Manager, Small Molecule Packaging

BeiGene•Hopewell, VA

17h•Onsite

About The Position

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.

Requirements

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.
Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word, Outlook).
Demonstrates strong accountability, communication, and ability to build trust in a fast-paced, regulated environment

Nice To Haves

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

Responsibilities

Support startup, ramp-up, and commercialization of packaging operations at the Hopewell site
Contribute to site readiness for regulatory inspections and product launches
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, and Changeover efficiency (critical for high-mix environment noted in project discussions)