Full-Time Scientist / Sr. Scientist, Cellular Process Development
Title: Scientist / Sr. Scientist, Cellular Process Development
Location: Waltham, MA
Reports to: Associate Director of Process Development
AlloVir is a publicly held, high-growth biotechnology company pioneering science in the field of virus-specific T cell (VST) therapies.
We embrace a shared mission to prevent and defeat life-threatening viral disease, champion truth, and challenge the status quo in pursuit of constant improvement.
Our innovative spirit lives beyond the lab, in a world where patients fighting viral infection have access to revolutionary allogeneic cell therapies. A world where everyone has access to a healthy immune system.
Success in this role means partnering across the organization to establish an innovative cell therapy manufacturing supply chain, taking a pro-active approach to identifying and overcoming risks and barriers, and challenging in the pursuit of continuous improvement.
At AlloVir, the expectation is that regardless of title, people are both group leaders and individual contributors. Much like medicine, we believe that this person can both do the work and set the work, working across functions seamlessly, sometimes in the lead position sometimes in support.
This position will provide key technical expertise to support the process development and process characterization studies for AlloVir’s viral specific T-cell pipeline which includes both early and late-stage therapies. This individual will engage both internal and external partners to define process requirements, develop and characterization of the processes. This position requires a hands-on individual with an understanding of Quality by Design (QbD) and process modeling, and a track record of achievement in the development and characterization of manufacturing processes for large molecule biologics, cell and/or gene therapy programs.
- Drive the design, execution, and analysis of process development studies to develop a thorough understanding of operational parameters and performance attributes, along with the impact to critical quality attributes (CQAs).
- Perform multivariate DOE studies for identification of critical process parameters and parameter range finding. Compile, organize, and analyze data across multiple experiments to enable process understanding and logical, data-driven decisions.
- Author technical documents (SOPSs, protocols, reports, risk assessments, specifications, CQAs), including drafting, reviewing, approval.
- Support CMC regulatory submissions (IND, BLA, etc) via authorship, review, approval of relevant CTD sections.
- Support technology transfer to external manufacturing partners and provide support in process scale-up.
- Provide laboratory support for manufacturing deviation investigations and evaluation of raw material and consumables changes.
- Bachelor’s degree or Master’s degree in Life Sciences or Engineering and 5+ years of relevant work experience. PhD preferred with 2+ years of relevant work experience.
- Demonstrated expertise in cell culture development of gene and / or cell therapies.
- Experience with closed system processing methods for cell therapies, blood and cell processing technologies, and cell characterization methods is highly desired.
- Possess skills in experimental design (e.g. DOE) and data analysis; experience with applying quality risk management tools to parameter selection and criticality classification.
- Experience with applying Quality by Design (QbD) principles to process characterization and the product development lifecycle.
- Experience authoring scientific publications and CMC regulatory submissions.
- Ability to translate complex scientific concepts into study design and data into reports and presentations is required.
Why join AlloVir?
AlloVir is the global leader in developing novel cell therapies that restore natural immunity against life-threatening viral diseases for immunocompromised patients.
We have an innovative pipeline of allogeneic, off-the-shelf, T-cell therapies that treat and prevent many devastating and life-threatening viral diseases. Our technology and manufacturing process enables the potential for the treatment and/or prevention of up to six devastating viruses with each single allogeneic cell therapy.
As part of the ElevateBio portfolio of companies, you’ll have access to award-winning facilities with centralized cell and gene therapy manufacturing capabilities that help advance the development of our revolutionary therapies for immunocompromised patients.
Join a team committed to scientific excellence, focused on passionate engagement, and united in purpose to treat and defeat viral diseases.
At AlloVir, we are committed to fostering and expanding diversity in the workplace. We strive to create an environment where everyone feels a sense of belonging and differences are celebrated as strengths. With a company vision of “ImmUnity for all”, we place special emphasis on unity, on equality, and on inclusion for all employees, patients, and partners.
AlloVir is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. AlloVir will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
How to ApplyPlease apply on our career page: https://www.allovir.com/careers
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