Senior Director, Small Molecule Drug Product Manufacturing

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:

• 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.

• 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%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.