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: 

This role is responsible for generation and execution of stability protocols as per ICH guidelines. The role will also compile results, perform data trending and generate stability reports. In addition, the role is responsible for performing analysis within Quality Control.

This role also includes responsibility of QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP), managing or overseeing the work of more junior QC staff, setting up and maintaining systems for QC laboratory, assist with scheduling, reviewing of tests results, assist in the management of the QC laboratory, participation in assay transfer and validation activities.

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

• Generation and execution of stability studies as per ICH guideline
• Compile results, perform data trending using appropriate statistical techniques and generate stability reports.
• Perform QC testing following Standard Operating Procedures (SOPs).
• Assist with the maintenance of QC laboratory and equipment.
• Generate protocol and report for assay transfers/validation.
• Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Author and review SOPs, forms, Deviations, Change controls CAPA, CoA (Certificate of Analysis) reports
• Lead or assist with OOS, OOT, and lab investigations as needed.
• Participate in regulatory inspections and submissions, as needed.
• Lead QC Stability equipment introduction and participate in validation activities.
• Interact within internal as well as across other functional group to communicate QC requirements.
• Manage receipt and storage of QC samples, reagents and maintain retain inventory.
• Coordinate shipping of samples to Milton Park and contract testing laboratories.
• Training others within department for methods and processes according to GMP standards.
• Become SME/Trainer for method or process and lead troubleshooting or method optimization as required
• Line management responsibility for direct reports if applicable

Other responsibilities

• Manage technical studies performed with external companies.
• Represent QC at inter-departmental meetings and interact with external vendors, as necessary

Preferred Educational requirements:

• A BA or BS in Chemistry/Biochemistry/Microbiology or other related science.

Experience and skill requirement:

• 4 years or more GLP / GMP experience in a relevant work environment required.
• Computer literacy (including MS Word and Excel)
• Ability to work well with others
• Effective communication skills
• Good organizational skills

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. 

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