Downstream Manufacturing Specialist

Downstream Manufacturing Associate or Scientist

Downstream Processing Manufacturing Associate or Scientist to oversee the purification of 50L to 2000L volumes for engineering, clinical, and commercial batches in a cGMP environment. This role requires advanced technical expertise in downstream processes, including AKTA purification skids (or similar), tangential flow filtration (TFF), and comprehensive knowledge of batch records, protocols, investigations, and technical documentation.

Essential Duties & Responsibilities

• Conduct downstream purification processes at various scales (50L to 2000L) within a cGMP environment, including tasks such as column packing, troubleshooting, and data analysis.
• Lead the development and execution of downstream purification processes, providing technical guidance.
• Use software systems to gather, monitor, and assess operational data, making real-time adjustments to downstream processes, instruments, or equipment as needed.
• Ensure the timely and efficient completion of engineering and clinical batches.
• Define specifications for downstream equipment and enhance manufacturing techniques to improve process efficiency.
• Work collaboratively with cross-functional teams and external vendors to resolve technical issues and maintain downstream production equipment.
• Strictly adhere to and enforce GMP and environmental health and safety (EHS) policies within the manufacturing environment.
• Lead investigations and implement corrective actions for any downstream process deviations encountered during batch execution.
• Perform additional duties as required, ensuring compliance with company policies and quality standards.

Qualifications & Requirements

A Bachelor’s or Master’s degree in chemical, biological, or biochemical sciences, with 4–5 years of relevant experience in the biopharmaceutical industry.

Demonstrated expertise in downstream purification within a cGMP and aseptic manufacturing environment.

Practical experience with AKTA Process skids or equivalent systems, and familiarity with single-use manufacturing consumables (e.g., bags, tube sets, columns, and process manifolds).

Thorough knowledge of GMP documentation and the ability to execute engineering and clinical batches.

Strong troubleshooting and problem-solving skills specific to downstream processes and purification.