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.

Primary Responsibilities:

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.

Skills & 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).
• 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.

The GMP Manufacturing Associate's responsibilities will be:

• 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 [email protected]

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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