Commercial Process Development Director or Sr. Director (Wuxi, China)
Lead the technology transfer of products that are new to manufacture in Wuxi site. Activities include project planning, technical evaluation of equipments, starting material, packaging material, process development and validation, improvement.
Lead batch scale up, process develop in Wuxi site.
Lead cleaning and process validation activities, including defining the validation strategy (batches/tests), reviewing validation protocols/reports/
Results and supporting batch execution as needed.
Act as a primary technical "point of contact" with clients in Wuxi site. Implement technicals from clients in routine production.
Lead process change, process improvement in routine production.
Support investigations and lead/support their root cause analysis.
Provides proactive support in training and coaching to production staff.
Participate in SHE, Business Compliance, cGMP and all other compliance-related matters, where applicable.
Any other tasks as and when assigned by superior.
At least BS degree in pharmaceutics or other directly- related science.
Must be proficient with the requirements of the s-FDA/US-FDA/ EMEA cGMP regulations, ICH guidelines as well as drug development process.
Strong technical/manufacturing background in pharmaceutical and packaging operations in general and solid dosage in particular, including quality systems and process technology ( technology transfer, process validation, cleaning validation, problem solving)