GMP Manufacturing Associate, Downstream

GMP Manufacturing Associate - Permanent - Bristol, PA

Drive cGMP excellence by powering large‑scale downstream manufacturing that brings life‑changing therapies to reality.

Proclinical is seeking a GMP Manufacturing Associate, Downstream, to join a team in the US. This position requires strong collaboration, attention to detail, and adherence to regulatory standards.

The successful candidate will perform large-scale bioconjugation processes for cGMP manufacturing projects. You will be responsible for ensuring compliance with Good Manufacturing Practices (GMP) and contributing to the successful production of drug substances.

• 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).
• Proficiency in optimizing bioprocesses.
• Hands‑on experience with preparative chromatography systems (e.g., AKTA Pilot, AKTA Ready, AKTA Explorer) and manual or automated TFF skids.
• Strong understanding of cGMP manufacturing operations and GxP principles.
• Knowledge of cGMP requirements and their application.

• Operate in a GMP environment while ensuring regulatory compliance.
• Perform manufacturing activities, including complex tasks following cGMP, cGDP, SOPs, and Batch Records.
• Handle batch documentation, including record generation and review.
• Conduct material sampling, staging, dispensing, and return processes.
• Set up, operate, and clean equipment and rooms as per procedures.
• Utilize personal safety equipment and engineering controls effectively.
• Perform in‑process inspections and sampling.
• Support investigational and quality systems activities.
• Assist with preventative maintenance, troubleshooting, and equipment repair.
• 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 for manufacturing.
• Ensure proper execution of Master Batch Records, SOPs, and validation protocols.
• Maintain accurate equipment logs and batch records.
• Ensure cleanliness and proper assembly of manufacturing equipment and areas.
• Train on and adhere to all policies, procedures, and regulatory requirements.
• Communicate effectively with clients, supervisors, and colleagues.
• Uphold ethical and quality standards in all operations.
• Perform additional duties as assigned.

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at

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