Replimune, Inc.

Associate II, Mechanical Packaging, Labeling & Serialization

Job Locations US-MA-Framingham
ID
2024-1557
Category
Supply Chain
Position Type
Regular Full-Time

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. We imagine a world where cancer is a curable disease.

 

At Replimune, we live by our values:

  

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.

 

Responsibilities

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

Qualifications

 

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.

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