CMC Strategy Director — Drug Substance & Product

BeOne Medicines Ltd.; Pennington (NJ); On-site; USD 180,000 - 260,000; Full time

Job summary

BeOne Medicines Ltd. seeks a CMC Lead to drive development strategy and execution for assigned programs from clinical through regulatory submission and commercialization.

You will be the single accountable point for CMC program governance, aligning development, manufacturing readiness, regulatory expectations, quality standards, and business goals. You will lead cross-functional teams, manage external CDMOs, identify risks, and ensure robust, scalable GMP‑compliant drug substance and drug

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.
• 8+ years of pharmaceutical/biotechnology industry experience in CMC development.
• Experience leading CMC activities for NCE through clinical development and regulatory approval.
• Experience supporting IND/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.

Responsibilities

• Develop and execute comprehensive CMC strategies aligned with development objectives and corporate goals.
• Lead CMC planning and execution across development stages, including clinical development and regulatory submissions.
• Define CMC milestones, deliverables, timelines, resources, and risk mitigation.
• Provide strategic oversight of drug substance and drug product development activities for GMP manufacturing.
• Ensure analytical strategies support regulatory submissions and lifecycle management.
• Partner with Regulatory Affairs to develop CMC regulatory strategies and responses.
• Establish governance for CMC decision-making and lead trade-off analyses.
• Identify CMC risks and implement mitigation plans throughout development.
• Manage CDMOs and external vendors to meet scope, timelines, and budgets.
• Support transition to commercial manufacturing and readiness for PPQ and inspections.

Skills

CMC leadership

Strategic thinking

Cross-functional leadership

Regulatory liaison

Data-driven decision making

Communication skills

Risk management

Project management

Education

Ph.D. in Pharmaceutical Sciences

MS/PharmD consideration

Job description

BeOne Medicines Ltd. seeks a CMC Lead to drive development strategy and execution for assigned programs from clinical through regulatory submission and commercialization.

You will be the single accountable point for CMC program governance, aligning development, manufacturing readiness, regulatory expectations, quality standards, and business goals. You will lead cross-functional teams, manage external CDMOs, identify risks, and ensure robust, scalable GMP‑compliant drug substance and drug