Downstream Manufacturing Associate
Listed on 2026-02-12
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Manufacturing / Production
Pharmaceutical Manufacturing, Validation Engineer
This is a onsite role based New Jersey (relocation assistance available)
This is a hands-on role focused on downstream purification of mammalian cell–based cultures and the production of recombinant proteins supporting a broad biosimilars portfolio. The Scientist will execute purification activities for engineering, clinical, and commercial batches ranging from 50L to 1000L within a cGMP environment.
The position requires strong technical expertise in downstream processing, including AKTA purification systems (or equivalent), TFF, and GMP documentation such as batch records, protocols, and investigations. The successful candidate will work effectively both independently and as part of a cross-functional manufacturing team, with a strong understanding of cGMP compliance and BLA requirements.
Key Responsibilities- Execute downstream purification processes at multiple scales in a cGMP setting, including column packing, troubleshooting, and data analysis
- Provide technical input for purification process execution and process development activities
- Monitor and analyze operating data; make real-time adjustments to equipment, processes, or materials as needed
- Ensure timely execution of engineering and clinical manufacturing batches
- Define and optimize equipment operating parameters and manufacturing techniques
- Partner with internal teams and external vendors to resolve technical and equipment-related issues
- Adhere to GMP, environmental health, and safety policies; lead by example on the manufacturing floor
- Support investigations and corrective actions related to deviations during batch execution
- Complete additional responsibilities as assigned and comply with all company policies and standards
- Bachelor’s or Master’s degree in Chemical, Biological, or Biochemical Sciences
- 4–5+ years of relevant experience in the biopharmaceutical industry
- Prior experience in GMP and aseptic manufacturing environments
- Hands-on experience with AKTA Process skids (or similar systems)
- Familiarity with single-use technologies (bags, tubing, columns, process manifolds)
- Experience executing engineering and clinical batches and generating GMP documentation
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