Research Associate

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Research Associate

We are searching an experienced Core Analytics Research Associate who will assist in establishing a procedure driven, cross-functional analytical core facility at AVROBIO. The candidate will support analytical testing and develop new and novel methods to characterize and test AVROBIO stem cell products. The candidate will also qualify new and established test methods that assess the critical quality attributes of the product to support process development and analytical development activities. The Research Associate in 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.

Cambridge
Manufacturing
Oct 1 2021
Key Responsibilities
  • Establish internal core analytical capabilities to provide testing support for process development activities.
  • Establish and conduct experiments in the laboratory to support performance-based evaluations of analytical methods for stem cell products while providing support for additional process development activities.
  • Work with process development to identify critical assays to support ongoing process improvements and provide procedure driven, qualified assay support for process development campaigns.
  • Assist in the development of characterization assays for stem cell products in order to gain deep product understanding.
  • Responsibilities include product characterization using a variety of molecular biology-based (PCR, immuno assays), and cell-based assays.
  • Analytical testing responsibilities will include the establishment of physical, chromatographic, and electrophoretic based purity assays as well as ELISA based impurity assays.
  • Assist in the review and approval of phase-appropriate method qualification protocols and summary reports.
  • Assist in the generation, review, and reporting of analytical testing data using an Electronic Laboratory Notebook
  • Support the transfer and implementation and eventual qualification of Drug Product release assays in house and write related SOPs.
  • Run assays, document results, keep the lab inventory up to date, maintain equipment calibrated and the laboratory organized.
Minimum Requirements/ Qualifications
  • Bachelor’s degree and 2+ years of industry related experience.
  • An in-depth understanding of analytical development for biologics or more specifically gene therapy assays for autologous cell products.
  • Good documentation review skills, good writing skills, and the flexibility to move between the management and execution of each required function is needed
  • General knowledge of process development and scale-up for biologics
  • Technical understanding and/or experience with general lab techniques such as pipetting, making reagents, flow cytometer and cell culture techniques.
  • Experience in Process Development and/or Cell Processing methodologies is a plus
  • This hands-on position will require conducting laboratory experiments.
  • Comfortable with Microsoft Suite (particularly Excel, Powerpoint, Word) to analyze and record scientific data and results to prepare reports.
  • Independently motivated, with a good problem-solving ability
  • Very well organized, detail-oriented, and able to multitask in a very fast-paced environment
  • Demonstrate strong organizational and interpersonal skills
About AVROBIO

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