Senior Associate: Bulk Drug Substance Manufacturing

BioSpace; Holly Springs (NC); Sur place; USD 75 000 - 105 000; Plein temps

Résumé du poste

Amgen North Carolina is seeking a Senior Associate for Bulk Drug Substance Manufacturing Services to support the ANC2 facility expansion and startup. You will assist weigh and dispense of materials, media, buffers, and solution preparation, and help with equipment setup and process documentation in a cGMP environment.

You will collaborate across QA/QC, Facilities & Engineering, PPIC, Mfg., and Regulatory teams to enable readiness and continuous improvement.

Qualifications

• High School Diploma/GED + 4 years manufacturing or regulated environment experience.
• Associates Degree + 2 years manufacturing or regulated environment experience.
• Bachelor's Degree + 6 months manufacturing or regulated environment experience.
• Master's Degree (any related field).

Responsabilités

• Set up, clean, sanitize and monitor equipment and area.
• Run critical process tasks and document results in EBRs.
• Assist in startup, qualification and readiness activities.
• Support training and qualification of staff.
• Maintain compliance with cGMP and safety requirements.

Connaissances

Manufacturing experience

cGMP knowledge

Safety compliance

SOP adherence

Team collaboration

Formation

High School Diploma or GED

Associates degree

Bachelor's degree

Master's degree

Outils

MS Office

EBR/MES

DeltaV

Description du poste

Amgen North Carolina is seeking a Senior Associate for Bulk Drug Substance Manufacturing Services to support the ANC2 facility expansion and startup. You will assist weigh and dispense of materials, media, buffers, and solution preparation, and help with equipment setup and process documentation in a cGMP environment.

You will collaborate across QA/QC, Facilities & Engineering, PPIC, Mfg., and Regulatory teams to enable readiness and continuous improvement.