Description

Responsibilities

 Participate in the full process of technology transfer from R&D to production, review technology transfer reports, and draft validation protocols and reports.

 Engage in process troubleshooting, collect and statistically analyze critical process data, and provide solutions for process and cost optimization.

 Monitor GMP compliance implementation, responsible for updating process documents, validation management, deviation management, and responding to domestic and international inspections.

 Track technological advancements in pharmaceutical manufacturing (e.g., AI), responsible for exploring, evaluating, piloting, and promoting new pharmaceutical technologies.

 Follow regulatory updates from FDA/EMA/WHO/ICH/NMPA, responsible for interpreting, translating, training, and implementing new regulatory policies.

 Develop expertise in one or two specialized areas of pharmaceutical production to become an SME, thereby enhancing the factory’s technical capabilities.

 Actively participate in operational excellence projects to improve factory efficiency.

Qualifications

 Education:

Master degree or above in Organic Chemistry, Pharmacy, Pharmaceutics or related fields; PhD preferred.

 Experience:

Solid experimental skills in organic synthesis or pharmaceutics.

 Language:

Fluent in English (listening, speaking, reading, writing).

 Other Skills:

Proficient in using data analysis/statistical software.

 Additional Competencies:

1) Strong interest in pharmaceutical production with willingness for long-term career development in this field.

2) Clear logical thinking and a rigorous scientific mindset.

3) High initiative, strong learning ability.

 Work locations: Shanghai, Chengdu, Xiamen, Jinan, Lianyungang