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The core analytics lab will work in coordination with the Cellular Process Development team to generate analytical data from samples collected during the process optimization and process characterization experiments. Responsible for the transfer and successful implementation of all Drug Product release and characterization assays in house. He/ She will be knowledgeable in assay qualification, sample management to ensure high throughput testing and good documentation practices to ensure data integrity in late phase Process Development. This...
The focus of this position is to provide leadership and laboratory support as a senior lab member of the Cellular Process Development team at AVROBIO, Inc. Responsible for setting up laboratory capabilities for Cell Process Development including CD34+ cell banking and Drug Product manufacturing in house using an automated Prodigy system. The Scientist will be responsible for evaluating and optimizing process steps as needed to improve process robustness. In addition, he/she will develop and qualify...
The Director, Drug Safety/Pharmacovigilance Operations will be responsible for the implementation, execution, and management of Pharmacovigilance and risk management activities in conjunction with the AVROBIO’s development and future looking commercial activities. The individual must effectively collaborate cross-functionally at all levels in the organization as well as external safety service providers in partnership with regulatory authorities. The Director, Drug Safety /PV Operations will lead and is accountable for providing oversight for pharmacovigilance functions which includes but...
The Director of Cell and Gene Therapy CMC Technical Writing plays a critical role in the development of our technical writing capabilities. In partnership with functional areas leads and regulatory leads, the Director is responsible for authoring the CMC sections of the AVROBIO’s global regulatory submissions from INDs, briefing books, license applications to post approval submissions. Core responsibilities include CMC technical writing, CMC source document and technical report writing, authorship of CMC sections of regulatory...
The Sr. Clinical Project Manager is the leader of the Clinical Study Team and will lead the planning and delivery of AVROBIO study(ies) to time, budget, and quality according to the Clinical Development Plan (CDP), Good Clinical Practice (GCP), local regulations, guidelines, and SOPs.
We are looking for a Pharmacometrician/Quantitative Pharmacologist who is passionate about their profession and inspired by being part of a team, working in life sciences, to bring Lentiviral Gene Therapy to patients. As a Pharmacometrician/Quantitative Pharmacologist for Lentiviral Gene Therapy, you will support the development of these novel therapeutic modalities from early phase to late phase and regulatory submissions. This individual demonstrates significant knowledge of pharmacometrics/quantitative pharmacology and will be responsible to apply novel translational...
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