Executive Leader, Small Molecule Drug Product Manufacturing

BeOne Medicines; New Jersey; On-site; USD 180,000 - 240,000; Full time

Job summary

BeOne Medicines in New Jersey seeks a Senior Director to lead all small molecule manufacturing operations, ensuring safety, quality, and regulatory compliance across the site. The role reports to the Site Leadership Team and drives operational excellence, capacity planning, and continuous improvement.

You will oversee manufacturing strategy, technology transfer, validation, and risk management, coordinating with Quality, Supply Chain, Engineering, and EHS to maintain inspection readiness and

Qualifications

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Life Sciences, or related discipline.
• 12+ years of pharmaceutical manufacturing leadership experience.
• Experience leading facility startups, expansions, technology transfer, or commercialization.
• Proven track record in achieving regulatory inspection readiness.

Responsibilities

• Influence manufacturing strategy and network planning.
• Represent manufacturing in executive governance meetings.
• Provide strategic and operational leadership for all small molecule drug product manufacturing activities.
• Ensure delivery of production schedules while maintaining safety, quality, and compliance standards.
• Lead facility startup, expansion, technology transfer, validation, and commercialization initiatives.
• Develop and execute long-range manufacturing capacity and resource plans.
• Drive manufacturing performance through KPI management and operational reviews.
• Maintain strict adherence to cGMP, FDA, EMA, ICH, and corporate standards.
• Maintain inspection readiness across all manufacturing areas.
• Partner with Quality on deviations, investigations, CAPAs, changes, and risk assessments.
• Serve as primary manufacturing representative during regulator inspections and customer audits.
• Foster a culture of quality ownership and data integrity.
• Implement Lean Manufacturing, Six Sigma, and continuous improvement programs.
• Improve OEE, productivity, and throughput.
• Lead root cause investigations and corrective actions.
• Establish benchmarking and performance metrics.

Skills

Leadership

GMP

Regulatory compliance

Strategic planning

Cross-functional leadership

Lean Six Sigma

Operational excellence

Education

Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Life Sciences, or related discipline

Master's degree (preferred)

MBA desirable

Tools

MS Office

Job description

BeOne Medicines in New Jersey seeks a Senior Director to lead all small molecule manufacturing operations, ensuring safety, quality, and regulatory compliance across the site. The role reports to the Site Leadership Team and drives operational excellence, capacity planning, and continuous improvement.

You will oversee manufacturing strategy, technology transfer, validation, and risk management, coordinating with Quality, Supply Chain, Engineering, and EHS to maintain inspection readiness and