Senior Associate, Mech Pkg, Labeling & Serialization

Overview 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. At Replimune, we live by our values: United: We Collaborate for a Common Goal. Audacious: We Are Bold. 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, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves. Join us, as we reshape the future. Summary of job description: 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 production activities in electronic systems, batch records, logbooks, or forms. Follow operational procedures and both written and verbal instructions from the manager/lead. Other responsibilities: Other duties as assigned Educational requirements: 2 to 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. Experience and skill requirement: Experience with vendor management Problem solving 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. Ability to work in teams. Salary Range Replimune is committed to fair a…

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