Manager, Molecule Packaging

Overview

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. The role leads daily production, ensures GMP compliance, and drives performance across safety, quality, delivery, and cost while providing people leadership 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.
• 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) and support QA on batch record review, deviations, CAPAs, and investigations.
• Maintain inspection readiness for 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 (bottle unscrambler, filler, capper, labeler, cartoner, serialization systems).
• Drive preventive maintenance coordination, 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).
• Manage staffing, training, and qualification requirements.
• Implement continuous improvement initiatives focused on OEE, uptime, yield, right‑first‑time, and changeover efficiency.

• 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.
• People leadership, direct supervision experience.
• Experience with deviations/CAPA/investigations.
• Ability to manage multiple complex priorities simultaneously under tight timelines.
• Advanced analytical problem‑solving and proactive decision‑making skills.
• Strong communication skills; ability to summarize and present project information clearly to management.

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

• 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 use standard office equipment for extended periods.

Up to 5% travel.

Salary Range: $ - $ annually. The role is eligible for a comprehensive benefits package including medical, dental, vision, 401(k), FSA/HSA, life insurance, paid time off, and wellness programs.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact