Senior Director, Small Molecule Drug Product Manufacturing

BeiGene•Hopewell, VA

7d•Onsite

About The Position

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: The Senior Director is responsible for the overall leadership, performance, and regulatory compliance of the Small Molecule Drug Product Manufacturing facility. This role has full accountability for Safety, Quality, Delivery, Cost, and People across all manufacturing 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 is accountable for maintaining a state of inspection readiness and ensuring compliance with all FDA, EMA, and global regulatory expectations.

Requirements

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.
Member of Site Leadership Team.
Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, Life Sciences, or related discipline and 12+ years of pharmaceutical manufacturing experience required.
10+ years of progressive leadership experience in GMP pharmaceutical operations.
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.
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

Nice To Haves

Master’s degree and 8+ years of experience preferred
MBA desirable

Responsibilities

Influence manufacturing strategy and network planning.
Partner with cross functions 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, 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.