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 a scale down model that reproduces the processing operations at a smaller scale, to evaluate process performance and implement a process control strategy in preparation for commercial manufacturing for a lead program. He/ she will design, conduct, and interpret process characterization experiments using statistical methods.

Cambridge

Manufacturing

Mar 1 2021

Key Responsibilities

Support the design, set up and organization of new process development laboratory at AVROBIO, Inc.
Establish process development capabilities including CD34+ cell banking and Drug Product manufacturing using an automated Prodigy system
Responsible for driving the late-stage strategy in the laboratory for a lead program
Design, conduct, and interpret process development and process optimization experiments
Develop and qualify a scale down model that reproduces the automated cell processing operations
Design, conduct, and interpret process characterization experiments using sound statistical methods
Tech transfer the automated cell manufacturing process from the external facility to our new process development lab in house in collaboration with manufacturing ops
Support manufacturing investigations as needed
Author and review technical documentation including risk assessments, technical protocols and reports
Represent the team at meetings, as needed, and assist in the writing and review of CMC sections for regulatory submissions.

Minimum Requirements/ Qualifications

PhD and 2+ years of industry experience, Master’s degree, and 5+ years of directly related experience, or bachelor’s degree and 7+ years of directly related experience
Strong background and in-depth understanding of culture techniques and cell processing technologies is a must
General knowledge of stem cell biology, analytical techniques, process scale-up and scale down concepts is preferred
Experience with Quality by Design (QbD) and Design of Experiments (DoE) approaches to Process Characterization and in depth understanding of statistical data analysis/software such as JMP is required
Direct experience working on late-stage process development, process characterization experimental campaigns, authoring Risk Assessments and Process Justification reports is preferred
This hands-on position will require conducting laboratory experiments and the flexibility to move between the project management and lab execution as needed
Strong organizational skills with the ability to embrace change and multi-task in a fast-paced environment
Excellent communication, technical writing, and presentation skills
Independently motivated, detailed oriented and a good problem-solving ability
Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and incorporation of multiple points of view
Track record of completing deliverables within specified timelines
Preference is given to candidates with late-stage process development and commercialization experience (PPQ, PAI, BLA, MAA)
Prior experience with Cellular Therapy or Gene Therapy pharmaceutical product development is highly desirable

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About AVROBIO

AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

AVROBIO, Inc is an EEO employer