To fuel the next phase of expansion we are hiring 4 DSP Scientists. 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.
Downstream Manufacturing Scientist - Biologics
Location: On-site, USA - New Jersey
Type: Full-time
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.
