Manager Oral Solid Dosage (Mfg & Packaging)

KEY RESPONSIBILITIES

• Lead OSD manufacturing and packaging operations including granulation, compression, encapsulation, coating, and packaging activities
• Drive operational performance, capacity optimization, and throughput improvements to support customer demand and business growth
• Foster a strong culture of quality, compliance, accountability, and inspection readiness aligned with cGMP and FDA expectations
• Utilize KPIs and operational metrics to improve efficiency, productivity, and overall team performance
• Provide technical leadership and operational oversight for OSD processes and validation activities (IQ/OQ/PQ/PV)
• Lead investigations, deviations, root cause analysis, and CAPA implementation
• Partner cross-functionally with Quality, Engineering, Validation, Supply Chain, and Technical Services teams to achieve operational objectives
• Support capital projects, process improvements, and operational excellence initiatives
• Coach, mentor, and develop manufacturing teams while fostering engagement, collaboration, and accountability
• Support budget management and operational decision-making with strong business and financial acumen

POSITION QUALIFICATIONS

• Bachelor’s Degree in Engineering, Pharmaceutical Sciences, or related discipline required; Lean Six Sigma a plus
• 10+ years of pharmaceutical manufacturing experience, including significant OSD operations experience
• Leadership experience within a pharmaceutical manufacturing or CDMO environment
• Strong knowledge of cGMP regulations, FDA 21 CFR Parts 210/211, and inspection readiness practices
• Technical expertise in oral solid dosage manufacturing and packaging operations
• Proven ability to lead teams, improve operational performance, and drive continuous improvement
• Strong leadership, communication, organizational, and problem-solving skills