CMC Strategy Director for Small Molecule Programs

BeiGene, Ltd.; Hopewell (VA); On-site; USD 275,000 - 355,000; Full time

Benefits offered by this job

Medical, Dental, Vision benefits

401(k) matching

Paid Time Off

Job summary

BeOne Medicines Ltd. seeks a CMC Lead to drive strategy and execution of CMC development for multiple drug programs from clinical phases to regulatory submissions and commercialization.

You will act as the single-point accountability, coordinating internal and external capabilities, mitigating risks, and ensuring GMP-ready manufacturing for both drug substance and product. The role requires deep CMC expertise, cross-functional leadership, and a track record of successful IND/NDA filings, with

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.
• 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.

Responsibilities

• Develop and execute 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.

Skills

CMC leadership

Cross-functional leadership

Regulatory strategy

GMP manufacturing

IND/NDA submissions

Data-driven decisions

Communication skills

Education

Ph.D. in Pharmaceutical Sciences

MS/PharmD considered

Job description

BeOne Medicines Ltd. seeks a CMC Lead to drive strategy and execution of CMC development for multiple drug programs from clinical phases to regulatory submissions and commercialization.

You will act as the single-point accountability, coordinating internal and external capabilities, mitigating risks, and ensuring GMP-ready manufacturing for both drug substance and product. The role requires deep CMC expertise, cross-functional leadership, and a track record of successful IND/NDA filings, with