CMC Lead, Associate Director~Director

This position can be based in Shanghai, Wuxi or Suzhou

About WuXi Biologics

WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. The company’s history and achievements demonstrate its commitment to providing a truly one-stop service offering and strong value proposition to its global clients.

Our Vision

“Every drug can be made and every disease can be treated” by building an open-access platform with the most comprehensive capabilities and technologies in the global biologics industry

Our Mission

To accelerate and transform the discovery, development and manufacturing of biologics through a comprehensive open-access platform, enabling our global healthcare partners and benefiting patients worldwide

Job Responsibility

· As the CMC leader of assigned projects for the company, provide technical leadership to steer the CMC activities en route to successful IND filing and/or late stage development and BLA submission to regulatory agencies such as US FDA, EMA, NMPA, WHO, etc.

· Participate and show leadership in establishing WuXi Biologics CMC strategies and recommendations to support all ongoing projects in CMC development.

· Lead CMC projects with good understanding of potential technical challenges and meeting the regulatory requirements and ICH guidelines.

· Collaborate with CMC functional areas to ensure successful execution of various CMC strategies, on-time delivery of results and staying within budget.

· Chart the course, track progress against goals and outline key strategic events for project. Manage project scope definitions and changes, and budgets.

· Serve as the center of solution for technical issues. Address any challenges and issues that arise. Make hard decisions if needed.

· Engage effectively with key stakeholders to ensure transparency on program status and alignment on program plans, goals, resource requirements and timelines.

· Build a solid communication with client to ensure alignment between WuXi Biologics and clients.

· Provide leadership in development and manufacturing alliance management, product development and manufacturing strategy

· Support BD efforts and proposal writing team to enhance current service offering and develop new clients.

Opportunities

· Broaden and deepen understanding and experience in biologics development

· Gain cross-functional knowledge in real life biologics development and CMC management

· Develop leadership skill

· Enhance personal well-roundedness in preparation for executive capacity

Required Qualifications

· Advanced degree (PhD or MS) in Bio/Chemistry, Bio/Chemical Engineering, Life Sciences or related major with 10-15 years of applicable work experience. Exceptional candidates with 5-10 years of relevant working experience will also be considered.

· Proven track record of expertise in any areas of biologics CMC development (e.g., CLD, bioprocess, analytical, formulation, manufacturing science, etc.), good understanding of overall CMC strategy, risk and resource management, regulatory requirements and ICH guidelines.

· Demonstrated strategic decision-making abilities as well as problem-solving skills.

· Excellent verbal and written communication skills in both English and Chinese.

· Ability to work effectively across functions, teams and stakeholders.

· Excited at the vision and mission of WuXi Biologics, and embracing WuXi Biologics PROUD culture

Preferred Qualifications (Not Required)

· Experience in formulation and/or drug product development highly desirable.

· Previous working experience at or with CDMO a plus.

· Basic level in Korean, Japanese, Cantonese or other languages will be a plus.

· Experience in writing regulatory documents and submissions a plus