Manufacturing Associate II

Join a team transforming the future of medicine through cutting-edge bioconjugation and gene therapy manufacturing in Bristol, PA.

About the role

The successful candidate will perform large-scale bioconjugation processes for cGMP manufacturing projects, ensuring compliance with Good Manufacturing Practices (GMP), maintaining production quality, and meeting delivery timelines. This position involves collaboration across various teams and offers an opportunity to contribute to the development and processing of drug substances in the gene therapy space.

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 corrective and preventive actions (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.

Requirements

• Bachelor's degree in chemistry, biology, or engineering.
• Experience in a GMP pharmaceutical environment.
• Familiarity with normal flow filtrations and tangential flow filtrations (UF-DF).
• Hands-on experience with preparative chromatography systems (e.g., AKTA Pilot, AKTA Ready) and manual or automated TFF skids.
• Knowledge of cGMP manufacturing operations and GxP principles.
• Understanding of bioprocess optimization.