Serialization Manager Jobs in Virginia (NOW HIRING)

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.

General Description:

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.

Responsibilities:

• 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

Quality & Compliance

• 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

Equipment & Lifecycle Management

• 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

People Leadership

• 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

Continuous Improvement

• Drive improvements in:

  • OEE / uptime

  • Yield and Right First Time

  • Changeover efficiency (critical for high-mix environment noted in project discussions)

Experience & Skills Required:

• 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.

Experience & Skills Preferred:

• Startup or facility build experience preferred.

• High-mix / low-volume manufacturing preferred.

• Lean / Six Sigma certification preferred.

Computer 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).

Other 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.

Travel: Up to 5% travel

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

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 accommodationsus@beonemed.com.