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Associate Director, Core Analytics

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...

Mar 1 2021
Manufacturing
Cambridge

Scientist, Cellular Process Development

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...

Mar 1 2021
Manufacturing
Cambridge

Director, Drug Safety/Pharmacovigilance Operations

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...

Director, CMC Technical Writing

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...

Feb 8 2021
Manufacturing
Cambridge

Senior Manager, GMP Quality Operations

Responsible for quality oversight of external GMP Quality operations and support for clinical-stage lentiviral-based gene therapies, and the various activities in the disposition of clinical final product. This includes Review and approve non-conformance and CAPA issues, as well as approve and monitor the status of GMP related deliverables from external manufacturers. The individual will be responsible for supporting our internal team responsible for overseeing a network of global contract manufacturers and providing GMP Quality oversight...

Sr. Clinical Project Manager

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.

Feb 8 2021
Research and Development
Cambridge

Associate Director, Clinical Biomarker Lead

The Clinical Biomarker Lead will be responsible for implementing the clinical biomarker strategy and execution for assigned program(s) Clinical Trial(s) and implementing the biomarker plan during clinical development. The Clinical Biomarker Lead will collaborate with Research/Preclinical and Clinical Development on development of translational biomarker plans and inclusion of Clinical Biomarkers in clinical studies, including study design. The role will coordinate with Translational Data Sciences and Advanced Analytics to support quantitative pharmacological approaches during clinical development....

Jan 24 2021
Research and Development
Cambridge

Director, Clinical Quality & Compliance Lead

The Director, Clinical Quality & Compliance Lead will serve as the business and process strategic leader responsible for planning, optimizing, implementing, managing, and continuously improving the following within the Clinical organization: Standard Operating Procedures (SOPs), systems, processes, communication, and infrastructure (internal and external) in support of AVROBIO clinical programs. This role will partner with the Clinical functions, Quality Assurance, Supply Chain, and other departments within AVROBIO as well as investigational sites and clinical vendors.

Jan 24 2021
Research and Development
Cambridge

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