Senior Associate, Mech Pkg, Labeling & Serialization

Replimune•Framingham, MA

12d•Onsite

About The Position

The Senior Associate, Mechanical Packaging, Labeling & Serialization is part of a cohesive team responsible for serialization of RPx products at Replimune’s Framingham facility. The role supports the Supply Chain team in planning, preparing, executing, and completing serialization processes in accordance with standard operating procedures, Good Manufacturing Practices, and safety policies and procedures. It also provides technical improvements, processes, materials, systems, troubleshooting support, and project leadership for packaging and labeling equipment associated with packaging serialization. The position supports day-to-day operations and is based in Framingham, with a typical five-day on-site expectation. The role requires relevant cGMP experience or an applicable biotech or engineering education and experience. The successful candidate will contribute packaging and equipment expertise, support process and technology improvements, work with internal stakeholders and vendors, document production activities, and follow procedures and safety requirements. The role involves handling hazardous materials and high-value products, lifting and moving objects up to 35 pounds, and standing for more than three hours.

Requirements

2 to 4+ years of cGMP experience, or a biotech certificate or associate degree, or a biotech/engineering bachelor’s degree with 0–2 years of experience.
Demonstrated basic math and communication skills.
Experience with vendor management.
Problem-solving skills, including anticipating and resolving complex problems.
Ability to work independently with minimal direction and collaboratively in teams.
Ability to lift up to 35 pounds and move heavy objects.
Ability to stand for more than three hours.
Ability to work with hazardous materials, such as isopropyl alcohol.
Ability to use computer-based systems for timecards, email, and inventory management.

Responsibilities

Serve as the subject matter expert for serialization packaging and shipping lines, supporting business system testing and validation activities.
Provide packaging engineering, equipment, and component expertise to improve costs and efficiencies and meet production targets for serialization activities.
Partner with internal stakeholders to implement DSCAA and country-specific requirements.
Develop and implement training metrics.
Manage the development and implementation of process improvements and technology upgrades to minimize costs and production issues.
Analyze operations, workflows, and packaging processes to develop solutions that maximize efficiency and reduce waste.
Share knowledge with manufacturing groups to incorporate ideas and resolutions for end-to-end execution.
Prepare presentations and technical reports.
Practice safe work habits and adhere to safety procedures and guidelines.
Complete activities in strict accordance with Standard Operating Procedures.
Document production activities in electronic systems, batch records, logbooks, or forms.
Follow operational procedures and written and verbal instructions from the manager or lead.
Identify and communicate process deviations to the manager.
Keep training up to date and retrain before expiration dates.
Safely handle high-value products in various stages of packaging completion.
Perform other duties as assigned.