Biotech cGMP Manufacturing Specialist II

Abzena Inc.; Bristol Township (Bucks County); On-site; USD 60,000 - 90,000; Full time

Job summary

Abzena Inc. in the United States is seeking an Associate I/II to perform large-scale bioconjugation processes for cGMP manufacturing projects. The Associate will support manufacturing, development, and processing of drug substances, ensuring product compliance and timely delivery to customers.

You will communicate production status, identify issues, and collaborate with process development, Quality Control and Quality Assurance to uphold regulatory standards and drive continuous improvement.

Qualifications

• Bachelor’s degree in chemistry, biology or engineering.
• A minimum of 2 years’ experience in a GMP pharmaceutical environment preferred.
• Experience with cGMP manufacturing operations and GxP principles.
• Understanding and application of cGMP requirements.

Responsibilities

• Works in GMP environment and ensures regulatory compliance.
• Performs manufacturing activities including complex tasks per cGMP, cGDP, SOPs, and Batch Records.
• Batch documentation and record generation.
• Materials sampling, staging, dispensing, and return.
• Equipment setup, operation, and cleaning.
• Use of appropriate personal safety equipment and engineering controls.
• In-process inspection and sampling.
• Assist quality systems activities and investigations.
• Participate in continuous improvement activities.
• Interface with process development, Quality Control and Quality Assurance.

Skills

GMP experience

Bioconjugation

cGMP knowledge

Team communication

Education

Bachelor’s degree in chemistry, biology or engineering

Job description

Abzena Inc. in the United States is seeking an Associate I/II to perform large-scale bioconjugation processes for cGMP manufacturing projects. The Associate will support manufacturing, development, and processing of drug substances, ensuring product compliance and timely delivery to customers.

You will communicate production status, identify issues, and collaborate with process development, Quality Control and Quality Assurance to uphold regulatory standards and drive continuous improvement.