DP MSAT-Technology Transfer Specialist, Assistant Engineer

Job Responsibilities

1) Perform laboratory work as required, including but not limited to the execution of DP process studies, data analysis, and report preparation. Develop equipment methods and prepare corresponding protocols and reports. Support project-related studies and ensure experimental records and data are organized in compliance with company requirements.

2) Support cross-functional evaluations for introducing new molecule modalities into GMP DP facilities, ensuring GMP regulatory compliance and alignment with site-specific compliance requirements.

3) Conduct comprehensive feasibility analysis for manufacturing various drug products in shared facilities, including assessment of cross-contamination risks

4) Coordinate with the 3rd party toxicologist to work on PDE/OEL assessment of biologics.

5) Lead or participate in DP tech transfer, process validation or other project related activities.

6) Draft MSAT-related documentation (e.g., gap analysis and risk assessment, TTP, PFD), analyze production/development data and reports to ensure data authenticity and integrity, and support domestic and foreign regulatory applications.

7) Conduct the DP process-related investigation and provide technical support for sterile drug product manufacturing

8) Engage in the client/ authority audit support as needed.

9） DP material management, including but not limited to supporting the technical evaluation of DP process materials, and the establishment and maintenance of material-related databases.

Qualification Education

Bachelor's degree or above in Pharmaceutical Engineering, Bio/chemical/process Engineering, Biotechnology, Toxicology, Biostatistics, Life science or related field. Graduates from 211/985 Project universities are preferred.

Experience

1. More than 1 year of relevant experience in MSAT, process development or production; prior experience with New Product Introduction in a GMP facility is preferred.

2. Be familiar in GMP and other related regulations/guidance.

Skills

Good verbal and written communication skills in both English and Chinese is preferred.