Senior Director, Small Molecule Drug Product Manufacturing

Role: Senior Director responsible for overseeing small molecule drug product manufacturing operations, ensuring safety, quality, compliance, and delivery. Objectives include developing manufacturing strategies, supporting product launches, and maintaining inspection readiness. Responsibilities encompass leadership of manufacturing activities from formulation to packaging, managing capacity planning, technology transfer, validation, and continuous improvement initiatives. Ensures adherence to cGMP, FDA, EMA, and global regulations, leading quality systems and inspection preparedness. Drives operational excellence through lean methodologies, KPI management, and cost optimization while overseeing safety and environmental compliance. Manages manufacturing budgets, supports capital investments, and leads cross-functional collaborations across supply chain, quality, engineering, and regulatory teams. Technical oversight includes oral solid dosage processes, granulation, compression, encapsulation, coating, serialization, and warehouse operations. Qualifications: Bachelor's in Engineering, Sciences, or related field with 12+ years pharmaceutical manufacturing experience; advanced degrees preferred. Proven leadership in GMP operations of small molecule facilities, with expertise in facility startup, expansion, and regulatory inspections. Skilled in process validation, quality systems, and lean Six Sigma. Experience with global regulatory standards such as FDA, EMA, MHRA, and data integrity. Senior leadership experience managing diverse teams and strategic manufacturing initiatives. Travel up to 20%. High-value biopharma specifics: small molecule, oral solid dosage, regulatory compliance, GMP, validation, and continuous process improvement.