VP, CMC Program Management

Role Summary

We are hiring a Vice President to lead our CMC Program Management team. This role coordinates Chemistry Manufacturing and Controls (CMC) activities across 80+ simultaneous programs within a rapidly growing biopharmaceutical pipeline, integrating efforts from R&D, process sciences, internal and external manufacturing, Quality Assurance, and Quality Control to ensure seamless product development, launches, and lifecycle management. The position aims to transform coordination processes into scalable frameworks and operate through influence and information orchestration with exceptional facilitation and systems-thinking skills.

Responsibilities

• 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.

Qualifications

• Required: Bachelor‚Äôs degree with 20+ years of progressive experience in biopharmaceutical CMC functions, with increasing analytical and strategic oversight responsibilities.
• Required: Deep technical experience in process development, analytical methods, manufacturing operations, and regulatory submissions.
• Required: Proven ability to identify acceleration opportunities and risk mitigation strategies that transcend individual functional perspectives.
• Required: Exceptional analytical skills to develop integrated plans and critically evaluate technical inputs from specialized teams.
• Required: Demonstrated success in facilitating cross-functional collaboration and influencing decision-making in matrixed environments.
• Required: Proven track record of optimizing coordination processes while ensuring regulatory compliance and quality standards.
• Required: Aptitude for process improvement and digital transformation, with a focus on automation opportunities.
• Required: Executive-level communication skills, capable of translating technical complexity into actionable strategic insights.
• Required: Experience leading cross-functional decision-making processes in environments with competing priorities and diverse organizational cultures.

Education

• Bachelor‚Äôs degree (required)