AD, Process Engineering

Job Summary：
This role leads the design, optimization, and validation of pharmaceutical and API batch/semi-batch/continuous processes via QbD, DOE, and catalysis/transfer principles, while managing cross-functional teams and domestic-overseas projects to deliver on-time, high-quality process scale-up and commercialization solutions. It requires an advanced chemical engineering degree, 8–10 years of relevant experience (6–8 in pharma process engineering), bilingual English-Chinese proficiency, and hands-on skills in process modeling (Aspen Plus, DynoChem) and statistical analysis software.

Responsibilities：
1. Process Engineering​

• Lead the design and optimization of batch, semi-batch, and continuous reaction processes, including reaction engineering, kinetic studies, and reactor design, with a strong focus on multi-phase reaction systems.​
• Oversee downstream process unit operations, such as fractional distillation, membrane processes, batch & continuous extraction, crystallization design and scale-up, and dynamic drying (including modeling and simulation).​
• Apply knowledge of industrial catalysis, mass, and heat transfer to ensure efficient and stable process performance.​

2. QbD & Process Validation​

• Utilize DOE (Design of Experiments) for process design, optimization, validation, and PPQ (Process Performance Qualification) to ensure process robustness.​
• Conduct statistical data simulation and analysis, implement risk assessment protocols, and analyze non-DOE data using linear and non-linear regression methods.​
• Support process validation activities and contribute to PPQ execution, leveraging expertise in combining DOE and kinetic data analysis where applicable.​

3. Team & Project Management​

• Lead engineering teams in pharmaceutical and API development, managing early and late-stage process engineering projects.​
• Handle multiple concurrent projects with domestic and overseas clients, ensuring on-time and high-quality delivery.​
• Develop engineering proposals to meet client needs for process development, scale-up, and commercialization.​
• Collaborate effectively with cross-functional teams (R&D, manufacturing) and domestic/overseas clients to drive project success.​
• Operate and manage typical process engineering lab equipment, including PAT (Process Analytical Technology) tools and software.​

4. Software Application​

• Use process design, modeling, and simulation software (e.g., Aspen Plus, MATLAB, DynoChem preferred) for batch, semi-batch, and continuous processes.​
• Apply statistical analysis software (e.g., JMP, Modde) to analyze experimental data and support process optimization and validation.

Qualifications：
1. Ph.D. or Master’s degree (Ph.D. preferred) in Chemical Engineering or Engineering Science from a reputable
university
2. 8-10 years of overall working experience, including 6-8 years in pharmaceutical industry-related process engineering, with a focus on API drug substance process development and scale-up.
3. Proficiency in both English and Chinese is essential.
4. Has expertise in process engineering, QbD, process validation, team and project management, as well as proficiency in relevant software tools.