Scientist I, Quality Control

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. Responsibilities

• Please Note: We are looking for a Scientist I with tissue culture experience and experience of potency assays in a QC GMP environment.Key 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 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 requiredLine management responsibility for direct reports if applicableOther responsibilities Manage technical studies performed with external companies. Represent QC at inter-departmental meetings and interact with external vendors, as necessary.

Education: A BA or BS in Chemistry/Biochemistry/Microbiology or other related science.Required Experience: 4 years or more GLP / GMP experience in a relevant work puter literacy (including MS Word and Excel)Ability to work well with othersEffective communication skillsGood organizational skillsAbout 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 . We are an Equal Opportunity Employer. #LI-onsiteJob SummaryID: 2026-1873Category: Quality, Regulatory Affairs & Medical WritingPosition Type: Regular Full-Time