Manufacturing Specialist I - Replimune, Inc.

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 becausepatient’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 tothe meaningful work we do which could impact the lives of patients.  

 Join us, as we reshape the future. 

Job Summary: 

The Manufacturing Specialist I and II will be part of a cohesive team responsible for producing RPX at Replimune’s Framingham Manufacturing Facility. The Manufacturing Specialist uses expert knowledge of cGMP regulations and biopharmaceutical production processes to provide day to day operational support through the implementation of process improvements, leading manufacturing activities, supporting the scheduling of daily manufacturing activities and deviation/CAPA/change control writing with a focus on but not limited to Commercial/Clinical Manufacturing.

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

Key responsibilities:

• Practice and promote safe work habits and adheres to safety procedures and guidelines
• Utilize manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues, deviations, non-conformances, and unexpected events
• Lead cross-functional teams to drive complex investigation close-outs, determine root cause and implement appropriate corrective and preventive actions (CAPA)
• Drive continuous improvement by authoring and implementation change controls
• Conduct document revisions and/or document management including batch production records and manufacturing procedures
• Follow-up on requests, issues, and projects and report status to manager/working teams
• Work independently with minimal supervision and direction
• Perform work that consistently requires independent decision making and the exercise of independent judgment and discretion

Other responsibilities

• May perform metrics trending
• May generate technical protocols and reports
• May support internal and external audits

Education:    

• Bachelor's Degree with 5-8 years of experience in biopharmaceutical operations or a master’s degree with 0-2 years industry experience; Degree in Life Sciences or Engineering is preferred

 Required Experience:  

• Subject matter expertise in biologics drug substance manufacturing operations (liquid chromatography, TFF, aseptic technique) / Drug Product (Sterile Filtration, Filling, Inspection, Labeling, Freezing) or a similar complex specialized environment
• A comprehensive understanding of investigational techniques such as Fishbone/Ishikawa analysis, 5-Why, Kepner Tregoe
• A comprehensive understanding of regulatory requirements and their applications in a cGMP environment
• Minimum of 2 years’ experience with deviation/investigation management systems or a similar technical writing system in a cGMP environment
• Excellent written and oral English language skills
• Demonstrated ability to lead cross-functional teams and deliver results with minimal supervision
• Ability to manage multiple competing priorities in a fast-paced environment
• Thorough understanding of 21 CFR part 11 requirements
• Background in lean manufacturing methodologies and operational excellence
• Experience interacting with representatives of regulatory agencies
• Project management experience

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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