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 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 Facilities Engineer is responsible for GMP and non-GMP utilities and equipment engineering at the Framingham, MA manufacturing facility. The Facilities Engineer will provide routine engineering support for utilities, lab and manufacturing equipment, as well as project engineering and validation support. This position will include equipment ownership responsibilities for a select portion of equipment/utility portfolio serving as subject matter expert leading investigations relating to non-conformance events in partnership with Quality, Manufacturing and other departments.
The Head of Biometrics will be a member of the R&D leadership team and will be a significant contributor to the overall R&D strategy at Replimune, and reporting to the Chief Medical Officer. The Head of Biometrics will serve as a strategic partner with Clinical Development, Regulatory Affairs, Medical Affairs and Clinical Operations to provide drug development leadership on the design and execution of robust clinical development plans.
Partner cross functionally with clinical development and operations, regulatory affairs, medical affairs, biostatistics and translational research departments in planning and preparation of high quality clinical and regulatory documents. The writer will maintain working knowledge of Replimune strategic plans and provide writing and editorial assistance on various documents, including clinical study protocols and ICFs, Investigator brochures, regulatory documents, clinical study reports, patient safety narratives, biomarker-related documents, scientific abstracts and publications, healthcare provider and patient education materials and other written materials as requested.
Be part of a small dedicated team that is developing the manufacturing process and formulation of Oncolytic viruses for the treatment of cancer. Establish manufacturing methods and techniques for the generation and purification of live attenuated viruses. The scientist will be required to use their knowledge of biological processing theory, techniques and equipment to prepare and execute experimental protocols and to develop manufacturing processes.
The Scientist, Quality Control will perform QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). This role may also include the responsibility of overseeing the work of more junior QC staff. The QC Scientist will be responsible for assisting with the setting up and maintaining systems for QC Analytical Laboratory. The QC Scientist will be required to assist with scheduling, performing and reviewing of tests results of in-process, final drug product and stability samples following established test method (SOPs).
The Senior Assay Development Technician is responsible for taking a lead role in supporting the day-to-day operation of the Analytical Development laboratories. The Senior Assay Development Technician will also perform routine testing and provide support for method development projects.
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 Scientist, Quality Control will perform QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). The Senior Scientist, Quality Control will be responsible for assisting with the setting up and maintaining systems for QC Analytical Laboratory. The Senior Scientist, Quality Control will be required to assist with scheduling, performing and reviewing of tests results of in-process, final drug product and stability samples following established test method (SOPs).
The Sr. Director/Executive Director of Program Management ensures consistent processes and techniques are deployed to deliver programs on time, on budget and with appropriate quality. This role will have substantial focus on Clinical Program Management. Works cross-functionally and with external partners to enable the execution of Replimune’s strategic direction.
This multi-product facility in Framingham contains cGMP manufacturing suites and Quality Control testing laboratories. Working in collaboration with cross functional teams, the Senior Quality Control (QC) Analyst will assist in the setup of the QC laboratories and oversee the testing programs for raw materials used in the production process. The Senior Quality Control (QC) Analyst will be responsible for performing the routine and non-routine QC sampling and testing of raw materials following Standard Operating Procedures (SOPs) and established test methods.
The Validation Engineer is responsible for establishing and maintenance of validation plans and procedures for qualification of equipment at the Framingham, MA, manufacturing facility in accordance with appropriate regulatory guidance. The individual will work with customers and external contractors to coordinate scheduling, execution and review of qualification protocols / reports. The Validation Engineer will assist with setting up, qualifying & maintaining a monitoring system for GMP equipment. The individual will maintain the validated status of the facility and equipment through calibration, performance monitoring and requalification assessments.
Replimune’s mission is to discover and deliver a new generation of cancer treatments called oncolytic immunotherapies. Oncolytic viruses combine multiple mechanisms of action, enhancing the ability of viruses to replicate in and kill cancer cells, and generating a robust patient-specific, systemic anti-tumor immune response. Oncolytic immunotherapy is expected to strengthen the effectiveness of immune checkpoint […]