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Manufacturing Science Sr. Engineer (PIP)

Company: Planet Pharma
Location: Somerville
Posted on: May 3, 2021

Job Description:

Company OverviewRepertoire Immune Medicines is a clinical-stage biotechnology company working to unlock and direct the remarkable power of the human immune system to prevent or treat cancer, as well as autoimmune and infectious disease. The company is founded on the belief that the repertoire of T cell receptor (TCR)-antigen codes that drive health and disease represents one of the greatest opportunities for innovation in medical science. Repertoire scientists created and developed the DECODE and DEPLOY suite of technologies, which allow in-depth characterization of TCR-antigen pairs, and the ability to rationally design and develop novel targeted immune medicines.From its sites in Cambridge, Mass., and Zurich, Switzerland, Repertoire's team of more than 120 is creating a new category of immune medicines enabled from its DECODE discovery platform. The company's first product in the clinic is a novel multiclonal T cell therapy consisting of T cells derived from the peripheral blood, activated against a curated set of antigens, and armed with a proprietary cytokine. Repertoire is in clinical-stage immuno-oncology development today, targeting metastatic solid tumors. In the field of autoimmunity, Repertoire is using its proprietary platform to discover novel epitopes and TCRs from patients with type 1 diabetes. The company is also using its DECODE platform to discover infectious disease antigens and responding T cell clones.*PIP - Person in Plant - this person will be onsite at Patheon, Repertoire's CMO.Location:Princeton, NJ or Cambridge, MAThis person will spend 75% of time in Princeton, NJ at CMO, 25% in Cambridge. Role OverviewThe role provides technical oversight for manufacturing, identifies opportunities to improve process efficiencies, and mitigates cell therapy manufacturing process risks. This position will collaborate closely with the process and analytical development teams and be responsible for leading Repertoire's on site support at our cell therapy contract manufacturing organizations. The successful candidate will have experience in cell therapy process development and manufacturing, and be able to work highly independently in a fast-paced environment. Proven excellence in technical problem solving, project management, and communication is a must.Responsibilities:Provides technical and on-the-floor oversight at CMO sites during Tech Transfer and GMP manufacturing. Performs hands on training with manufacturing staff and serves as process subject matter expert (SME) during GMP manufacturingServes as Liaison to Process Development, Quality Control, Quality Assurance, Supply Chain and Clinical Operations, as needed.Utilizes manufacturing process knowledge and investigation skill sets to troubleshoot, identify and resolve manufacturing issues, improve process operations and affect positive change.Manages all aspects of process transfer ensuring that project objectives and timelines are achieved, and work is thorough and well-coordinated.Regularly provides progress reports and other status updates to the Technical Operations leadership teamPractices and promotes safe work habits and adheres to Repertoire's safety procedures and guidelines.Up to 75% domestic travel to Domestic Contract Manufacturing Sites.Qualifications:Advanced degree (MS/PhD) in Chemical/Biochemical Engineering, Biochemistry or related degree with experience in process development, manufacturing sciences in cell or gene therapy, biotechnology or pharmaceutical industry.5+ years Industry experience with process technical transfer, risk assessments, technical operations, and quality systems interfacing a GMP environment. Experience with aseptic processing, cell culture, cell or gene therapy manufacturing and cell isolation Working knowledge of analytical testing, such as flow cytometry and cell counting analytics is preferredKnowledge of Immunology or Immune-oncology, especially T cell biology is desiredExcellent communication and interpersonal skillsHighly organized with immense attention to detailDemonstrated effective collaboration and communication with laboratory and manufacturing staffSDL2017

Keywords: Planet Pharma, Somerville , Manufacturing Science Sr. Engineer (PIP), Other , Somerville, Massachusetts

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