Vice President, Global Manufacturing & Commercial CMC Strategy

Career Opportunities: Vice President, Global Manufacturing & Commercial CMC Strategy (5655)

Requisition ID 5655 - Posted 09/10/2026 - Work From Home - United States

Job Title

Vice President, Global Manufacturing & Commercial CMC Strategy

Company

WuXi Biologics

Location

MA, USA

Reporting Line

This position has a dual reporting relationship to:

• Head of Global CMC
• Head of Global Manufacturing, US & APAC

Travel Requirement

Approximately 30% to 50% international and domestic travel

The position is based in MA, U.S., but has significant global responsibilities. The incumbent will directly lead a manufacturing organization located outside the United States and will travel regularly across WuXi Biologics' global network to support manufacturing execution, customer engagement, U.S. manufacturing capability development, regulatory readiness, leadership development, and other strategic initiatives.

Position Summary

The Vice President, Global Manufacturing & Commercial CMC is a senior leadership role with shared accountability across Commercial CMC and Global Manufacturing. The position is responsible for connecting commercial opportunity conversion with strong CMC strategy, disciplined program execution, reliable manufacturing delivery, regulatory readiness, and long-term organizational capability building.

Approximately 50% of the role will focus on Commercial CMC, namely on leading and supporting business development initiatives from a strong CMC technical perspective to attract new commercial opportunities. Special focus will be on potential new key accounts, i.e., target companies with whom there is a significant opportunity to grow the business. The Vice President will partner closely with Business Development, CMC, Program Management, Manufacturing, Quality, Regulatory Affairs, Supply Chain, Engineering, and other functions to support the conversion of late-stage and commercial opportunities into awarded programs and successful delivery. The incumbent will support senior CMC leadership throughout customer engagement, technical due diligence, proposal development, program planning, and execution governance.

The remaining 50% of the role will focus on Manufacturing Leadership. The Vice President will directly lead a manufacturing organization and will be accountable for production delivery, operational performance, organizational effectiveness, workforce development, and manufacturing capability improvement. The incumbent will develop a comprehensive understanding of WuXi Biologics' global manufacturing systems, operating model, and site capabilities, and will lead the manufacturing team in strengthening execution discipline, improving delivery performance, and supporting late-stage and commercial manufacturing programs.

While based in Massachusetts, this role has significant global responsibilities. The Vice President will serve as a key bridge between global manufacturing operations and the U.S. organization, facilitating the transfer of knowledge, operating practices, technical capabilities, and leadership experience across regions. The incumbent will partner with U.S. site and functional leadership teams to optimize and build the U.S. manufacturing operating system as the organization progresses toward sustainable commercial operations.

The Vice President will also play a key leadership role in preparing the U.S. manufacturing organization for its first Pre-License Inspection, or PLI, and in establishing sustainable inspection readiness. In addition, the position will lead global initiatives to assess manufacturing talent, identify critical capability gaps, establish succession and development plans, and build a pipeline of globally capable manufacturing leaders.

Success in this role requires the ability to operate effectively within a dual-reporting and highly matrixed global organization, balancing commercial priorities, CMC strategy, manufacturing execution, regulatory expectations, organizational development, and long-term business needs.

Key Responsibilities

1. Commercial CMC Leadership and Opportunity Conversion

• Serve as a senior CMC leader in the assessment, development, and conversion of late-stage and commercial business opportunities.
• Partner with Business Development and client-facing teams to understand customer needs, define differentiated CMC solutions, and strengthen the company's technical and manufacturing value proposition.
• Represent CMC and Manufacturing in customer meetings, technical due diligence, capability presentations, proposal development, and commercial discussions.
• Translate customer and product requirements into integrated CMC strategies, manufacturing plans, resource requirements, timelines, and risk-mitigation approaches.
• Evaluate the technical feasibility, manufacturing fit, development pathway, regulatory requirements, capacity needs, and execution risks associated with potential commercial programs.
• Lead cross-functional alignment among CMC, Manufacturing, Quality, Regulatory Affairs, Program Management, Supply Chain, Engineering, and other relevant functions.
• Ensure that commercial proposals appropriately balance customer requirements, technical feasibility, manufacturing capabilities, execution risk, resource availability, capacity, and business value.
• Support commercial negotiations by providing clear technical assessments, delivery assumptions, risk considerations, and recommended execution strategies.
• Strengthen customer confidence through credible technical leadership, transparent communication, and practical problem-solving.
• Support the effective transition of awarded opportunities from business development into structured program execution, with clear ownership, governance, milestones, and decision rights.

2. Commercial CMC Strategy / Program Execution and Delivery

• Lead the initiative and support senior CMC leadership for selected late-stage and commercial programs from opportunity conversion through technology transfer, process validation, PPQ, regulatory approval, launch, and routine commercial supply.
• Ensure that customer commitments are translated into executable CMC and manufacturing plans with clearly defined scope, timelines, resources, responsibilities, and interdependencies.
• Establish effective cross-functional governance to support timely decision-making, risk escalation, issue resolution, and clear accountability.
• Monitor critical program milestones, technical deliverables, manufacturing readiness, resource requirements, and delivery risks.
• Partner with Program Management and functional leaders to improve execution discipline, delivery predictability, communication quality, and cross-functional accountability.
• Identify technical, quality, operational, regulatory, supply, and organizational risks early and ensure that appropriate mitigation plans are developed and executed.
• Support the resolution of complex technical, quality, operational, and customer-related issues that may affect program delivery.
• Ensure alignment between customer expectations and the company's technical, manufacturing, and organizational capabilities.
• Promote strong lifecycle thinking, including long-term process robustness, supply reliability, comparability strategy, regulatory commitments, and post-approval change management.
• Capture lessons learned from program delivery and translate them into improvements in Commercial CMC and manufacturing execution processes.

3. Direct Global Manufacturing Leadership

• Directly lead a manufacturing organization. Assume accountability for the organization's safety, quality, delivery, productivity, cost, compliance, people development, and overall operational performance.
• Establish clear operating objectives, performance expectations, governance mechanisms, and accountability across the manufacturing organization.
• Lead the manufacturing team in executing technology transfer, engineering runs, process validation, PPQ, commercial launch, and routine production activities.
• Ensure that manufacturing plans are aligned with program priorities, technical requirements, workforce readiness, material availability, facility and equipment readiness, and available capacity.
• Build an effective operating rhythm that includes tiered performance management, daily management, risk reviews, resource planning, escalation, and cross-functional issue resolution.
• Drive reliable and right-first-time execution while maintaining full compliance with applicable quality, safety, and regulatory requirements.
• Strengthen collaboration among Manufacturing, Quality, CMC, Technical Operations, Engineering, Automation, Supply Chain, and Program Management.
• Build a culture in which risks and problems are identified early, escalated transparently, and resolved through data-driven and structured problem-solving.
• Develop a high-performing manufacturing leadership team capable of leading operations through scale-up, process validation, regulatory approval, commercial launch, and routine production.
• Provide coaching and development to manufacturing leaders and ensure that the organization has the technical depth, leadership capacity, and operational discipline required for future growth.

4. U.S. Manufacturing System Optimization & Global Network Integration

• Serve as a key bridge between WuXi Biologics' global manufacturing network and the U.S. manufacturing organization, ensuring effective knowledge transfer, capability development, and organizational alignment across regions.
• Partner with U.S. site and functional leadership teams to optimize and build a scalable manufacturing operating system capable of supporting validation, regulatory approval, commercial launch, and long-term commercial operations.
• Support the development of the U.S. manufacturing organization as it progresses from startup and qualification activities toward process validation, regulatory approval, commercial launch, and sustainable commercial operations.
• Leverage experience, expertise, and proven practices from mature manufacturing organizations across the global network to accelerate capability development within U.S. operations.
• Build leadership capability within the U.S. manufacturing organization by strengthening frontline leadership, middle-management effectiveness, and operational decision-making capabilities.
• Support the development of manufacturing standards, operating procedures, training systems, qualification processes, and competency frameworks required for a scalable and sustainable manufacturing organization.
• Support the establishment of robust manufacturing processes and systems required for technology transfer, process validation, PPQ execution, commercial launch, and routine GMP production.
• Promote the transfer and adaptation of global manufacturing best practices while ensuring alignment with U.S. regulatory requirements, customer expectations, and local operating conditions.
• Strengthen collaboration across manufacturing sites and global functions to improve organizational connectivity, execution consistency, and network effectiveness.
• Promote greater consistency in execution standards, manufacturing systems, leadership practices, governance processes, and performance expectations across the global manufacturing network while appropriately adapting to regional business and regulatory requirements.
• Build trusted relationships with site leaders, manufacturing leadership teams, and global functional stakeholders to enhance collaboration, organizational alignment, and execution excellence across the network.
• Help build a sustainable U.S. manufacturing organization capable of supporting future capacity growth, portfolio expansion, and long-term commercial supply commitments.

5. U.S. Regulatory and PLI Readiness

• Play a key leadership role in preparing the U.S. manufacturing organization for its first PLI and subsequent regulatory inspections.
• Partner with Site Leadership, Quality, CMC, Regulatory Affairs, Manufacturing, Engineering, Technical Operations, and other functions to define and execute an integrated inspection-readiness plan.
• Ensure that manufacturing operations, personnel, facilities, equipment, systems, documentation, and governance are prepared to demonstrate sustainable GMP readiness.
• Establish clear inspection-readiness milestones, ownership, escalation mechanisms, and management review processes.
• Lead or support manufacturing-related readiness assessments, mock inspections, gap remediation, process walkthroughs, and management reviews.
• Ensure that manufacturing leaders and subject matter experts understand their responsibilities and are prepared to communicate clearly and effectively during regulatory inspections.
• Support the development of evidence-based inspection narratives that demonstrate appropriate process understanding, control strategy, operational discipline, and state of control.
• Support regulatory interactions, inspection responses, commitments, and follow-up actions as required.
• Ensure that inspection-readiness gaps are addressed through sustainable improvements rather than short-term corrective actions.
• Translate inspection findings and lessons learned into broader improvements across the U.S. manufacturing organization and global manufacturing network.
• Reinforce a culture of continuous inspection readiness rather than one-time inspection preparation.

6. Matrix Leadership and Stakeholder Management

• Operate effectively within a dual-reporting structure and maintain strong alignment between the Head of Global CMC and the Head of Global Manufacturing, US & APAC.
• Establish clear alignment on priorities, objectives, resource requirements, performance expectations, and decision rights.
• Balance Commercial CMC priorities, customer commitments, manufacturing realities, regulatory expectations, and long-term organizational capability needs.
• Establish transparent governance, decision-making, communication, and escalation processes across organizational boundaries.
• Build trusted relationships with customers, site leaders, global functions, regional teams, and executive leadership.
• Communicate complex technical, operational, organizational, and commercial matters clearly, including risks, trade-offs, decisions, and recommended actions.
• Demonstrate enterprise leadership by making decisions that support the broader interests of WuXi Biologics and its clients.
• Promote collaboration between CMC and Manufacturing and ensure that commercial strategy is supported by realistic and executable manufacturing plans.
• Maintain appropriate transparency with both reporting leaders regarding objectives, performance, emerging risks, resource constraints, and major decisions.

Qualifications

Education

• Master's degree or Ph.D. in Life Sciences, Chemical Engineering, Biochemical Engineering, Biotechnology, or a related discipline.
• A bachelor's degree with extensive and directly relevant biopharmaceutical industry and senior leadership experience may also be considered.

Professional Experience

• Minimum 15 years of experience in the biopharmaceutical industry.
• At least 10 years of progressive leadership experience in CMC, Manufacturing, Technical Operations, Process Development, or related functions.
• Demonstrated experience supporting late-stage development and commercial biologics programs.
• Proven experience translating customer, product, and technical requirements into executable CMC and manufacturing strategies.
• Significant experience directly leading manufacturing teams and driving measurable improvements in operational performance and delivery.
• Strong knowledge of technology transfer, process characterization, process validation, PPQ, commercial launch, and routine commercial manufacturing.
• Experience supporting complex biologics programs in a regulated GMP manufacturing environment.
• Experience preparing for or directly supporting major regulatory inspections, preferably including PLI, FDA, EMA, or other global regulatory authority inspections.
• Demonstrated success leading complex, cross-functional programs within a global matrix organization.
• Experience working directly with clients and supporting business development, technical due diligence, proposal development, or commercial opportunity conversion.
• Experience building or optimizing manufacturing operating systems, organizations, and management processes.
• Experience working across multiple regions and cultures is required.
• Experience leading geographically dispersed teams or organizations is strongly preferred.

Global Leadership and Travel Requirements

• Demonstrated success leading teams located across multiple regions and cultures.
• Experience managing geographically dispersed manufacturing or technical organizations.
• Proven ability to lead a manufacturing organization located outside the leader's primary country of residence.
• Ability to establish strong leadership presence, team engagement, and execution accountability across geographic boundaries.
• Ability to operate effectively within a highly matrixed global environment and influence stakeholders across regions and functions.
• Ability to balance global responsibilities with local execution priorities while maintaining organizational alignment and delivering business results.
• Strong cultural awareness and the ability to adapt leadership and communication approaches across different countries and organizational environments.
• Ability to undertake extended international travel when required to address critical manufacturing, regulatory, customer, organizational, or leadership priorities.

Skills and Competencies

• Strong enterprise leadership and strategic thinking.
• Deep understanding of end-to-end biologics CMC development, commercialization, and lifecycle management.
• Strong manufacturing and operational leadership capability.
• Ability to connect commercial strategy, CMC requirements, technical feasibility, and manufacturing execution.
• Strong client-facing skills and commercial acumen.
• Proven ability to lead, engage, and develop high-performing manufacturing teams.
• Strong knowledge of global cGMP requirements and regulatory inspection-readiness expectations.
• Demonstrated ability to lead through influence in a complex global matrix organization.
• Strong program governance, risk management, prioritization, and decision-making capability.
• Ability to diagnose operational and organizational capability gaps and implement sustainable improvements.
• Strong talent-assessment, succession-planning, coaching, and leadership-development skills.
• Strong financial and business judgment, including the ability to balance service, risk, cost, capacity, and long-term capability needs.
• Excellent executive communication and stakeholder-management skills.
• Ability to communicate effectively with customers, regulatory authorities, technical experts, manufacturing teams, and senior executives.
• Sound judgment and the ability to balance short-term delivery requirements with long-term capability building.
• High standards of integrity, accountability, collaboration, quality, and customer focus.
• Demonstrated global mindset and commitment to developing diverse, internationally capable teams.

Key Measures of Success

Commercial CMC Impact

• Improved conversion of qualified late-stage and commercial opportunities.
• Stronger technical differentiation and increased customer confidence during the opportunity-conversion process.
• Effective translation of customer requirements into competitive and executable CMC and manufacturing strategies.
• Successful transition of awarded programs into structured execution.
• Improved governance, risk visibility, and delivery predictability for late-stage and commercial programs.

Manufacturing Delivery

• Reliable achievement of safety, quality, delivery, cost, productivity, and people objectives within the directly managed manufacturing organization.
• Successful execution of technology transfers, validation, PPQ, commercial launch, and routine manufacturing activities.
• Measurable improvement in operational discipline, right-first-time performance, issue resolution, and delivery reliability.
• Development of a strong manufacturing leadership team and a sustainable performance culture.
• Demonstrated improvement in manufacturing capability and organizational readiness for future commercial growth.

U.S. Manufacturing Capability

• Establishment of a scalable and effective U.S. manufacturing operating system.
• Measurable improvement in production planning, operating governance, frontline leadership, performance management, and execution capability.
• Successful transfer and local adaptation of relevant global manufacturing practices.
• Improved U.S. manufacturing readiness for PPQ, regulatory approval, commercial launch, and routine commercial operations.
• Stronger integration of the U.S. manufacturing organization with the global manufacturing network.

Regulatory Readiness

• Successful preparation of the U.S. manufacturing organization for its first PLI.
• Demonstrated operational, technical, documentation, and organizational readiness during regulatory inspections.
• Timely and sustainable closure of readiness gaps and inspection-related commitments.
• Establishment of a continuous inspection-readiness culture and management system.

About WuXi Biologics

WuXi Biologics is a leading global Contract Research, Development, and Manufacturing Organization, or CRDMO, providing end-to-end biologics solutions from discovery through commercial manufacturing. Through its globally integrated network, WuXi Biologics partners with biotechnology and pharmaceutical companies worldwide to accelerate development, support successful commercialization, ensure reliable supply, and maintain high standards of quality and regulatory compliance.

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