Global Life Science Hub is thrilled to partner with a biologics powerhouse on the brink of exponential growth! With 2 commercial products already on the market and a third approval expected any day, they're expanding and renovating their New Jersey facility to scale up production from 50L to 2000L.
To fuel the next phase of expansion, we are hiring 4 DSP Scientists. The appointed scientists will run and pack chromatography columns and execute TFF processes for purifying volumes ranging from 50L to 2000L in a cGMP environment. A strong background in downstream processing is crucial for efficiently executing engineering, clinical, and commercial batches.
Responsibilities: Execute downstream processes at multiple scales in a cGMP environment, including chromatography column packing, TFF operations, and data analysis.Provide technical leadership in the development and execution of purification processes.Utilize software tools to collect and analyze operating data, making real-time adjustments to optimize product yield and equipment performance.Ensure timely execution of engineering and clinical batches, maintaining high-quality standards.Establish and enhance equipment specifications, driving improvements in manufacturing techniques.Collaborate with cross-functional teams and external vendors to troubleshoot technical issues and maintain production equipment.Adhere to GMP guidelines and lead compliance with environmental health and safety policies.Coordinate investigations and implement corrective actions for issues encountered during batch execution.Perform additional duties as assigned to support team objectives and adhere to all company policies and standards.Experience/Qualifications: Bachelor's or Master's degree in chemical, biological, or biochemical sciences with 2+ years of relevant experience in the biopharmaceutical industry.Proven experience in GMP and aseptic manufacturing environments.Proficiency with AKTA process skids or similar systems, along with familiarity with single-use manufacturing consumables (e.g., bags, tube sets, columns, and process manifolds).Strong understanding of engineering and clinical batch execution, with a solid grasp of GMP documentation and compliance.
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