GMP Bioconjugation & Gene Therapy Associate II

Proclinical Group; Bristol (VA); On-site; USD 60,000 - 75,000; Full time

Job summary

Proclinical is seeking a Manufacturing Associate II to join a GMP-compliant biomanufacturing team in Bristol, PA. The role supports large-scale bioconjugation and gene therapy manufacturing, ensuring quality, compliance, and timely delivery.

You will work across QC, QA, and process development, handling batch documentation, equipment setup, in-process sampling, deviations, and CAPAs, with hands-on experience on AKTA systems and UF-DF filtration.

Qualifications

• Bachelor's degree in chemistry, biology, or engineering.
• Experience in a GMP pharmaceutical environment.
• Familiarity with UF-DF filtration.
• Hands-on experience with preparative chromatography systems (AKTA) and TFF skids.
• Knowledge of cGMP manufacturing operations and GxP principles.

Responsibilities

• Operate in a GMP-compliant environment, ensuring adherence to regulatory standards.
• Perform manufacturing activities, including batch documentation, material sampling, staging, dispensing, and returns.
• Set up, operate, and clean equipment and rooms as per procedures.
• Conduct in-process inspections and sampling.
• Support investigational and quality systems activities.
• Assist with preventative maintenance, troubleshooting, and repair of equipment.
• Participate in continuous improvement initiatives.
• Collaborate with process development, Quality Control, and Quality Assurance teams.
• Initiate deviations, assess product quality impacts, and propose CAPAs.
• Write and review SOPs and other cGMP documentation.
• Ensure proper execution of Master Batch Records, SOPs, and validation protocols.
• Maintain accurate equipment logs and batch records.
• Train on and adhere to all policies, procedures, and safety standards.
• Communicate effectively with clients, supervisors, and colleagues.
• Perform other duties as assigned.

Skills

GMP manufacturing

Bioprocess optimization

UF-DF filtration

AKTA Pilot / AKTA Ready

cGMP knowledge

Cross-functional collaboration

Education

Bachelor's degree in chemistry, biology, or engineering

Tools

AKTA Pilot

AKTA Ready

TFF skids

Job description

Proclinical is seeking a Manufacturing Associate II to join a GMP-compliant biomanufacturing team in Bristol, PA. The role supports large-scale bioconjugation and gene therapy manufacturing, ensuring quality, compliance, and timely delivery.

You will work across QC, QA, and process development, handling batch documentation, equipment setup, in-process sampling, deviations, and CAPAs, with hands-on experience on AKTA systems and UF-DF filtration.