ED/VP Commercial CMC North America

Job Title: Executive Director / Vice President, North America Commercial CMC 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 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. Job Summary: A unique opportunity is reporting to the SVP, Head of Global CMC, who will lead the commercial CMC Teams (PPQ, BLA, Launch, Commercial Manufacturing) for the North America customer base. This role will oversee the strategic and operational aspects of CMC to ensure the successful commercial development, validation and commercialization of large molecules, all while ensuring regulatory compliance and industry standards are met. This role demands strong CMO and external contract manufacturing management experience, along with a background in Late Stage/Commercial development and commercialization of biologics in Large Pharma and proven leadership in managing matrixed teams. Responsibilities:

• Leadership & Team Development:

Lead, mentor, and develop the commercial CMC teams, driving initiatives that align with the company's vision and mission. Inspire a culture of collaboration, accountability, and high performance. Establish strong collaboration with global Manufacturing to ensure the success of CMC teams for the validation, launch and commercialization of biologics. Accountable for the overall commercial portfolio of CMC projects for the North America client base.

• Client Relationship and Key Account Management:

Build and sustain long-term client relationships by understanding client needs, tailoring services, maintaining open communication, and consistently exceeding expectations.

• Business Strategy & Development:

Formulate and implement strategies across various business models, integrated solutions, market-specific approaches, and client insight analysis.

• Late Stage/Commercial Technical Capability Portfolio:

Spearhead the design and execution of process validation, process performance qualification and commercial manufacturing, ensuring the integration of CMC into broader company objectives.

• CMC Strategy & Execution:

Develop and lead commercial CMC strategies for commercial supply, ensuring alignment with corporate goals and regulatory requirements.

• CDMO Management:

Establish guidelines, select, and manage CDMOs for efficient and cost-effective project execution. This includes contract negotiations, project management, and performance evaluation.

• GMP Manufacturing & Process Scaling:

Oversee the enhancement and scaling of GMP manufacturing processes, ensuring they meet clinical and commercial supply needs while maintaining product quality and regulatory compliance.

• Cross-functional Collaboration:

Work closely with senior leadership and cross-functional teams to integrate CMC considerations into comprehensive product development plans. Identify risks proactively and implement mitigation strategies.

• Continuous Improvement & Excellence:
• Drive efforts to enhance excellence, streamline project progression, and ensure efficient CMC development stages.
• Industry Trends & Best Practices:

Stay updated on emerging trends, technologies, and best practices in CMC development to guide informed decision-making and strategic planning.

• Regulatory Liaison:

Serve as the company’s liaison with regulatory agencies, providing CMC expertise and support during regulatory submissions, inspections, and responding to inquiries.

• Qualifications:
• Educational Background:

Degree in Chemistry, Chemical/Biochemical Engineering, Pharmaceutical Sciences, or a related discipline. PhD is strongly preferred but not required.

• Experience:

Extensive experience (ideally 15+ years) in Large Pharma and CMOs is critical, with a strong background in CMO/external contract manufacturing. Proven track record managing large molecules, supply chain, and contractor management.

• Technical Proficiency:

Deep technical knowledge in CMC development and manufacturing, with the ability to advance clinical programs and achieve commercialization.

• Regulatory Expertise:

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