SM CMC Lead, Late Stage

• Develop and execute comprehensive CMC strategies aligned with overall development objectives and corporate goals.
• Lead CMC planning and execution across development stages, including pivotal clinical development, registration submission, commercial manufacturing readiness, post-approval lifecycle management.
• Define critical CMC milestones, deliverables, timelines, resource needs, and risk mitigation strategies.
• Provide strategic oversight of drug substance and drug product development activities. Ensure processes are scientifically sound, robust, scalable, and suitable for GMP manufacturing. Partner with CDMOs and manufacturing sites to ensure successful execution of clinical and commercial supply.
• Ensure appropriate analytical strategies are established to support product development and regulatory requirements. Ensure analytical packages support regulatory submissions and lifecycle management.
• Partner with Regulatory Affairs to develop high-quality CMC regulatory strategies. Support preparation of regulatory briefing packages, responses to agency questions, and commitments.
• Establish effective governance mechanisms for CMC decision-making. Lead technical assessments and trade-off decisions balancing quality, speed, cost, regulatory expectations, and long-term commercial needs.
• Identify CMC risks and establish mitigation plans throughout development.
• Provide strategic oversight of CDMOs and external vendors. Ensure external partners deliver against agreed scope, timelines, quality standards, and budgets. Lead escalation management when needed.
• Support transition from development to commercial manufacturing. Ensure CMC readiness for PPQ campaigns, Regulatory submission/inspections, launch supply, and post-approval changes.
• Develop lifecycle strategies to improve product robustness, cost, capacity, and supply reliability.

• Serve as the primary CMC representative on cross-functional development teams.

• Lead collaboration among all CMC technical functions, commercial manufacturing, QA/QC, regulatory CMC, clinical development, supply chain, external CDMO partners, etc.
• Ensure effective communication, alignment, and decision-making across functions.

• Drive resolution of complex technical and operational challenges.

Required Qualifications

• Ph.D. or equivalent degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, or related discipline preferred.
• Advanced degree (MS/PharmD) with extensive pharmaceutical industry experience may be considered.
• 12+ years of pharmaceutical/biotechnology industry experience in CMC development.
• Demonstrated experience leading CMC activities for NCE through clinical development and regulatory approval.
• Experience supporting successful IND and NDA submissions.
• Strong understanding of CMC development, GMP manufacturing, and regulatory CMC expectations.
• Proven ability to lead cross-functional teams without direct authority.
• Strong strategic thinking and problem-solving capability.
• Ability to make data-driven decisions under uncertainty.
• Excellent communication skills with technical, executive, and regulatory stakeholders.

Preferred Qualifications

• Experience leading multiple pipeline programs simultaneously.
• Experience managing both internal and outsourced development/manufacturing models.
• Experience with global regulatory agencies (FDA, EMA, NMPA).
• Experience with commercialization, technology transfer, PPQ, and post-approval lifecycle management.
• Experience building CMC organizations or implementing CMC governance models.

Key Success Metrics

• Delivery of CMC milestones according to program timelines.
• Successful IND/NDA submissions and regulatory interactions.
• Robust clinical and commercial supply readiness.
• Effective management of CMC risks and external partners.
• Strong collaboration across development functions.
• Development of scalable, cost-effective, and compliant manufacturing processes.

, quality expectations, and business objectives.

The successful candidate will provide strong scientific and operational leadership, integrate internal and external CMC capabilities, proactively identify technical risks, and enable efficient delivery of high-quality drug substance and drug product to support clinical and commercial success.

Key