Process Research Group Leader or Project Leader

Major Responsibilities：

• Is the group leader of the process research group, and is a member of CMC management team. Or is the project leader for PRS section.
• Lead and supervise process R&D for NCEs both internally and externally for preclinical and early clinical studies.
• Supervise non-GMP and GMP manufacturing of API and intermediates at internal kilolab or at CMOs based on project needs.  Work with quality manager to ensure quality compliance of manufacturing activities.
• Represent PRS function at cross functional project team.  Provide critical feedbacks to project teams from PRS point of view. Coordinate PRS activities both locally and globally with different stakeholders.
• Manage collaborations with CRO/CMO for outsourcing activities for pRED China projects and global projects. Provide interim and final deliverables within project timeline and budget requirements.
• Serve as the lead person for regulatory related activities for drug substances, including CTA document preparation.
• Serve as the key contact person for pRED China to PRS.  Is responsible to align pRED China practices to global standards.  Is the key coordinator for pRED China and PRS in all PRS activities.
• Lead a group of 5-6 people with anticipated steady head count increase based on portfolio needs.  Is responsible for subordinates’ performance management and career developments.
• As a key member of CMC management team, contributes to department development and people development. 
• Is responsible for maintaining a close relationship and interactions with academic and industry leaders in PRS areas.  Is responsible for publications and generating patents.  Will represent pRED China PRS to give presentations at internal and external meetings.     
• Is responsible for drafting good quality reports on time.  Is expected to review, edit, and offer critical feedbacks to the reports generated by subordinates. 
• Is responsible for establishing a safety culture in PRS group.  Is responsible for SOP drafting and trainings. 

Requirement：

• Ph.D. degree in organic synthesis with at least 8 years (post graduate) of increasing responsibility and roles in small molecule (SM) process research and synthesis, ideally within both large pharma and biotech.  Strong hands-on experience in the area of process research and synthesis of SM NCEs. Rich R&D experience in preclinical and early clinical development. Experience in setting up and managing process research lab and kilolab. Extensive experience in project management in coordinating PRS activities with internal global stakeholders and external CMOs to ensure timely PRS supports for all projects.  High level knowledge and understandings in regulatory guidelines such as ICH, FDA, EMEA, and SFDA.  Experience in pilot plant operation is highly desirable.