Manager, Small Molecule Packaging

Responsibilities

• Support startup, ramp-up, and commercialization of packaging operations at the Hopewell site
• Contribute to site readiness for regulatory inspections and product launches
• Operate and lead day-to-day production of bottle filling, capping, labeling, cartoning, and case packing processes
• Ensure packaging line meets throughput, schedule, and quality targets
• Manage line performance across primary and secondary packaging workflows
• Oversee line readiness, batch execution, and line clearance activities
• Ensure all operations comply with cGMP requirements and partner with QA on deviations, CAPAs, and investigations
• Maintain inspection readiness and ensure proper serialization and traceability systems execution
• Support and own operational aspects of commissioning, qualification, and validation activities
• Drive improvements in OEE, uptime, yield, and changeover efficiency

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field with 5+ years of GMP pharmaceutical packaging operations experience
• Master’s degree with 4+ years of GMP pharmaceutical packaging operations experience preferred
• Experience with automated packaging lines and serialization required
• People leadership, direct supervision required
• Experience with deviations/CAPA/investigations required
• Proven ability to manage multiple complex priorities simultaneously under tight timelines required
• Analytical problem-solving skills and proactive decision-making required
• Ability to summarize and present project information clearly to management required

Skills

• Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word, Outlook)
• Experience with project management tools such as Microsoft Project, AutoCAD, Smartsheet
• Familiarity with data management and visualization tools (e.g., SharePoint, Teams, Power BI)
• Comfortable working within document management systems (e.g., Veeva Vault, eQMS, or similar)

Qualifications

• Demonstrates strong accountability, communication, and ability to build trust in a fast-paced, regulated environment

Physical Requirements

• Ability to work in an office environment, construction site, and laboratory or manufacturing areas
• Must be able to sit, stand, and use standard office equipment for extended periods

Benefits

• Medical, Dental, Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness