VP, CMC Program Management

We are hiring a Vice President to lead our CMC Program Management team. This position addresses a critical organizational challenge: coordinating Chemistry Manufacturing and Controls (CMC) activities across 80+ simultaneous programs within a rapidly growing biopharmaceutical pipeline. The role requires integrating efforts from specialized teams—R&D, process sciences, internal and external manufacturing, Quality Assurance, and Quality Control—each operating under distinct organizational structures. Success in this role will ensure seamless product development, launches, and lifecycle management.

This position is a unique opportunity to transform current coordination processes into scalable frameworks that enable a growing and complex portfolio. Operating through influence and information orchestration rather than direct functional authority, the role demands exceptional facilitation skills and a systems-thinking approach to complex organizational dynamics.

In this role, a typical day might include the following:

• Strategic Coordination and Process Transformation

  • Develop systematic frameworks to address coordination breakdowns, enabling scalable information flows and decision-making processes.

  • Establish communication rhythms, action plan reviews, and escalation protocols to improve pipeline velocity and launch timeliness.

  • Identify and implement digital tools to automate and enhance coordination workflows.

• Cross-Functional Collaboration

  • Facilitate integration across R&D, manufacturing, regulatory, and quality teams to ensure alignment on timelines, resource allocation, and risk mitigation.

  • Provide technical input and foster collaboration through credibility and influence rather than direct authority.

• Performance Optimization

  • Identify bottlenecks and implement solutions to accelerate launch predictability and execution success.

  • Develop comprehensive reporting frameworks to provide leadership with visibility into program status and emerging risks.

• Long-term Organizational Development

  • Build scalable coordination capabilities to support pipeline expansion and therapeutic modality diversification.

  • Capture and formalize best practices for program coordination across diverse program types and market requirements.

This role might be for you if you have:

• Deep technical experience in process development, analytical methods, manufacturing operations, and regulatory submissions.

• Proven ability to identify acceleration opportunities and risk mitigation strategies that transcend individual functional perspectives.

• Exceptional analytical skills to develop integrated plans and critically evaluate technical inputs from specialized teams.

• Demonstrated success in facilitating cross-functional collaboration and influencing decision-making in matrixed environments.

• Proven track record of optimizing coordination processes while ensuring regulatory compliance and quality standards

• Aptitude for process improvement and digital transformation, with a focus on automation opportunities.

• Executive-level communication skills, capable of translating technical complexity into actionable strategic insights.

• Experience leading cross-functional decision-making processes in environments with competing priorities and diverse organizational cultures.

To be considered for this role you must hold a Bachelor’s degree with 20+ years of progressive experience in biopharmaceutical CMC functions, with increasing analytical and strategic oversight responsibilities.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site.  Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations f