Downstream Process Researcher (MJ013914)

A Downstream Process Researcher is sought to develop and optimize biological drug purification processes, including deep filtration, chromatographic separation, ultrafiltration/dialysis, and virus inactivation/removal. The role involves analyzing critical quality attributes and process parameters, solving technical issues, and participating in pilot-scale development, technology transfer to GMP production, and documentation for IND/BLA applications. Responsibilities also include evaluating new purification technologies and maintaining instruments.

Must Have

• Responsible for the development and optimization of downstream purification processes for biological drugs.
• Analyze Critical Quality Attributes (CQA) and Critical Process Parameters (CPP).
• Solve technical problems such as yield, purity, and host protein residue.
• Participate in pilot-scale purification process development (e.g., AKTA system operation).
• Complete process scale-up and technology transfer to GMP production.
• Establish process development technical documents (process specifications, SOPs, validation plans).
• Support the writing of IND/BLA application materials.
• Evaluate the applicability of new purification technologies (e.g., continuous flow chromatography, membrane chromatography).
• Responsible for daily instrument maintenance and other downstream process development related work.

I. Process Development and Optimization

1.1. Responsible for the development and optimization of downstream purification processes for biological drugs, including deep filtration, chromatographic separation (affinity/ion exchange/hydrophobic, etc.), ultrafiltration/dialysis, virus inactivation/removal, and other process steps;

1.2. Analyze Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) during the purification process, and solve technical problems such as yield, purity, and host protein residue;

II. Technology Transfer and Project Application

1.1. Participate in pilot-scale purification process development (e.g., AKTA system operation), complete process scale-up and technology transfer to GMP production;

1.2. Establish process development technical documents (process specifications, SOPs, validation plans), and support the writing of IND/BLA application materials;

III. Platform Construction and Management

1.1. Evaluate the applicability of new purification technologies (e.g., continuous flow chromatography, membrane chromatography);

1.2. Responsible for daily instrument maintenance and other work related to downstream process development.

Deadline: September 10, 2026

Number of recruits: 1 person