Job Content：

Lead a group of scientists to develop the technology platform for combination products (drug-device combination), e.g. pre-filled syringe, autoinjector and on-body delivery system.
Manage technical teams and provide guidance in study design, execution and troubleshooting, to support projects on combination products.
Help establish a quality management system suitable for combination products, ensuring compliance with regulatory requirement for both pharmaceutical products and medical devices, e.g. 21 CFR Part 4, 210/211, 820; EU MDR; ISO 13485, 14971, IEC 62366-1, ISO 11608, ISO 10993, etc.
Lead design control and risk management activities to support combination product development, manufacture, regulatory submission, query responses and inspection.
Manage combination product-specific analytical test method development, qualification/validation, design verification and validation. Work with quality team on supplier quality evaluation, DHF audit, change controls, complaint analysis and CAPA investigation.
Assist department head and work with other leaders in the department/business units, to align strategies/practices within the department and between departments.
Motivate team members to learn fast, strive to achieve more.
Recruit and train scientists, engineers and associates; develop team members to work independently on combination product development and/or manufacturing.
Work with cross-functional teams (such as project management and CMC) to ensure project progress and alignment with clients.


Requirements：

MS or PhD in pharmaceutical sciences, biochemistry, analytical sciences, material sciences, or other related area.
15+ years (MS) or 10+ years (PhD) work experience in combination product or medical device development/manufacturing. Experience in international organizations is preferred.
At least 5 years of people management experience (10 or more people).
Solid understanding of the science and technology related to material science and medical device, etc.
Hands-on experience in at least one of the following areas: medical device, formulation development, or delivery device development.
Excellent leadership, organizational and communication skills to establish/maintain working relationship with colleagues and clients.
Highly motivated, critical thinking, strong problem solving and collaborative leader.
Good team worker, experience in cross-functional team collaboration, such as project CMC team.
Willing to take responsibilities, make decisions and handle pressure at work.
Familiar with FDA/EMA/NMPA regulations on medicinal products, experience in regulatory filings in different regions (IND/ IMPD/BLA/MA).
Proficient in English, excellent communication in writing and oral.
Experience in client management is a plus.