Manager, Small Molecule Packaging

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.

The Manager, Small Molecule Packaging is responsible for end-to-end execution of primary and secondary packaging operations at the Hopewell site, including bottle filling, cartoning, and serialization. This role leads daily production, ensures GMP compliance, and drives performance across safety, quality, delivery, and cost. The position provides people leadership, operational oversight, and continuous improvement to support reliable and inspection‑ready manufacturing.

• Support startup, ramp‑up, and commercialization of packaging operations at the Hopewell site
• Contribute to site readiness for regulatory inspections and product launches
• Operations & Production
• Lead day‑to‑day operation 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 (21 CFR / EU GMP referenced in master plan)
• Partner with QA on:
  • Batch record review
  • Deviations, CAPAs, and investigations
• Maintain inspection readiness (FDA / regulatory audits)
• Ensure proper serialization and traceability systems execution

• Support and own operational aspects of:
  • Commissioning, Qualification (IQ / OQ / PQ), and validation activities
  • Maintain systems in a validated state and support change control processes
  • Collaborate with Engineering, Automation, and Validation teams
  • Own performance of packaging equipment including:
    • Bottle unscrambler, filler, capper, labeler, cartoner, serialization systems
    • Drive preventive maintenance coordination and troubleshooting and root cause analysis
    • Act as system owner / process owner ensuring compliant operation

• Lead and develop cross‑functional team of operators, mechanics, and support staff in a GMP manufacturing environment
  • Build capability in GMP behaviors and aseptic/cleanroom discipline (Grade D environment noted in scope)
• Manage staffing, training, and qualification requirements

• Drive improvements in:
  • OEE / uptime
  • Yield and Right First Time
  • Changeover efficiency (critical for high‑mix environment noted in project discussions)

• Bachelor’s degree in Engineering, Life Sciences, or related field with 5+ years of GMP pharmaceutical packaging operations experience required.
• Master’s degree with 4+ years of GMP pharmaceutical packaging operations experience primary and secondary preferred.
• Experience with automated packaging lines / 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.

• Startup or facility build experience preferred.
• High‑mix / low‑volume manufacturing preferred.
• Lean / Six Sigma certification preferred.

• 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).

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

• Ability to work in an office environment, construction site, and laboratory or manufacturing areas.
• Must be able to sit, stand, and…