Replimune is a fast-paced growing innovative company that is in the process of bringing on-line a brand-new production facility purposefully designed to manufacture our Oncolytic Immunotherapies. This multi-product facility in Framingham contains cGMP manufacturing for both drug substance and drug product, as well as process development laboratory space. Working in collaboration with colleagues within Analytical […]
The Associate Director – Clinical Development will support Replimune 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 successful candidate will report to the Senior Director or CMO, Clinical Development.
The Associate Director, Clinical Operations (AD, Clin Ops) is responsible for the planning, implementation and conduct of large, global, complex clinical trials in Phase I-IV; or multiple smaller early-phase studies. The AD, Clin Ops manages the clinical project team to ensure adherence to overall project timelines and budget.
The Associate Director, MSPV Safety Scientist will be accountable for assigned Replimune product(s) and for the overall safety profile of the products. This position will be responsible for safety surveillance, risk management, and risk communication for all products in clinical development. This position will lead medical safety assessment of individual case safety reports and, aggregate safety data, and authoring and/or review of major safety deliverables.
Reporting into the Senior Director, Quality Assurance, the Associate Director of Quality Systems supports the development and implementation of Replimune quality systems to ensure compliance with US and international regulations, laws and guidelines including ICH Q10. The Associate Director of Quality Systems will have the opportunity to create influential and collaborative relationships for Quality Assurance across the company and will be accountable for but not limited to; training, documentation, and quality metrics.
Replimune is committed to developing and commercializing oncolytic immuno-gene therapies for patients devastated by a cancer diagnosis. Its platform is cutting edge and has the potential to revolutionize the cancer treatment paradigm. Founded in 2015, Replimune now has multiple products in clinical trials and a strong pipeline. Replimune is a well-capitalized publicly traded company (Nasdaq: […]
The Director – Clinical Development will support Replimune 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 successful candidate will report to the Senior Director or CMO, Clinical Development.
Working in collaboration with colleagues within process development, the Senior Associate will assist with performing lab-based process characterization and optimization experiments in support of commercialization. This individual will have an opportunity to work across all steps within the drug substance production process (upstream and downstream). In addition, there will be opportunities to participate within important projects within the drug product process as they arise.
Replimune is a fast-paced growing innovative company that is in the process of bringing on-line a new production facility purposefully designed to manufacture our Oncolytic Immunotherapies. This multi-product facility in Framingham contains cGMP manufacturing suites and Quality Control testing laboratories. The Quality Control (QC) Microbiology Analyst will be responsible for the performance of the routine […]
Reporting into the Manager, Clinical Quality Assurance, the Senior Associate, Clinical Quality Assurance will support and ensure that all systems and processes are compliant with good clinical practice (GCP) guidelines, standards, and regulations (FDA, MHRA, EMA, ICH).
This position provides cross-functional support of GXP activities as they relate to Quality Systems. This position will participate in the improvement of Quality Systems to ensure quality and adherence with current Good Manufacturing Practice (cGMP) and inspection readiness.
The Senior Manager, Clinical Outsourcing plays a critical role as part of Replimune’s Clinical Development team. Under the direction of the Director, Clinical Outsourcing, the Senior Manager develops and manages the operational and strategic processes which support the implementation and management of global clinical outsourcing.