Senior Director, CMC Management

Responsibilities

• Provide project leadership supporting IND enabling and late-stage product development CMC activities.
• Participate and show leadership in establishing WuXi Biologics CMC strategies and recommendations in supporting all ongoing projects in CMC development.
• Lead CMC projects with a good understanding of potential technical challenges and meet the regulatory requirements and ICH’s quality and efficacy guidelines.
• Collaborate with CMC functional areas to ensure successful execution of various CMC projects and delivery of results on time and within budget.
• Chart the course, track progress against goals, and outline key strategic events for the project.
• Manage project scope definitions and changes, and budgets.
• Serve as the center of solution. Address any challenges and issues that arise. Make hard decisions.
• Engage efficiently with key stakeholders to ensure transparency on program status and alignment on program plans, goals, resource requirements, and timelines.
• Build a solid communication with clients to ensure alignment between WuXi Biologics and clients.
• Provide leadership in development and manufacturing alliance management, product development, and manufacturing strategy.
• Assist in recruiting, training, and retaining a high-performance CMC team to ensure the best quality service and leadership in CMC management functions worldwide.
• Support BD efforts and proposal writing team to enhance current service offerings and develop new clients.
• Develop and manage operational budgets and supervise teams to ensure IP and EHS compliance.

Qualifications

• Advanced degree (PhD or MS) in Bio/Chemistry, Bio/Chemical Engineering, Life Science, or related major with 8+ years of applicable work experience.
• Good knowledge of CMC strategy, risk and resource management, regulatory requirements, and ICH guidelines.
• Experience in two or more functional areas in Project Management, Cell Line Development, Cell Culture, Purification, Analytical, Formulation, Manufacturing, Manufacturing Support, QC or QA in the biologics industry.
• Experience in writing regulatory documents and submissions and the ability to work on multiple CMC projects at a time.
• Experience with staff management and/or CMC team management.
• Strategic view and leadership abilities as well as hands-on problem-solving skills. Experience in managing projects is required.
• Excitement about the vision and mission of WuXi Biologics.
• Ability to effectively work across all levels, functions, sites, and companies.
• Excellent verbal and written communication skills in both English and Chinese.

Opportunities

• Broaden personal knowledge and experience in the field of biologics.
• Integrate cross-functional knowledge in real-life drug development and commercialization process.
• Develop leadership skills to facilitate contributions from different functions.
• Develop well-around knowledge in preparation for executive opportunities.
• Independence/Accountability: Must be a self-starter, self-motivated, and highly flexible in this home-based position with about 10%-15% travel. Must be organized and detailed-oriented.
• Problem Solving: Proven experience in creating and carrying out successful plans and processes to solve complex problems.
• Leadership Activities: Work closely with team members across all CMC related business units and with the Wuxi Biological management team to ensure coordination of all efforts and real-time communication with all stakeholders.
• Communication Skills: Proficiency in English is required. Basic skills in Mandarin are strongly preferred. Excellent communication skills (verbal, written, and presentation skills).

What we offer

• An attractive salary, which is customary in the industry, as well as other additional benefits are a matter of course for us, including pension scheme, paid vacation days and flexible working time.
• The salary range for this position is $161,300-$274,200.