Scientist / Sr. Scientist Assay Development (Biomarker, Safety, Potency, Vector)

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Senior Scientist / Scientist Analytical Development (Assay Development)

The Scientist / Sr. Scientist Assay Development is a scientific lead within the Centralized Analytical Development (CAD) function, playing a key role in assay development of potency, safety, and biomarker assays to support the full lifecycle of AVROBIO’s portfolio of lentiviral Cell & Gene Therapy programs. This role reports to the function head and works closely with AVROBIO’s Clinical, Manufacturing, and Preclinical R&D functions as well as with external contracted vendors.

Cambridge
Research and Development
May 23 2022
Key Responsibilities
  • Independently lead and perform the design, development, and transfer of biological assays in alignment with phase-appropriate risk-based strategies and project timelines
  • Represent the CAD team and serve as technical subject matter expert on cross-functional technical teams.
  • Provide mentorship and technical leadership of analytical procedures to train other scientists and build in-house analytical capability
  • Identify, develop, and document new technologies and methodologies to meet program needs
  • Manage the development and qualification of analytical test methods at outsourced Contract Research Organizations (CROs), in accordance with regulatory guidelines and standards, including management of associated deliverables, budget, contracts, and timelines
  • Author study plans, procedures, and reports
  • Perform statistical data analysis and data QC
  • Adhere to ALCOA+ principles for data integrity and documentation
Minimum Requirements/ Qualifications
  • B.S. or M.S. in Biology or related field with 7+ years of experience in assay development and qualification/validation within a biotech or pharmaceutical development context
  • Highly skilled in molecular, enzymatic, cellular, flow cytometry, and immuno assay development
  • Proven track record of high-impact contributions in assay and analytical development
  • Strong knowledge of industry regulatory guidance (FDA/EMA) for the validation of analytical methods
  • Ability to design and execute a study plan aligned with the activity scope, applicable regulatory guidelines, program timelines and priorities.
  • Proven ability to qualify or validate assays for CMC or clinical purposes is highly preferred
  • Prior experience with lentiviral therapy programs or lysosomal storage disorders is highly preferred
  • Ability to partner across a matrixed environment and work well in a team
  • Knowledge of GLP and/or GMP as relevant to laboratory practices in sample handling, analysis, and documentation is preferred
  • Adaptable to work on multiple projects
  • Excellent organizational, documentation, and communication skills; attention to detail, adaptive learning, critical thinking, and multi-tasking
  • Experience with regulatory submission preparation is desired
About AVROBIO

Our vision is to bring personalized gene therapy to the world. We aim to prevent, halt and/or reverse disease throughout the body with a single dose of gene therapy designed to drive durable expression of therapeutic protein, even in hard-to-reach tissues and organs including brain, muscle and bone. AVROBIO’s pipeline is powered by our industry-leading plato® gene therapy platform, our foundation designed to deliver gene therapy worldwide. It includes clinical programs in Cystinosis and Gaucher disease type 1, as well as preclinical programs in Gaucher disease type 3, Hunter syndrome and Pompe disease. We are headquartered in Cambridge, Mass.

AVROBIO, Inc is an EEO employer.