Sr. Associate, Mechanical Packaging, Labeling & Serialization - Replimune, Inc.

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. We imagine a world where cancer is a curable disease.

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United: We Collaborate for a Common Goal.

Audacious: We Are Bold and Innovative.

Dedicated: We Give Our Full Commitment.

Candid: We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do

Join us, as we reshape the future.

Job Summary:

Reporting to the Director of Commercial Supply Chain, the Senior Associate, Mechanical Packaging, Labeling & Serialization will be a part of a cohesive team responsible for the serialization of RPx products at Replimune’s Framingham facility.  The Senior Associate, Mechanical Packaging, Labeling & Serialization will support the Supply Chain team in the planning, preparation, execution and completion of various serialization processes in accordance with SOP’s, Good Manufacturing Practices and Safety policies/procedures. This role will also provide technical improvements, processes, materials, systems, troubleshooting support and project leadership for the packaging, labeling equipment associated with packaging serialization.  The Senior Associate, Mechanical Packaging, Labeling & Serialization will support day-to-day operations.

This position is based in our Framingham location and typically has a 5-day on-site expectation.

Key responsibilities:

• Serves as the subject matter expert (SME) for serialization packaging and shipping line by supporting business system testing and validation activities
• Provides packaging engineering, equipment and component expertise to improve costs, efficiencies and meets production targets with regards to serialization activities
• Partners with internal stakeholders to implement various DSCAA and country specific requirements
• Develops and implements training metrics
• Manages the development and implementation of process improvements and technology upgrades that help with minimizing costs and production issues
• Analysis of operations, workflows and packaging process to provide solutions to maximize efficiency and reduce waste
• Knowledge sharing with manufacturing groups to incorporate ideas and resolutions for end-to-end execution
• Prepare presentations and technical reports
• Practice safe work habits and adheres to safety procedures and guidelines
• Complete activities in strict accordance with Standard Operating Procedures
• Document duction activities in electronic systems, batch records, logbooks, or forms
• Follow perational procedures and both written and verbal instructions from the manager/lead

Additional Skills/Preferences:

• Experience with vendor management
• Problemsolving skills – anticipates and resolves complex problems
• Ability to work independently and with minimal direction
• Ability to lift to 35 lbs. and move heavy objects
• Ability to stand for greater than 3 hours
• Identify and communicate process deviations to the manager
• Keep all training up to date and retrain prior to the expiration date
• Work with hazardous materials (e.g., Isopropyl Alcohol).
• Routinely and safely handle high-value products in various stages of packaging completion.
• Use computer-based systems for timecards, e-mail, and inventory management
• Other duties as assigned that are deemed relevant to the position

Educational requirements:

• 2-4+ years of cGMP experience/ Biotech Certificate/ Associates Degree or biotech / engineering bachelor’s degree and 0 -2 years of experience.
• Demonstrated basic math skills and communication skills.
• Ability to work in teams.