Job Opportunity

Job Opportunity

Executive Director, US and EU CMC

Executive Director, US and EU CMC

United States Posted 2024-06-06

Executive Director CMC Management

WuXi Biologics is a 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 our PROUD culture of Passion, Reward, Opportunity, Unity, and Determination. WuXi Biologics offers exciting job opportunities and 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.

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

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.
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.

Preferred (but not required) Qualifications:

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 with staff management and/or CMC team management.
Ability to effectively work across all levels, functions, sites, and companies. Excellent verbal and written communication skills in both English and Chinese.
Experience in writing regulatory documents and submissions and the ability to work on multiple CMC projects at a time.

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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