Biopharma Production Technician I

Bora Biologics USA LLC; Rockville (MD); Sur place; USD 60 000 - 62 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Performance-based incentives

Health coverage (medical, dental, and?

Résumé du poste

Bora Biologics USA LLC is seeking a Manufacturing Associate I to support the production of biopharmaceutical drug product for multiple clinical programs in a GMP setting. You will assist in planning, weighing materials, preparing solutions, and documenting manufacturing activities to ensure regulatory compliance.

The role emphasizes collaboration with QA, inventory maintenance, and involvement in projects to improve service quality and production efficiency within a compliant manufacturing

Qualifications

• High School diploma with exposure to science and math coursework, with 2+ years in FDA-regulated manufacturing.
• Associate’s degree with 1 year related experience in FDA-regulated environment.
• Bachelor’s degree in a related discipline with no experience acceptable.
• Knowledge of GMP processes and ability to write/revise technical documents.

Responsabilités

• Support manufacturing of material for clinical trials in GMP environment.
• Prepare and test solutions, coordinate sample collection/submission.
• Create and revise SOPs and GMP documents.
• Review logs and maintain clean, compliant records.
• Maintain inventory and assist with equipment maintenance.

Connaissances

Basic chemistry

Technical writing

Mathematical calculations

Detailed documentation

Team collaboration

Manufacturing timelines

Data analysis

Problem solving

Equipment operation

Physical ability

Overtime availability

Formation

High School diploma with science/math exposure

Associate’s degree in related field

Bachelor’s degree in related discipline

Description du poste

Bora Biologics USA LLC is seeking a Manufacturing Associate I to support the production of biopharmaceutical drug product for multiple clinical programs in a GMP setting. You will assist in planning, weighing materials, preparing solutions, and documenting manufacturing activities to ensure regulatory compliance.

The role emphasizes collaboration with QA, inventory maintenance, and involvement in projects to improve service quality and production efficiency within a compliant manufacturing