Downstream Manufacturing Scientist

The appointed DSP 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.