Replimune Jobs

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 is a strategic Commercial Supply Chain position within the Supply Chain function and is the accountable owner for developing and executing the commercial planning processes with the overall objective to evolve the function and ensure the success of future product launches. Success in this role will depend on an understanding of commercial demand planning, inventory management, supply planning, and new product launch as part of the overall planning process at a manufacturing site. In addition, daily management of business relationships between Replimune's 3PL, and couriers, and strong collaboration with multiple functions within Supply Chain (supply chain planning and warehouse logistics), Manufacturing and Commercial Operations across the organization as part of the overall Supplier Relationship Management process. This position is based in our Framingham location and typically has a 5-day on-site expectation. Responsibilities The Director of Commercial Supply Chain will be responsible for the serialization, packaging and labeling operations internally; capacity modelling to recommend scheduling strategies, future capacity needs, and capacity utilization strategies, working in conjunction with the Clinical Supply and Warehouse Supply teams to establish operating principles at the Framingham manufacturing site to ensure robust communication and alignment for capacity planning, slot allocation, and scheduling to support commercial product launches. Areas of Responsibility: Commercial Serialization, Packaging and Shipping Operations Leading and managing the entire packaging and labeling process, ensuring compliance with regulations and standards. Overseeing the operational aspects of commercial supply labeling, including serialization, label copy, draft labeling, proofreading, electronic and hard copy file maintenance, and distribution of approved materials Working knowledge of FDA regulations related to New Drug Applications, Good Manufacturing Practices, and Product Packaging and Labeling Develop, lead, and implement optimal packaging solutions along with ensuring proper testing and analysis to assess the packaging's performance, including durability, safety and environmental impact, globally Responsible for proper serialization coding, barcoding and GTIN numbers globally, per current regulations and standards Lead and manage technical transfers, validations and qualifications of new packaging processes Schedule and determine appropriate batch size and process improvements Manage day to day activities with commercial supply chain team Sales and Operations Planning (S&OP) Collaborate with the Clinical and Warehouse Supply Chain teams to establish the strategic production planning activities (long-term demand and supply planning) as the input for the strategic operational (CMO capacity planning) and procurement planning. Work closely with Commercial Operations to translate demand plans and market analytics into actionable and robust commercial supply plans as an output of S&OP. Work closely with 3PLs to ensure supply plan for commercial product is available based on demand planning. Work closely with Finance to align the monthly supply plan to financial considerations and metrics Responsible for developing, coordinating, prioritizing, and maintaining the S&OP commercial strategy, outlining the future state S&OP process and specific projects and initiatives within this area.Own and generate monthly commercial supply plans for internal cross-functional review and external supplier review. Own and manage monthly S&OP metrics development, implementation, monitoring, and reporting. Supplier Relationship Management (SRM) Work cross-functionally to develop targets for the commercial suppliers' metrics and KPI dashboards, working with a cross-functional team; to be utilized within existing Quarterly Business Reviews (QBR) and new Supplier Relationship Management governance process. Develop and Manage 3PLs business relationships monitor the performance of the suppliers, and serve as the primary point of escalation for risks and issues. Monitor and ensure 3PL adherence to contractual commitments, obligations, and processes, including milestone dates, financial terms, and production schedules both internally and externally. Manage budget responsibility for Supply Chain in the region, including logistics, supplier, and headcount expenses Develop a highly motivated and cohesive team that will accomplish long-term business objectives and prepare for future growth by identifying, recruiting, and retaining quality staff to support business growth Ensure all commercial supply chain activities comply with all applicable laws, regulations, GMP/GDP, and internal company policies. Qualifications Education: Bachelors Degree required, preferably in life sciences or business Required Experience: 7 - 15+ years of experience in a supply chain management role in an established biopharmaceutical company. Experience in leading and developing teams to deliver on organization growth initiatives. Experience in managing and implementing SRM and S&OP processes and leading cross-functional teams to overcome hurdles and deliver project results on time and as expected. International experience working with all organizational levels from multiple geographic lo

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 Technician 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 Technician 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 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. Qualifications Education: High School Diploma / GED 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 ****************** We are an Equal Opportunity Employer.

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 Join us, as we reshape the future. Job Summary: Reporting to the Director of Commercial Supply Chain, the Senior Associate, Mechanical Packaging, Labeling & Serialization will be a part of a cohesive team responsible for the serialization of RPx products at Replimune's Framingham facility. The Senior Associate, Mechanical Packaging, Labeling & Serialization will support the Supply Chain team in the planning, preparation, execution and completion of various serialization processes in accordance with SOP's, Good Manufacturing Practices and Safety policies/procedures. This role will also provide technical improvements, processes, materials, systems, troubleshooting support and project leadership for the packaging, labeling equipment associated with packaging serialization. The Senior Associate, Mechanical Packaging, Labeling & Serialization will support day-to-day operations. This position is based in our Framingham location and typically has a 5-day on-site expectation. Responsibilities Key responsibilities: Serves as the subject matter expert (SME) for serialization packaging and shipping line by supporting business system testing and validation activities Provides packaging engineering, equipment and component expertise to improve costs, efficiencies and meets production targets with regards to serialization activities Partners with internal stakeholders to implement various DSCAA and country specific requirements Develops and implements training metrics Manages the development and implementation of process improvements and technology upgrades that help with minimizing costs and production issues Analysis of operations, workflows and packaging process to provide solutions to maximize efficiency and reduce waste Knowledge sharing with manufacturing groups to incorporate ideas and resolutions for end-to-end execution Prepare presentations and technical reports Practice safe work habits and adheres to safety procedures and guidelines Complete activities in strict accordance with Standard Operating Procedures Document duction activities in electronic systems, batch records, logbooks, or forms Follow perational procedures and both written and verbal instructions from the manager/lead Additional Skills/Preferences: Experience with vendor management Problemsolving skills - anticipates and resolves complex problems Ability to work independently and with minimal direction Ability to lift to 35 lbs. and move heavy objects Ability to stand for greater than 3 hours Identify and communicate process deviations to the manager Keep all training up to date and retrain prior to the expiration date Work with hazardous materials (e.g., Isopropyl Alcohol). Routinely and safely handle high-value products in various stages of packaging completion. Use computer-based systems for timecards, e-mail, and inventory management Other duties as assigned that are deemed relevant to the position Qualifications Educational requirements: 2-4+ years of cGMP experience/ Biotech Certificate/ Associates Degree or biotech / engineering bachelor's degree and 0 -2 years of experience. Demonstrated basic math skills and communication skills. Ability to work in teams. We are an Equal Opportunity Employer. #LI-Onsite

The Director, Clinical Development/Clinical Scientist will report to the CMO or other senior member of the Clinical Development team to ensure the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners. The Director, Clinical Development will be accountable to jointly develop clinical program strategy and work collaboratively together with other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelines. The Director, Clinical Development will play a key role in the establishment and growth of Clinical Development functions to assure best-in-class global capabilities and execution. Specifically, the candidate will work closely with colleagues in clinical development, clinical operations, safety/pharmacovigilance, regulatory, biometrics, biomarkers and translational research, and program leadership. Responsibilities Facilitate and execute the generation, author, update, and/or review of key clinical and regulatory documents, including, but not limited to: Protocol concepts, synopses, protocols, and amendments Informed consent documents Investigator Brochures Clinical study reports Abstracts, posters and manuscripts Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports Risks / benefits analysis for applicable documents Clinical study supporting documentations and processes, g. charters for (independent) safety data monitoring or steering committee, study specific management plans and manuals, SOPs, etc. Instrumental to the Clinical Development Plan Generation and Program Strategy Primary contact and lead for all clinical and scientific aspects of the design, implementation, conduct, analysis, interpretation and documentation of clinical Partner with relevant functional areas for the successful implementation and execution of clinical studies. Specific tasks will include but are not limited to the following: Provide clinical and scientific expertise for selection of investigator and vendors Train internal colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs Review, query, and analyze clinical trial data Serve as medical monitor or partner with (senior) medical director on medical monitoring, patient eligibility and study treatment related questions, in cooperation with the CRO or directly with study investigator Interpret, and present clinical trial data, both internally and externally Create clinical study or program-related slide decks for internal and external use Represent a clinical study or development program on one or more teams or sub teams Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings, engage advocacy groups Contribute to or perform therapeutic area/indication research and competitor analysis Build strong relationships with internal experts. Identify continuous process improvement opportunities and help define/optimize standards and processes. Identify incremental organizational resource needs - staff, budget, and systems. Develop, track, execute and report on goals and objectives. Support budget planning and management. Be accountable for compliant business practices. Qualifications Educational requirements: MD, PharmD, or PhD within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required. Experience and skill requirement: Minimum of 10 years of experience and success within other biotech/pharmaceutical companies. Previous participation in a clinical development program is essential, including involvement in most stages of clinical trials (i.e. from start up to study report), ideally having taken at least one study through from start to finish in a clinical scientist or similar role. Clinical oncology experience; candidates with exceptional experience in other therapeutic areas would be considered if they demonstrated clear potential to apply their existing skills to oncology. Expert understanding of global clinical study design and drug development process from discovery to registration and post-marketing. High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills Knowledge of GCP and ICH Guidelines Flexibility to work with colleagues in a global setting Able to engage in work-related travel approximately 25% Demonstrated success in working in a cross-functional environment Experience with the development and support of related SOPs and policies is expected. Knowledge of industry standard Clinical Development IT solutions expected. Executive presence. Values based collaborator - respectful, accountable and collaborative. Ability to relate and work with a wide range of people to achieve results. Impactful written and verbal scientific communication. Successful and superior influencing skills across all levels of the organization and external collaborators. Problem solving and risk-mitigation skills. Confident, positive attitude, enthusiastic and charismatic. Appreciation of diversity and multiculturalism. Strategic and creative thinker. Ability to work independently and build working relations throughout the organization and with business partners to achieve business goals. Strong time management and organizational skills. Ability to manage multiple projects in a fast-paced environment. Skilled in multiple computer-based tools, in addition to software programs such as Word, PowerPoint, Excel, etc. must be able to travel as job requires which can vary (generally around 20+%)

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. Summary of job description: The Director, Biostatistics provides statistical leadership in one or more indications, including support of clinical development planning and execution for multiple clinical trials. Performs statistical analysis and develops tracking systems to determine the efficiency of clinical trials. Interacts with clinical development team to determine protocol design. Evaluates databases and statistical analysis programs. Maintains expertise in state-of-the-art data statistical methodologies and statistical analyses. At the project level, the individual in this role ensures the study designs are scientifically sound and that the efficacy and safety endpoints meet regulatory requirements. This position is based in our Woburn office and w elcomes hybrid work! Local candidates are expected to be on-site 3 days per week. Responsibilities Key responsibilities: Provide statistical support to clinical development plan for multiple clinical trials At study level, provide statistical input to study protocols, develop statistical analysis plan, and tables/listings/figures Assist in writing relevant sections of the clinical study report and publications Monitor and guide internal and CRO project activities including timelines, deliverables and resources Participate in pre-IND and NDA/BLA activities Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary. Develop and implement department standards and lead process improvements Other Responsibilities: Other duties as assigned Qualifications Education Requirements: PhD or MS in Biostatistics or Statistics required Experience and Skill Requirements: At least seven (7) years' experience for PhD, or nine (9) years' experience for MS as statistician in the pharmaceutical or biotechnology industry. Oncology (especially solid tumor) clinical trail experience preferred; knowledge of immuno-oncology is a plus. Experience with advanced study design and up-to-date biostatistical methodologies. Experience of NDA/BLA eCTDs or other global regulatory submissions. Experience of direct interaction with health authorities. Experience as an independent lead statistician with responsibility for multiple studies or projects. Excellent interpersonal, leadership and communication skills and ability to work independently and collaboratively. Good knowledge of statistical programming languages (including SAS). Knowledge of SDTM/ ADaM.

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. The Senior Maintenance Technician will provide comprehensive maintenance, repair and service for facilities, utilities, systems and equipment (FUSE) at the Framingham cGMP manufacturing facility. Areas of responsibility include, but are not limited to, advanced installation, troubleshooting, maintenance, repair, testing, and documentation of maintenance activities. Experience working within FDA regulated environments (cGMP) and Environmental Health and Safety (EH&S) guidelines are required. Excellent interpersonal and communication skills (verbal and written) are required. This is a second shift position and requires a self-starter with the ability to work independently. The Senior Maintenance Technician must be able to provide a wide range of support for both utility systems and process equipment during production activities. Shift schedule is Monday through Thursday, work hours are 2pm-12:30am (4 day, 10 hour shift). This position is based in our Framingham location. Responsibilities Routine and complex preventive maintenance and repair on a variety of process equipment, building systems, central utilities and facility components and structures in compliance with cGMP policies and procedures. In-depth and detailed maintenance work including installing, operating, and maintaining utility systems and equipment that support facility operations. These include HVAC systems, building management systems, chillers, boilers, emergency generators, compressed air, process gas distribution, pure water, WFI and clean steam systems. Support the installation, startup and maintenance of cGMP manufacturing process and support equipment, including but not limited to incubators, bioreactors, filtration equipment, filling equipment, controlled-temperature storage equipment, etc. Oversee outside vendors and contractors to ensure work is performed and documented in compliance with cGMP policies and procedures. Ensure that all in-house and vendor work activities are performed following EH&S guidelines. Rotating on call responsibilities to provide emergency support on an as needed basis. Qualifications Educational and training requirements: Massachusetts Grade II Industrial Wastewater license (Required) Post-secondary degree in a technical field or a technical trade school degree preferred. One or more of the following preferred: Massachusetts Journeyman Electrician Massachusetts Journeyman Plumber Massachusetts Refrigeration Technician EPA Refrigerant Recovery Type I, II, III or Universal Certification Massachusetts Fireman 2 nd Class License Experience and skill requirement: Minimum of 3-5 years' experience in a maintenance technician or equivalent role Experience working within biotech, pharmaceutical environment or other regulated environment required. GMP preferred. Strong technical knowledge and practical experience in instrumentation, manufacturing equipment, building mechanical systems, emergency backup power equipment, including: Biological and chemical waste management. Lock out/tag out program. Ability to understand and comprehend utility and system drawings. Working knowledge of automation software, PLC controllers, electrical motors, variable speed drives, pneumatic and gas systems. Understanding of qualification and/or validation of facility equipment and utilities. cGMP documentation - Facilities documentation (work orders, equipment files, calibrations, developing SOPs) and QA systems (CAPAs, deviations, change controls) Working knowledge of Microsoft Office (Word, Excel, Outlook, etc.) Familiarity with Computerized Maintenance Management System (CMMS) to record maintenance work activities

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 Director, HR Business Partner (HRBP) provides HR leadership and day-to-day support to leaders and employees in our Framingham, MA manufacturing facility. The Director will be responsible for a broad range of human capital matters, from employee relations and performance management to engagement and talent planning. The HR Business Partner is a resource to employees and managers and liaises with other internal functions when needed to bring solutions to clients. The Director, HR Business Partner will work a hybrid schedule: working three days/week in our Framingham location, with some additional time spent in our Woburn, MA corporate headquarters as needed. Responsibilities Manages the HR Business Partner day-to-day support and issue resolution for site teams - including but not limited to matters related to HR policies and business processes, employee relations, career development, performance management, learning and skill development, etc., to achieve key business and HR objectives Advises functional leaders in solving complex issues in all areas of human capital with a specific emphasis on employee relations, performance management, and talent acquisition to build a sustainable, high-growth organization Maintains the pulse of the people and drives effective employee engagement programs in alignment with our company culture, mission, vision, and values. Supports all efforts around employee engagement, ensuring follow up and action planning from annual employee survey. Motivates and supports employee engagement in a dynamic and high-growth collaborative culture. Builds strong partnerships with the HR specialist functions such as Talent Acquisition and Total Rewards to provide HR solutions to business needs and to support the roll out corporate-wide programs that enhance the overall employee experience and support growth and success of overall business strategy Works in coordination with the Talent Acquisition team to interview site candidates and facilitate the offer process with the manager as needed Identifies new approaches or process improvements to existing or non-existing business processes, policies, and/or procedures as it relates to the needs of a high-growth organization Provides support and guidance to employees when complex and sensitive questions and issues arise. Ensures compliance with all applicable labor laws, policies, and practices to maintain the highest standards of compliance and fairness. Partners with the HRBP team and managers on the year-end performance management process (performance assessment, calibration, and compensation planning). Leads strategic workforce planning efforts to ensure the people and talent strategy is in alignment with the organization's long range strategic plan (identification of long-term capability needs, talent acquisition and succession planning). Engages in larger HR or cross-functional projects, e.g., around wellness offerings, HR or business process improvements, talent attraction and retention strategies. Acts as an influencer and an integrator Qualifications Education: Bachelor's degree; Master's degree preferred Required Experience: 10+ years of broad Human Resources experience with significant exposure to employee relations, performance management, talent acquisition and other HR disciplines (e.g., training, benefits) 3+ years of experience in roles working directly with leaders as internal clients in an HR business partner capacity. Experience in the Biotech industry and/or within a lab or manufacturing environment strongly preferred; familiarity with operations functions also preferred. Thorough knowledge of HR best practices and employment-related laws and regulations Excellent verbal and written communication skills; interpersonal, negotiation, and conflict resolution skills Ability to effectively influence leaders and other stakeholders in an organization by demonstrating a high level of service, maturity, executive presence, and business acumen. Strong general knowledge of employee compensation, benefits, payroll, recruiting, performance management and training. Embraces the pace and opportunities of a fast-growing organization and has proven ability to handle a broad range of responsibilities; strong project management and prioritization skills to effectively drive multiple projects and initiatives. Possesses a high energy level, sense of urgency, ability to work hard and well under pressure and to effectively partner with the rest of the HR team. 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 ****************** We are an Equal Opportunity Employer.

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, caregivers and themselves. Join us, as we reshape the future. The Associate Director, Medical Writing, will provide writing assistance on various documents, including safety narratives, clinical study reports (CSRs), Development Safety Update Reports (DSURs), and other documents, as needed. This position will be responsible for coordinating the development of safety narratives (including drafting) and the compilation of the appendices for CSRs. The Associate Director, Medical Writing will coordinate the QC performed by external resources. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this position. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required. This position can be based either in our Woburn office (stronglyl preferred) or be a remote role Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require. Responsibilities Effectively partner cross-functionally in planning and preparation of high-quality clinical documents Work effectively with company document management system and related tools, templates and procedures in order to ensure efficient production of documents. Drives the process of development of clinical documents Contribute to the development of documents, which may include but are not limited to clinical study protocols and amendments, IBs, CSRs, DSURs, and other documents, as needed Summarize results presented in graphical, tabular, and/or listing format Manage several MW projects simultaneously, including oversight of external writers, and maintain timelines for document completion Coordinate document review and drive resolution meetings with cross-functional teams. Review, edit, and ensure quality of documents in collaboration with internal functional area representatives or external contractors, as needed Ensure document content and style complies with applicable regulatory requirements, SOPs, and company standards Ensure consistency within and across documents as appropriate, including but not limited to review of text, tables, and figures for accuracy, logic, and clarity of presentation Develop and/or update document templates, work instructions, style guides, and department-related processes (SOPs), and perform or support related training Ensure a consistent style of presentation of documents to maintain quality and ease of review May perform quality control (QC) reviews of clinical study documents as needed Works with relevant teams to obtain accurate information and data for written materials Provide teams a working knowledge of ICH guidelines and medical writing best practices Represent Medical Writing on a cross functional team Collaborate with and support the department leadership to ensure continuous improvement, and high standards for quality and productiveness. Qualifications Educational requirements: Degree in science or medical related field Master's degree or higher preferred Experience and skill requirement: Must thrive working in a fast-paced, innovative environment while remaining flexible proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills. Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system Ability to work both independently and collaboratively with a team in a geographically dispersed environment Demonstrated problem-solving ability, sense of urgency, and ability to prioritize tasks, to work simultaneously on multiple projects, and to independently complete high-quality documents according to timelines Experience in successfully resolving conflicting editorial opinions expressed by team members Strong team player that has a customer service approach and is solution oriented Attention to detail and the ability to work individually, within a multidisciplinary team, as well as with vendors Possesses strong written and verbal communication skills Background, Knowledge, And Experience Has a minimum of 5 years of medical writing experience (minimum of 1 year of experience for individuals with a PhD, PharmD, MD, or equivalent) Has a strong understanding of the fundamentals of clinical document development and documentation formatting within the industry Working knowledge of ICH and medical writing best practices is required Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology Understanding of the fundamentals of clinical development and regulatory affairs (e.g. from working in a similar or an adjacent group in industry) Proven ability of critical thinking, problem solving, and leading cross-functional teams Experience in oncology strongly preferred

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 Technician 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 Technician 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 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. Qualifications Education: High School Diploma / GED 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 ****************** We are an Equal Opportunity Employer.

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: Replimune is a fast-paced growing innovative company that has brought on-line a new production facility purposefully designed to manufacture our Oncolytic Immunotherapies. This multi-product facility in Framingham contains cGMP manufacturing suites, testing and development laboratories, warehousing and supporting utility spaces. Working in collaboration with cross functional teams, the Shipping Manager will be responsible for maintaining the warehouse and storage areas at the Replimune Framingham facility. The Shipping Manager will be responsible for maintaining procedures to support receipt of incoming goods, store space management, stocking and inventory of materials in the warehouse. The Shipping Manager will be responsible for overseeing the routine activities within the Warehouse and it is expected that the Shipping Manager maintains GMP compliance in the warehouse. This position is based in our Framingham location and typically has a 5-day on-site expectation. Responsibilities The Shipping Manager will be responsible for the transportation team in support of the Framingham manufacturing facility. The responsibilities of the Shipping manager include, but are not limited, to the following: Establishes Processes and Procedures for commercial shipping operations Work closely with Senior Manager and Director of Commercial Supply Chain on the scheduling of shipments to 3PL Ensure compliance with all outbound shipments including temperature sensitive shipments Provide training to employees and guidance to existing team members on a daily basis and improve transport operations. Maintain an accurate inventory of all controlled inventoried items and oversee the scheduling and packout activities for all shipments. Maintaining the warehouse and systems needed to enable packout requirements, inventory management, storage and supply of materials in support of outbound activities at the Framingham facility. Partner with different internal groups for scheduling and approval of all transport activities. Collaborate with Finance team to confirm sales order activities in the Oracle system. Organize Shipping team to properly distribute available workforce to other areas in the warehouse for support activities. Develop and maintain procedures for Commercial Shipping activities, including writing/reviewing SOPs. Initiate and own department Quality records including deviations, CAPA's, and Change Controls Collect and analyze key process and performance data points to facilitate continuous improvement and drive monthly metrics. Review and complete documentation in accordance with all Good Manufacturing Practices (cGMP). Inspect the physical conditions of the warehouse to ensure the maintenance of a clean, neat, and orderly workspace that complies with safety regulations, Occupational Safety and Health Administration (OSHA) and Safety Data Sheet (SDS) standards. Represent the Warehouse team at inter-departmental meetings and interact with external vendors as necessary. Develop and maintain a culture of continuous improvement within the department, evaluating performance and developing efficiency. Assist as subject matter expert for warehouse audits/inspections, as needed. Qualifications Education: Bachelor's Degree in Supply Chain, Business, or Management preferred or equivalent related experience Transportation Certifications (DOT/IATA) Required Experience: Minimum 3-5 years of experience in Material Handling, Shipping/Receiving and Warehouse coordination. 5 years of supervisory experience leading teams in a regulated environment. Experience with Temperature sensitive shipments, including frozen dry ice and cold shipments Experience with international shipping and understanding the requirements for different jurisdictions Experience with inventory management systems and control of inventory (SAP, Oracle) Computer literacy (including MS Word and Excel). Strong interpersonal skills with the ability to work with others in a positive and collaborative manner. Demonstrated ability to work accurately, meeting all timelines and handle multiple priorities, and work with sense of urgency. Excellent communication and 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

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 Principal Associate I/II, Plant Quality Assurance (PQA) reports to the Associate Director, Quality Assurance and is responsible for on-going Quality oversight to ensure real time quality oversight for Drug Substance, Drug Product, and all other production and QC testing activities according to current good manufacturing practices (cGMP), good documentation practices (GDP) and other applicable regulations. This position will be required to proactively support cGMP compliance and interact with all departments within the company. This position interacts with production staff and other cross functional groups routinely. This position is based in our Framingham location and typically has a 5-day on-site expectation. Responsibilities Key responsibilities: Serve as the second shift QA lead working alongside manufacturing teams to ensure current and best practices are implemented, consistently maintaining compliance with cGMP standards and keeping the plant in compliance with corporate and regulatory quality requirements. Perform Quality walkthroughs and inspections on the floor, to maintain inspection readiness environment. Review and approve executed production batch records, logbooks, and QC Assays. Drive closure/completion (including review and approve) of cGMP documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validation documentation. Author/review/approve quality documents, such as: standard operating procedures (SOPs), user requirements, risk assessments, training materials, engineering documents, automation documents, commissioning test protocols/reports, environmental qualification protocols/reports, validation protocols/reports. Conduct training on procedures, standard work, safety, and cGMP related topics. Other responsibilities Internal and external audit and inspection support as needed Assist with the implementation and continuous improvement of the Quality System. Other duties, as assigned Qualifications Education: BA or BS in a Science or related field or equivalent experience in the Quality function. Required Experience: 5-7+ years of experience in the pharmaceutical field including 5 years of years of Quality or Manufacturing experience Experience in managing multiple, competing priorities in a fast-paced environment. Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) Previous Quality Assurance oversight 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 ****************** We are an Equal Opportunity Employer. #LI-Onsite

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: We are seeking a motivated, detail-oriented Senior Associate to join the Supply Quality team. The successful candidate will assist with the implementation of GxP practices, Quality processes with specific emphasis on CMO labeling review, document control, and procedure revision and new procedure development. This role will require adaptability and eagerness to learn about all aspects of the Supply Quality processes to support relationships with internal stakeholders, contract manufacturing organization (CMO), suppliers, and clinical trial sites. The candidate will also interact cross-functionally with internal Quality Assurance, Quality Control, Clinical Operations, and Regulatory teams to ensure compliance to GxP processes and regulations. This position reports to the Director Supply Quality and it requires a depth of understanding and significant experience in GxP, quality, communication skills and business acumen to conduct responsibilities with little oversight. The Senior Associate of Supply Quality is responsible for providing support to ensure continuous supply of investigational medicinal products with GxP relevant international regulations (e.g., CFR part 210, 211, ICH6, EU, MHRA) and other global requirements. This position is based in our Framingham location and typically has a 5-day on-site expectation. Responsibilities Review packaging master batch records, packaging, labeling, for investigational medicinal product. Assist with conducting investigations ensuring effective root cause analysis and assigning of appropriate CAPAs. Maintain required knowledge of applicable regulations and government, industry, and company standards and their interpretations by participating in industry trainings, workshops, and discussion groups. Support of other QA projects as needed. Minimal Travel required - domestic and international. Represents Supply Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing Quality guidance. Supports the continuous improvement by updating policies and procedures as required. Collaborates cross functionally in support of Replimune's overall success. Qualifications Education: Bachelor's degree in science preferred. Required Experience: Minimum 5+ years of experience in GCP, GMP, and Quality Assurance/Compliance in the pharmaceutical, biopharma/biologics industry performing direct hands-on work in Quality Assurance, Quality Control, laboratories, manufacturing, supply chain, facilities, or engineering. A working knowledge of GxP practices, US FDA and EU GMP regulations and ICH guidelines. Demonstrated knowledge and direct experience with Quality Systems and GxP compliance within a regulated environment. Experience with Master Control, Veeva or eQMS systems preferred. Excel, PowerPoint, Word proficient Experience revising procedures and documents. Excellent attention to detail. Excellent verbal and written communication and presentation skills across all levels. Prioritize and manage multiple priorities and projects with little assistance. Familiarity with clinical supply areas and processes Minimal travel expected. 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 ****************** We are an Equal Opportunity Employer. #LI-onsite

The Director, Clinical Development/Clinical Scientist will report to the CMO or other senior member of the Clinical Development team to ensure the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners. The Director, Clinical Development will be accountable to jointly develop clinical program strategy and work collaboratively together with other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelines. The Director, Clinical Development will play a key role in the establishment and growth of Clinical Development functions to assure best-in-class global capabilities and execution. Specifically, the candidate will work closely with colleagues in clinical development, clinical operations, safety/pharmacovigilance, regulatory, biometrics, biomarkers and translational research, and program leadership. Responsibilities * Facilitate and execute the generation, author, update, and/or review of key clinical and regulatory documents, including, but not limited to: * Protocol concepts, synopses, protocols, and amendments * Informed consent documents * Investigator Brochures * Clinical study reports * Abstracts, posters and manuscripts * Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports * Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports * Risks / benefits analysis for applicable documents * Clinical study supporting documentations and processes, g. charters for (independent) safety data monitoring or steering committee, study specific management plans and manuals, SOPs, etc. * Instrumental to the Clinical Development Plan Generation and Program Strategy * Primary contact and lead for all clinical and scientific aspects of the design, implementation, conduct, analysis, interpretation and documentation of clinical Partner with relevant functional areas for the successful implementation and execution of clinical studies. Specific tasks will include but are not limited to the following: * Provide clinical and scientific expertise for selection of investigator and vendors * Train internal colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol * Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs * Review, query, and analyze clinical trial data * Serve as medical monitor or partner with (senior) medical director on medical monitoring, patient eligibility and study treatment related questions, in cooperation with the CRO or directly with study investigator * Interpret, and present clinical trial data, both internally and externally * Create clinical study or program-related slide decks for internal and external use * Represent a clinical study or development program on one or more teams or sub teams * Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings, engage advocacy groups * Contribute to or perform therapeutic area/indication research and competitor analysis * Build strong relationships with internal experts. * Identify continuous process improvement opportunities and help define/optimize standards and processes. * Identify incremental organizational resource needs - staff, budget, and systems. * Develop, track, execute and report on goals and objectives. * Support budget planning and management. * Be accountable for compliant business practices. Qualifications Educational requirements: * MD, PharmD, or PhD within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required. Experience and skill requirement: * Minimum of 10 years of experience and success within other biotech/pharmaceutical companies. * Previous participation in a clinical development program is essential, including involvement in most stages of clinical trials (i.e. from start up to study report), ideally having taken at least one study through from start to finish in a clinical scientist or similar role. * Clinical oncology experience; candidates with exceptional experience in other therapeutic areas would be considered if they demonstrated clear potential to apply their existing skills to oncology. * Expert understanding of global clinical study design and drug development process from discovery to registration and post-marketing. * High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills * Knowledge of GCP and ICH Guidelines * Flexibility to work with colleagues in a global setting * Able to engage in work-related travel approximately 25% * Demonstrated success in working in a cross-functional environment * Experience with the development and support of related SOPs and policies is expected. * Knowledge of industry standard Clinical Development IT solutions expected. * Executive presence. * Values based collaborator - respectful, accountable and collaborative. * Ability to relate and work with a wide range of people to achieve results. * Impactful written and verbal scientific communication. * Successful and superior influencing skills across all levels of the organization and external collaborators. * Problem solving and risk-mitigation skills. * Confident, positive attitude, enthusiastic and charismatic. * Appreciation of diversity and multiculturalism. * Strategic and creative thinker. * Ability to work independently and build working relations throughout the organization and with business partners to achieve business goals. * Strong time management and organizational skills. * Ability to manage multiple projects in a fast-paced environment. * Skilled in multiple computer-based tools, in addition to software programs such as Word, PowerPoint, Excel, etc. * must be able to travel as job requires which can vary (generally around 20+%)

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. The Senior Maintenance Technician will provide comprehensive maintenance, repair and service for facilities, utilities, systems and equipment (FUSE) at the Framingham cGMP manufacturing facility. Areas of responsibility include, but are not limited to, advanced installation, troubleshooting, maintenance, repair, testing, and documentation of maintenance activities. Experience working within FDA regulated environments (cGMP) and Environmental Health and Safety (EH&S) guidelines are required. Excellent interpersonal and communication skills (verbal and written) are required. This is a second shift position and requires a self-starter with the ability to work independently. The Senior Maintenance Technician must be able to provide a wide range of support for both utility systems and process equipment during production activities. Shift schedule is Monday through Thursday, work hours are 2pm-12:30am (4 day, 10 hour shift). This position is based in our Framingham location. Responsibilities Routine and complex preventive maintenance and repair on a variety of process equipment, building systems, central utilities and facility components and structures in compliance with cGMP policies and procedures. In-depth and detailed maintenance work including installing, operating, and maintaining utility systems and equipment that support facility operations. These include HVAC systems, building management systems, chillers, boilers, emergency generators, compressed air, process gas distribution, pure water, WFI and clean steam systems. Support the installation, startup and maintenance of cGMP manufacturing process and support equipment, including but not limited to incubators, bioreactors, filtration equipment, filling equipment, controlled-temperature storage equipment, etc. Oversee outside vendors and contractors to ensure work is performed and documented in compliance with cGMP policies and procedures. Ensure that all in-house and vendor work activities are performed following EH&S guidelines. Rotating on call responsibilities to provide emergency support on an as needed basis. Qualifications Educational and training requirements: Massachusetts Grade II Industrial Wastewater license (Required) Post-secondary degree in a technical field or a technical trade school degree preferred. One or more of the following preferred: Massachusetts Journeyman Electrician Massachusetts Journeyman Plumber Massachusetts Refrigeration Technician EPA Refrigerant Recovery Type I, II, III or Universal Certification Massachusetts Fireman 2 nd Class License Experience and skill requirement: Minimum of 3-5 years' experience in a maintenance technician or equivalent role Experience working within biotech, pharmaceutical environment or other regulated environment required. GMP preferred. Strong technical knowledge and practical experience in instrumentation, manufacturing equipment, building mechanical systems, emergency backup power equipment, including: Biological and chemical waste management. Lock out/tag out program. Ability to understand and comprehend utility and system drawings. Working knowledge of automation software, PLC controllers, electrical motors, variable speed drives, pneumatic and gas systems. Understanding of qualification and/or validation of facility equipment and utilities. cGMP documentation - Facilities documentation (work orders, equipment files, calibrations, developing SOPs) and QA systems (CAPAs, deviations, change controls) Working knowledge of Microsoft Office (Word, Excel, Outlook, etc.) Familiarity with Computerized Maintenance Management System (CMMS) to record maintenance work activities

Summary of job description: The Director, Pharmacovigilance Systems (PV Systems) will report to the VP, Global Drug Safety & Risk Management. The Director, Pharmacovigilance Systems manages the relationship and oversight of technology service providers, vendors, and business stakeholders. This position is also responsible for the delivery of systems, configuration and associated validation activities of Pharmacovigilance systems, and fulfillment of data change requests. The Director, Pharmacovigilance Systems will also participate in other department and cross-functional meetings with IT, Clinical, Regulatory, etc., as well as other intra and/or inter-departmental activities and initiatives. Responsibilities Responsibilities; Responsible for querying, retrieving, and organizing data as requested by various stakeholders from the safety database. Responsible for producing weekly, monthly, and ad hoc metric reports to support PV activities. Managing relationship with PV vendors regarding IT systems and services, including maintaining and updating system configurations in accordance with applicable procedures and regulations. Investigating, negotiating, managing, and implementing potential internal safety solutions for Replimune. Collaborate with internal stakeholders - including IT and business resources, contracts, and procurement - to develop criteria and best practices for vendor selection. Managing IT Budget for Global Drug Safety and Pharmacovigilance Systems. Evaluating, communicating, and mitigating potential risks. Participating in PV audits and inspections as an SME and providing reports as needed. Participating in PV vendor oversight activities such as vendor meetings. Other responsibilities: Other responsibilities as assigned Qualifications Qualifications: Bachelor's degree in the life sciences or related will be considered with applicable job experience. 10+ years of experience or the equivalent combination of education and experience. Experience and skill requirement: Experience in safety database applications (specifically, Argus Safety). Experience creating PV reports for aggregate reporting, reconciliation, and signal Well versed in data migration, application configurations, MedDRA and WHO Drug dictionary implementation. Proficient in authoring and reviewing of PV documents. Experience in vendor management, specific to safety systems. Experience in safety vendor selection and negotiation. Knowledge of PV regulatory reporting requirements. Ability to multi-task in a high-paced, fast-moving environment with changing priorities. Solid written and oral communication skills. Detail and solution-oriented, able to think outside the conventional “Big Pharma' mentality, and comfortable working in a small company/biotechnology environment. Able to work both independently and in a team environment. Proficient in standard computer software (Word, Excel, and Power Point). Physical Requirement: Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office environment. Knowledge of GCPs, GVP, ICH guidelines and FDA regulations and familiarity with EMA regulations and guidelines, and other international regulatory requirements.

We imagine a world where cancer is a curable disease. Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response. Replimune is pioneering the development of novel tumor-directed oncolytic immunotherapies. Our Talent Community is a great way to stay connected, learn more about Replimune and our career opportunities as well as to receive updates that may interest you! Thank you for joining!

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: We are seeking a motivated, detail-oriented Senior Associate to join the Supply Quality team. The successful candidate will assist with the implementation of GxP practices, Quality processes with specific emphasis on CMO labeling review, document control, and procedure revision and new procedure development. This role will require adaptability and eagerness to learn about all aspects of the Supply Quality processes to support relationships with internal stakeholders, contract manufacturing organization (CMO), suppliers, and clinical trial sites. The candidate will also interact cross-functionally with internal Quality Assurance, Quality Control, Clinical Operations, and Regulatory teams to ensure compliance to GxP processes and regulations. This position reports to the Director Supply Quality and it requires a depth of understanding and significant experience in GxP, quality, communication skills and business acumen to conduct responsibilities with little oversight. The Senior Associate of Supply Quality is responsible for providing support to ensure continuous supply of investigational medicinal products with GxP relevant international regulations (e.g., CFR part 210, 211, ICH6, EU, MHRA) and other global requirements. This position is based in our Framingham location and typically has a 5-day on-site expectation. Responsibilities Review packaging master batch records, packaging, labeling, for investigational medicinal product. Assist with conducting investigations ensuring effective root cause analysis and assigning of appropriate CAPAs. Maintain required knowledge of applicable regulations and government, industry, and company standards and their interpretations by participating in industry trainings, workshops, and discussion groups. Support of other QA projects as needed. Minimal Travel required - domestic and international. Represents Supply Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing Quality guidance. Supports the continuous improvement by updating policies and procedures as required. Collaborates cross functionally in support of Replimune's overall success. Qualifications Education: Bachelor's degree in science preferred. Required Experience: Minimum 5+ years of experience in GCP, GMP, and Quality Assurance/Compliance in the pharmaceutical, biopharma/biologics industry performing direct hands-on work in Quality Assurance, Quality Control, laboratories, manufacturing, supply chain, facilities, or engineering. A working knowledge of GxP practices, US FDA and EU GMP regulations and ICH guidelines. Demonstrated knowledge and direct experience with Quality Systems and GxP compliance within a regulated environment. Experience with Master Control, Veeva or eQMS systems preferred. Excel, PowerPoint, Word proficient Experience revising procedures and documents. Excellent attention to detail. Excellent verbal and written communication and presentation skills across all levels. Prioritize and manage multiple priorities and projects with little assistance. Familiarity with clinical supply areas and processes Minimal travel expected. 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 ****************** We are an Equal Opportunity Employer. #LI-onsite

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. The Senior Maintenance Technician will provide comprehensive maintenance, repair and service for facilities, utilities, systems and equipment (FUSE) at the Framingham cGMP manufacturing facility. Areas of responsibility include, but are not limited to, advanced installation, troubleshooting, maintenance, repair, testing, and documentation of maintenance activities. Experience working within FDA regulated environments (cGMP) and Environmental Health and Safety (EH&S) guidelines are required. Excellent interpersonal and communication skills (verbal and written) are required. This is a second shift position and requires a self-starter with the ability to work independently. The Senior Maintenance Technician must be able to provide a wide range of support for both utility systems and process equipment during production activities. Shift schedule is Monday through Thursday, work hours are 2pm-12:30am (4 day, 10 hour shift). This position is based in our Framingham location. Responsibilities * Routine and complex preventive maintenance and repair on a variety of process equipment, building systems, central utilities and facility components and structures in compliance with cGMP policies and procedures. * In-depth and detailed maintenance work including installing, operating, and maintaining utility systems and equipment that support facility operations. These include HVAC systems, building management systems, chillers, boilers, emergency generators, compressed air, process gas distribution, pure water, WFI and clean steam systems. * Support the installation, startup and maintenance of cGMP manufacturing process and support equipment, including but not limited to incubators, bioreactors, filtration equipment, filling equipment, controlled-temperature storage equipment, etc. * Oversee outside vendors and contractors to ensure work is performed and documented in compliance with cGMP policies and procedures. * Ensure that all in-house and vendor work activities are performed following EH&S guidelines. * Rotating on call responsibilities to provide emergency support on an as needed basis. Qualifications Educational and training requirements: * Massachusetts Grade II Industrial Wastewater license (Required) * Post-secondary degree in a technical field or a technical trade school degree preferred. * One or more of the following preferred: * Massachusetts Journeyman Electrician * Massachusetts Journeyman Plumber * Massachusetts Refrigeration Technician * EPA Refrigerant Recovery Type I, II, III or Universal Certification * Massachusetts Fireman 2nd Class License Experience and skill requirement: * Minimum of 3-5 years' experience in a maintenance technician or equivalent role * Experience working within biotech, pharmaceutical environment or other regulated environment required. GMP preferred. * Strong technical knowledge and practical experience in instrumentation, manufacturing equipment, building mechanical systems, emergency backup power equipment, including: * Biological and chemical waste management. * Lock out/tag out program. * Ability to understand and comprehend utility and system drawings. * Working knowledge of automation software, PLC controllers, electrical motors, variable speed drives, pneumatic and gas systems. * Understanding of qualification and/or validation of facility equipment and utilities. * cGMP documentation - Facilities documentation (work orders, equipment files, calibrations, developing SOPs) and QA systems (CAPAs, deviations, change controls) * Working knowledge of Microsoft Office (Word, Excel, Outlook, etc.) * Familiarity with Computerized Maintenance Management System (CMMS) to record maintenance work activities

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, caregivers and themselves. Join us, as we reshape the future. The Associate Director, Medical Writing, will provide writing assistance on various documents, including safety narratives, clinical study reports (CSRs), Development Safety Update Reports (DSURs), and other documents, as needed. This position will be responsible for coordinating the development of safety narratives (including drafting) and the compilation of the appendices for CSRs. The Associate Director, Medical Writing will coordinate the QC performed by external resources. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this position. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required. This position can be based either in our Woburn office (stronglyl preferred) or be a remote role * Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require. Responsibilities * Effectively partner cross-functionally in planning and preparation of high-quality clinical documents * Work effectively with company document management system and related tools, templates and procedures in order to ensure efficient production of documents. * Drives the process of development of clinical documents * Contribute to the development of documents, which may include but are not limited to clinical study protocols and amendments, IBs, CSRs, DSURs, and other documents, as needed * Summarize results presented in graphical, tabular, and/or listing format * Manage several MW projects simultaneously, including oversight of external writers, and maintain timelines for document completion * Coordinate document review and drive resolution meetings with cross-functional teams. * Review, edit, and ensure quality of documents in collaboration with internal functional area representatives or external contractors, as needed * Ensure document content and style complies with applicable regulatory requirements, SOPs, and company standards * Ensure consistency within and across documents as appropriate, including but not limited to review of text, tables, and figures for accuracy, logic, and clarity of presentation * Develop and/or update document templates, work instructions, style guides, and department-related processes (SOPs), and perform or support related training * Ensure a consistent style of presentation of documents to maintain quality and ease of review * May perform quality control (QC) reviews of clinical study documents as needed * Works with relevant teams to obtain accurate information and data for written materials * Provide teams a working knowledge of ICH guidelines and medical writing best practices * Represent Medical Writing on a cross functional team * Collaborate with and support the department leadership to ensure continuous improvement, and high standards for quality and productiveness. Qualifications Educational requirements: * Degree in science or medical related field * Master's degree or higher preferred Experience and skill requirement: * Must thrive working in a fast-paced, innovative environment while remaining flexible proactive, resourceful and efficient. * Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills. * Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system * Ability to work both independently and collaboratively with a team in a geographically dispersed environment * Demonstrated problem-solving ability, sense of urgency, and ability to prioritize tasks, to work simultaneously on multiple projects, and to independently complete high-quality documents according to timelines * Experience in successfully resolving conflicting editorial opinions expressed by team members * Strong team player that has a customer service approach and is solution oriented * Attention to detail and the ability to work individually, within a multidisciplinary team, as well as with vendors * Possesses strong written and verbal communication skills Background, Knowledge, And Experience * Has a minimum of 5 years of medical writing experience (minimum of 1 year of experience for individuals with a PhD, PharmD, MD, or equivalent) * Has a strong understanding of the fundamentals of clinical document development and documentation formatting within the industry * Working knowledge of ICH and medical writing best practices is required * Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology * Understanding of the fundamentals of clinical development and regulatory affairs (e.g. from working in a similar or an adjacent group in industry) * Proven ability of critical thinking, problem solving, and leading cross-functional teams * Experience in oncology strongly preferred *