senior Manufacturing Associate II, Night Shift (Biopharma)

KBI Biopharma, Inc.; North Carolina; Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate II - Nights to support downstream processing of bulk intermediates and drug substances on a 7PM-7AM rotating shift.

The role requires adherence to GMP/GLP, writing SOPs/MBRs, CAPAs, and ensuring batch records are accurate, with responsibility for downstream unit operations and related manufacturing support activities across cross-functional teams.

Formación

• Bachelor’s degree in a scientific or engineering discipline with 5+ years’ GMP manufacturing operations experience or a high school diploma with 10+ years’ GMP experience.
• Excellent written and verbal communication skills are required.
• Ability to read and interpret documents such as safety rules and batch production records.

Responsabilidades

• Manufacture bulk intermediates and drug substances per batch records in compliance with quality standards.
• Operate in a cleanroom environment with aseptic processing controls.
• Document tasks in manufacturing records and logbooks; follow GDP guidelines.
• Maintain and troubleshoot equipment per SOPs; support CAPA activities.
• Guide and support Manufacturing Associates and assist the supervisor with workload planning.

Conocimientos

GMP manufacturing operations

Communication skills

Documentation interpretation

Educación

Bachelor’s degree in a scientific or engineering discipline

High school diploma with 10+ years GMP experience

Herramientas

MS Office

ERP

EDMS

Production software

Bioprocessing equipment

Descripción del empleo

KBI Biopharma, Inc. is seeking a Senior Manufacturing Associate II - Nights to support downstream processing of bulk intermediates and drug substances on a 7PM-7AM rotating shift.

The role requires adherence to GMP/GLP, writing SOPs/MBRs, CAPAs, and ensuring batch records are accurate, with responsibility for downstream unit operations and related manufacturing support activities across cross-functional teams.