Downstream Manufacturing Associate We are recruiting a Downstream Manufacturing Associate for a hands-on role in the purification of mammalian cell-based cultures and production of recombinant proteins for biosimilars. This position involves handling purification volumes from 50L to 1000L for engineering, clinical, and commercial batches in a cGMP environment. Proficiency in operating AKTA purification skids, tangential flow filtration (TFF), and familiarity with batch records and technical documents is essential.
Essential Duties & Responsibilities: Execute downstream processes at various scales in a cGMP environment, including column packing, process troubleshooting, and data analysis. Operate and maintain downstream equipment, including AKTA skids and TFF systems. Perform in-process testing and data collection to ensure product quality and process consistency. Assist in preparing and reviewing quality management documents, including deviation reports, change control, and investigation reports. Collaborate with cross-functional teams to ensure the successful execution of engineering and clinical batches. Support process optimization efforts and implement improvements to enhance efficiency and product yield. Ensure compliance with GMP and safety regulations, including maintaining a clean and safe work environment. Assist in troubleshooting process-related issues and performing corrective actions as needed. Participate in investigations and corrective actions for deviations or process failures. Perform other duties as assigned and comply with all company policies and standards. Requirements: Education: Bachelor's degree in chemical, biological, or biochemical sciences. 3-5 years of related experience in downstream processing within the biopharmaceutical industry. Experience: Experience working in a GMP-compliant environment. Hands-on experience with AKTA purification systems and TFF. Familiarity with batch manufacturing and purification processes for recombinant proteins. Special Skills: Strong attention to detail and ability to follow protocols accurately. Effective communication and documentation skills. Ability to work collaboratively within a team and adapt to a fast-paced environment. Proficiency in basic computer applications, including Word and Excel. Work Environment & Physical Demands: Ability to work flexible hours, including weekends or evenings, as required. Capability to work under pressure and meet production deadlines. Some lifting and manual handling of equipment may be required.
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