Senior Associate, Mech Pkg, Labeling & Serialization at Replimune Group in Framingham

Job description

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 c