DP MSAT-Tech Transfer and Innovation Specialist, Principal Engineer

Job Responsibilities

1) Lead DP MSAT innovation projects, including but not limited to the design and execution of innovation initiatives aligned with capability expansion and policy requirements; oversee project tracking, progress reviews, and outcome delivery, with outputs translated into publications, patents, and other intellectual property achievements.

2) Lead the development and implementation of strategies for new drug product container closure system SKUs, including the establishment of integrated technical assessment packages, quality and regulatory compliance packages, and supplier strategies; conduct comprehensive feasibility analysis for manufacturing various drug products in shared facilities, including assessment of cross-contamination risks

3) Lead or participate in DP tech transfer, process validation or other project related activities, ensuring successful execution and alignment with quality, regulatory, and business requirements.

4) Prepare DP-MSAT related technical documentation (e.g., gap analysis and risk assessments, TTP, PFD); review and analyze development and manufacturing data to ensure data integrity and support regulatory submissions and inspections.

5) Lead DP process investigations and provide technical expertise to support sterile drug product manufacturing; support project-related studies and ensure experimental records and data are maintained in compliance with company standards and GMP requirements.

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

Qualification Education

Ph.D. degree in Pharmaceutical Engineering, Bio/chemical/process Engineering, Biotechnology, Toxicology, Biostatistics, Life science or related field. Graduates from 211/985 Project universities and those with oversea study experience are preferred.

Experience

1. 0-3 years 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

1. Good verbal and written communication skills in both English and Chinese.

2. Good experience and knowledge on data processing and statistical analysis is preferred.