Director, CMC

Job Title - Director - Executive Director CMC Management

Work Location - West Coast (Preferably San Diego, Los Angeles, San Francisco, Seattle)

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. WuXi Biologics’ achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by ourPROUDcultureof Passion, Reward, Opportunity, Unity, and Determination.WuXi Biologicsoffers excitingjobopportunitiesand careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies..

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.
• 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

Qualifications

Preferred (but not required) Qualifications

Anticipated pay range for this position is $150,000 - $280,000

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

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