Job Description:

The Early CMC and analytical group of Biologics in Beijing is seeking a highly motivated and experienced principal investigator in the Downstream Process Development team. The successful candidate will contribute for BeiGene’s downstream process platform optimization for the challenging biologics such as bispecific antibody, ADC. 

Responsibilities (including but not limited to)：

1). Lead the development of a streamlined and robust downstream process to support early-stage biologics development.

2). Work with early CMC development team transferring projects to pilot scale manufacturing to support the IND and clinical development.

3). Provide development strategies to enhance downstream platform capacities.

4). Lead downstream platform optimization through introducing new technology or improving workflow.

5). Responsible for downstream process scale up, pilot run, tech transfer.

6). Working closely with colleagues in GMP manufacturing to ensure coordination of project activities across all programs.

7). Key contributor to relevant CMC sections in IND/CTA submission.

8). Stay current with emerging trends in and introduce new technology to enhance workflow and capabilities.

Qualification Required:

Professional requirement:

1). PhD in biochemical, chemical engineering or relevant field with more than 3 years, or master’s degree with more than 5 years of relevant industry experience.

2). Hands-on experience in downstream process development for several biological molecule classes, especially for bispecific antibody and ADC; hands-on experience in downstream process scale up and pilot run.

3). In-depth understanding to design experiments and solve troubles.

4). Demonstrated experience in design of experiment with statistic software and data analysis, as well as high throughput development platform setup.

5). Proficient technical skills in chromatography、multiple clarification/filtration processes and other relevant downstream technology, skilled operation of AKTA Avant or high throughput system.

6). Experience with writing and reviewing development reports, SOPs and batch record.

7). Highly self-motivation to solve problems.

8). Excellent oral and written communication skills.