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. 

Job Summary: 

The Commercial Supply Chain Packaging Associate will perform assigned functions at Replimune Framingham relevant to the packaging area ensuring that quality is maintained in products for the safety, well-being, and protection of the patient.  Employee will be required to perform assigned functions within Secondary Packaging Rooms (no exposed product), and in Primary Packaging Rooms (exposed product) when required.  The Commercial Supply Chain Production Packaging Associate is responsible for proper packaging of commercial products.

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

Responsibilities include but are not limited to:

• 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 SOP’s, 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
• Inspects the quality of cartons during production, packaging, and labeling
• Immediately escalates 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 labelling rooms workstations
• Keeps the work area neat, clean, and organized
• Responsible for loading, moving material, and operate serialization equipment
• Responsible for working with ultra-low temperature requirements and handling product that is required to stay in temp of -70degrees C using appropriate PPEs
• Demonstrates safe work practices by wearing correct PPE and following safety policies
• Demonstrates punctuality and adheres to work schedule
• Demonstrates a Teamwork attitude by working well and effectively with others
• Supporting regular cleaning and maintenance activities of the GMP areas and equipment
• Demonstrates thorough knowledge and understanding of the Good Documentation Practices 
• A team player with an accurate and effective communication abilities.

Education:   

• 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.

Required Experience:

• Pharmaceutical or similar GMP environment
• Pharmaceutical processing equipment in GMP environment
• Pharmaceutical serialization understanding
• Able to work on the packaging activities with consistency and accuracy

About Replimune  
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com. 

We are an Equal Opportunity Employer. 

#LI-Onsite