Drug Product Development Executive Director

This position is responsible for managing and overseeing all Drug Product Development (DPD) activities in one of the Shanghai sites, WGQ or Fengxian. Full time position based in Shanghai, China.

Direct line manager: Vice President, Head of Drug Product Development

Key roles and responsibilities

Strategic Planning

• Work with the senior management team in Global Durg Product Operations and other related functions to form Drug Product Development strategies and tactics to boost WuXi Biologics’ DP business
• Overall management of DPD operations, including capability and capacity enhancement, cost planning and control, efficiency and productivity optimization, etc.

Platform Development

• Drive the initiation, establishment and growth of new DP technologies and capabilities within GDPO.
• Project Execution and Team Collaboration
• Work with cross-functional teams (such as project management and CMC leaders) to ensure project progress and alignment with clients.
• Provide guidance to project teams on technical, regulatory, or business challenges.

Team and Talent Development

• Provide guidance to DPD staff and project teams on biologics DP development, manufacturing process development, technology transfer/scale up, etc.
• Lead recruitment, development, and retention of DPD personnel, further enhance the tech competitiveness of DPD in the global biologics drug product field.

Qualifications

• PhD in pharmaceutical sciences, biochemistry, biophysics, analytical sciences, or other related area.
• 10+ years of work experience in the area of biologics formulation and process development, DP technology transfer and/or scale up. Deep understanding of scientific principles for biologics characterization, stability and manufacturing. Experience in international organizations is preferred.
• At least 5 years of people management experience.
• Hands-on experience with IND/BLA dossier preparation for biologics, and with response to agency’s questions.
• Hands-on experience on biopharmaceutical development project management, leading cross-functional project teams.Proven track record for leadership, organization and communication skills to motivate team members,
• establish/maintain working relationship with colleagues and clients.
• Highly motivated, critical thinking, strong problem solving and collaborative.
• Good team worker, experienced in cross-functional team collaboration, such as project CMC team.
• Willing to take responsibilities, make difficult decisions and handle pressure at work.
• Familiar with FDA/EMA/NMPA regulations on biologic products, experience in regulatory filings in different regions.