Senior Research Associate, Assay Development (Biomarker, Safety, Potency, Vector)

Our culture is entrepreneurial, inclusive and caring. We're passionate about our work. And we embrace a pioneering spirit. Join us as we strive to develop innovative therapies with the power to give people with genetic diseases freedom for life.

Senior Research Associate, Assay Development (Biomarker, Safety, Potency, Vector)

The Senior Research Associate Assay Development is a valued member within the Centralized Analytical Development (CAD) function, playing a key role in development and performance of potency, safety, and biomarker assays to support the full lifecycle of AVROBIO’s portfolio of lentiviral Cell & Gene Therapy programs. This role works closely with AVROBIO’s Clinical, Manufacturing, and Preclinical R&D functions.

Research and Development
Jun 29 2022
Key Responsibilities
  • Work with team to design, development, troubleshoot, and transfer biological assays in alignment with phase-appropriate risk-based strategies and project timelines
  • Perform assay qualification in alignment with regulatory guidance
  • Perform feasibility and characterization assessments to assess novel or commercial reagents and materials
  • Analyze cellular, mouse, and/or human samples using established protocols
  • Provide scientific leadership and mentorship to expand in-house and outsourced capabilities
  • Develop and document new technologies and methodologies to meet program needs
  • Work as part of a cross-functional team to drive innovation and portfolio programs
  • 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., M.S., Ph.D in Biology or related field with 3+ years of experience in assay development and qualification/validation within a biotech or pharmaceutical development context
  • Experience in viral vector, molecular, enzymatic, cellular, flow cytometry, mass spec, and/or immuno assays highly preferred
  • Mammalian cell culture and transduction experience are a plus
  • Knowledge of industry regulatory guidances (FDA/EMA) for the validation of analytical methods is preferred
  • Prior experience with lentiviral therapy programs or lysosomal storage disorders is highly preferred
  • Able to work independently and to work well in a team
  • Adaptable to work on multiple projects and with evolving priorities
  • Excellent organizational, documentation, and communication skills; attention to detail, adaptive learning, critical thinking, and multi-tasking skills
  • Strong desire to make impactful contributions

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

AVROBIO, Inc is an EEO employer