- (Princeton)

PAT

Tech Transfer

IND / BLA

GLP

5S

DoEJMP / Minitab

ICH / USP / EPQbD

Responsibilities :

Responsible for upstream / downstream biopharmaceutical process development and optimization (including but not limited to cell culture and purification processes) for monoclonal antibodies, bispecific antibodies, fusion proteins, etc.

Explore and develop novel process platforms, including continuous processing, high-density cell culture, and Process Analytical Technology (PAT).

Participate in process technology transfer (Tech Transfer) and provide scale-up manufacturing support.

Prepare relevant technical documents to support IND / BLA filings.

Conduct experiments in compliance with GLP (Good Laboratory Practice) requirements, ensuring traceability and regulatory compliance in R&D processes.

Participate in laboratory 5S operations and maintenance.

Requirements :

Masters degree or higher in Bioengineering, Biotechnology, Chemical Engingeering, Pharmaceutical Engineering, or related fields.

Hands-on experience in mammalian cell culture or protein purification is preferred.

Familiarity with statistical tools such as DoE (Design of Experiments) and proficiency in process modeling and data analysis (JMP, Minitab, etc.).

Knowledge of global biopharmaceutical regulations (ICH, USP, EP) and industry guidelines (e.g., QbD principles).

Excellent literature search capabilities coupled with analytical thinking and problem-solving skills

Excellent teamwork and cross-functional communication abilities.