Senior Packaging & Serialization Specialist

Replimune Group; Framingham (MA); On-site; USD 103,500 - 133,500; Full time

Job summary

Replimune is seeking a Senior Associate, Serialization & Packaging to join its Framingham, MA facility. You will support commercial packaging and serialization, ensuring quality and regulatory compliance while coordinating with the Packaging team.

The role requires hands-on experience with packaging and serialization systems, including Antares equipment and TraceLink platforms, and involves documentation, training, and continuous improvement in a fast-paced biotechnolgy setting.

Qualifications

• Experience with DSCSA compliance and serialization regulations.
• Knowledge of commercial packaging and serialization processes.
• Ability to train and mentor manufacturing staff.
• Experience with in-house packaging and serialization environments.
• Familiarity with Antares equipment and TraceLink platforms.

Responsibilities

• Support the execution of commercial packaging and serialization activities.
• Operate packaging lines, perform line clearances, troubleshooting, and shutdowns.
• Serve as SME for serialization processes including commissioning and reconciliation.
• Ensure activities align with batch records, SOPs, and GMP requirements.
• Monitor line performance and drive efficiency, quality, and compliance.
• Assist with distribution transfer to 3PL and product transfer activities.

Skills

DSCSA compliance

Serialization knowledge

Training & mentoring

GMP/cGDP knowledge

Problem-solving

Education

Associates Degree / Biotechnology Certificate / Bachelor's Degree in Life Sciences or related

2–4 years GMP environment experience

High School Diploma with pharma experience considered

Tools

Antares

TraceLink

Oracle ERP

Job description

Replimune is seeking a Senior Associate, Serialization & Packaging to join its Framingham, MA facility. You will support commercial packaging and serialization, ensuring quality and regulatory compliance while coordinating with the Packaging team.

The role requires hands-on experience with packaging and serialization systems, including Antares equipment and TraceLink platforms, and involves documentation, training, and continuous improvement in a fast-paced biotechnolgy setting.