GMP Biotech Manufacturing Associate II – Gene Therapy

Proclinical Staffing; Bristol Township (Bucks County); On-site; USD 60,000 - 78,000; Full time

Job summary

Proclinical Staffing is seeking a Manufacturing Associate II in Bristol, PA to support cGMP bioconjugation and gene therapy manufacturing. The role involves performing large-scale manufacturing activities in a GMP environment, documenting batches, sampling materials, and assisting with quality systems.

The ideal candidate has a chemistry/biology/engineering background and hands-on experience with chromatography systems, UF-DF, and TFF skids.

Qualifications

• Bachelor's degree in chemistry, biology, or engineering.
• Experience in a GMP pharmaceutical environment.
• Knowledge of cGMP manufacturing operations and GxP principles.
• Familiarity with UF-DF and preparative chromatography systems.

Responsibilities

• Operate in a GMP-compliant environment adhering to regulatory standards.
• Perform manufacturing activities including batch documentation, material sampling, staging, dispensing, and returns.
• Set up, operate, and clean equipment and rooms per procedures.
• Conduct in-process inspections and sampling.
• Support quality systems and CAPA activities.
• Assist with maintenance, troubleshooting, and repair of equipment.
• Write and review SOPs and other cGMP documentation.
• Maintain accurate equipment logs and batch records.

Education

Bachelor's degree (Chemistry/Biology/Engineering)

Tools

AKTA Pilot

AKTA Ready

UF-DF

TFF skids

Job description

Proclinical Staffing is seeking a Manufacturing Associate II in Bristol, PA to support cGMP bioconjugation and gene therapy manufacturing. The role involves performing large-scale manufacturing activities in a GMP environment, documenting batches, sampling materials, and assisting with quality systems.

The ideal candidate has a chemistry/biology/engineering background and hands-on experience with chromatography systems, UF-DF, and TFF skids.