Commercial Supply Chain Production Packaging Associate

Replimune Limited • Framingham, MA

294d

About The Position

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 which could impact the lives of patients. Join us, as we reshape the future.

Requirements

• High School Diploma / GED and 1 to 2 years of cGMP experience/ Biotech Certificate/ Associates Degree or bachelor's degree and 0 years of experience.
• Pharmaceutical or similar GMP environment experience.
• Experience with pharmaceutical processing equipment in GMP environment.
• Understanding of pharmaceutical serialization.
• Ability to work on the packaging activities with consistency and accuracy.

Responsibilities

• Responsible for the set-up, operation, shut down, and cleaning of all packaging and serialization rooms and production related equipment utilizing the highest standards within a cGMP environment, following SOPs.
• Complete all required associated documentation per Replimune SOPs ensuring accurate information is recorded.
• Ensure that all appropriate documentation and processes are completed per Replimune's SOPs, adhering to Good Manufacturing Practices.
• Ensure equipment set-up and packaging operation setup matches written requirements within operational Batch Documentation.
• Visually inspect drug product vials.
• Inspect the quality of cartons during production, packaging, and labeling.
• Immediately escalate all abnormalities, defects and quality issues when found.
• Monitor supply levels of packaging materials and replenish as needed.
• Ensure correct labeling and packaging of product in accordance with commercial serialization requirements.
• Move finished goods to designated area.
• Ensure efficient set up and organization of packaging and labeling rooms workstations.
• Keep the work area neat, clean, and organized.
• Responsible for loading, moving material, and operating serialization equipment.
• Work with ultra-low temperature requirements and handle product that is required to stay in temp of -70 degrees C using appropriate PPEs.
• Demonstrate safe work practices by wearing correct PPE and following safety policies.
• Demonstrate punctuality and adhere to work schedule.
• Demonstrate a Teamwork attitude by working well and effectively with others.
• Support regular cleaning and maintenance activities of the GMP areas and equipment.
• Demonstrate thorough knowledge and understanding of the Good Documentation Practices.
• Be a team player with accurate and effective communication abilities.

What This Job Offers

• Education Level: High school or GED