Senior Director, Small Molecule Drug Product Manufacturing

BeOne seeks highly motivated, collaborative scientific and business professionals who share a passionate interest in fighting cancer to lead our Small Molecule Drug Product Manufacturing facility.

About the role

The Senior Director is responsible for the overall leadership, performance, and regulatory compliance of the manufacturing facility. This role has full accountability for Safety, Quality, Delivery, Cost, and People across all operations including dispensing, granulation, blending, compression, coating, encapsulation, packaging, warehousing, and associated support functions. As a key member of the Site Leadership Team, the Senior Director develops and executes operational strategies to ensure reliable supply of commercial products while driving operational excellence, continuous improvement, and organizational capability growth. The position maintains a state of inspection readiness and ensures compliance with all FDA, EMA, and global regulatory expectations.

Responsibilities

• Influence manufacturing strategy and network planning.
• Partner with cross-functional teams to support product launches and long-term capacity needs.
• 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.
• Ensure strict adherence to cGMP, FDA, EMA, ICH, and corporate quality standards.
• Maintain continuous inspection readiness across all manufacturing areas.
• Partner with Quality to oversee deviations, investigations, CAPAs, change controls, and risk assessments.
• Serve as primary manufacturing representative during regulatory inspections and customer audits.
• Foster a culture of quality ownership and data integrity throughout the organization.
• Implement Lean Manufacturing, Six Sigma, and continuous improvement programs.
• Improve OEE, productivity, batch cycle times, right-first-time performance, and manufacturing throughput.
• Lead root cause investigations and implementation of sustainable corrective actions.
• Establish benchmarking and performance metrics to drive operational excellence.
• Own manufacturing operating budget and financial performance.
• Manage labor, maintenance, materials, and operational expenditures.
• Identify and deliver cost savings initiatives while maintaining compliance and product quality.
• Support capital planning and execution for facility and equipment investments.
• Provide strategic oversight of oral solid dosage manufacturing, tablet compression, encapsulation, film coating, granulation and blending, dispensing operations, packaging and serialization, and warehouse and material handling operations.
• Support implementation of new technologies and manufacturing platforms.
• Ensure facilities and equipment remain qualified and operating within validated state.
• Promote a strong safety culture based on proactive identification and mitigation of risk.
• Ensure compliance with all safety, environmental, and occupational health requirements.
• Lead site EHS performance reviews and corrective action programs.
• Build, develop, and retain a high-performing manufacturing organization.
• Lead through coaching, succession planning, and talent development.
• Establish clear goals, accountability, and performance expectations.
• Foster collaboration across Manufacturing, Quality, Supply Chain, Engineering, Validation, Technical Services, and EHS.

Requirements

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, Life Sciences, or related discipline and 12+ years of pharmaceutical manufacturing experience required. (Master’s degree and 8+ years of experience preferred; MBA desirable).
• 10+ years of progressive leadership experience in GMP pharmaceutical operations.
• 10+ years of managerial experience directly managing people.
• Direct leadership of Manufacturing Managers, Production Supervisors, and Operations Leaders.
• Indirect leadership of production technicians, operators, warehouse personnel, and support functions.
• Demonstrated success managing commercial small molecule drug product manufacturing facilities.
• Experience supporting FDA, EMA, MHRA, PMDA, and other regulatory inspections.
• Proven leadership of facility startup, expansion, technology transfer, or commercialization activities.
• Demonstrated success driving operational excellence and productivity improvements.
• Strong PC literacy; MS Office skills (Outlook, Word, Excel, PowerPoint).

Skills

• Oral Solid Dosage (OSD) manufacturing
• Granulation technologies
• Compression and encapsulation operations
• Film coating processes
• Packaging and serialization systems
• Process validation and continued process verification
• Quality systems (Deviations, CAPA, Change Control)
• Supply Chain and S&OP processes
• FDA 21 CFR Parts 210/211
• EU GMP requirements
• Data integrity requirements
• Lean Manufacturing and Six Sigma methodologies

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Pay

Salary range: $200,500.00 - $270,500.00 annually. Actual compensation is determined by job-related skills, depth of experience, certifications, relevant education or training, and specific work location.

Benefits

• Annual bonus plan (non-commercial roles) or incentive compensation plan (commercial roles)
• Discretionary equity awards and voluntary participation in the Employee Stock Purchase Plan
• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance
• Paid Time Off
• Wellness programs

Schedule

Travel: Up to 20% globally.