Senior Director, Small Molecule Drug Product Manufacturing

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.

Essential Functions of the Job:

• 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.
  

Manufacturing Leadership

• 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.
  

Quality & Compliance

• 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.
  

Operational Excellence

• 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.
  

Financial Management

• 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./
  

Technical Operations

• 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.
  

EHS Leadership

• 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.
  

People Leadership

• 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.
  

Supervisory Responsibilities:

• 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.
  

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook Word Excel PowerPoint).
  

Other Qualifications:

• Bachelors degree in Engineering Pharmaceutical Sciences Chemistry Life Sciences or related discipline and 12 years of pharmaceutical manufacturing experience required. (Masters degree and 8 years of experience preferred; MBA desirable).

• 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
  

Travel: Up to 20%

Global Competencies

When we exhibit our values of Patients First Driving Excellence Bold Ingenuity and Collaborative Spirit through our twelve global competencies below we help get more affordable medicines to more patients around the world.

• 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

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate including but not limited to job-related skills depth of experience certifications relevant education or training and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical Dental Vision 401(k) FSA/HSA Life Insurance Paid Time Off and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race religion color sex gender identity sexual orientation age disability national origin veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications merit and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Assistance Act of 1974 Title I of the Americans with Disabilities Act of 1990 and any other applicable federal state or local laws applicants who require reasonable accommodation in the job application process may contact .