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 which could impact the lives of patients. Join us, as we reshape the future. Job Summary: This role includes responsibility for 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 the QC laboratory, assisting with scheduling, reviewing test results, and participating in assay transfer and validation activities. This position is based in our Milton Park location and typically has a 5-day on-site expectation. Responsibilities
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 laboratory equipment introduction and participate in validation activities. Interact within internal as well as across other functional groups 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. Train others within the 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. Qualifications
Preferred Educational requirement: 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. #LI-Onsite
#J-18808-Ljbffr
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 includes responsibility for 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 the QC laboratory, assisting with scheduling, reviewing test results, and participating in assay transfer and validation activities. This position is based in our Milton Park location and typically has a 5-day on-site expectation. Responsibilities
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 laboratory equipment introduction and participate in validation activities. Interact within internal as well as across other functional groups 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. Train others within the 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. Qualifications
Preferred Educational requirement: 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. #LI-Onsite
#J-18808-Ljbffr
