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Scientist I, Vector Process Development

ElevateBio

ElevateBio

Waltham, MA, USA
Posted on Tuesday, July 9, 2024

ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

The Role:

Elevatebio is looking for a Scientist for the process development of viral vectors (AAV, LVV, etc.). This position is responsible for the upstream process development and supporting GMP manufacturing activities for viral vectors and genetically modified products. The Vector Process Development group will lead the translation of research process to cGMP compliant manufacturing using state of the art technology. The vector process development upstream scientist will be responsible for the development, scale up and technology transfer of production processes for viral vector manufacturing processes with a focus on perfusion technology (ATF, TFDF, or TFF). The Scientist is required to have experience developing viral vector manufacturing processes. The successful candidate must have successfully demonstrated technical proficiency, scientific innovation, independent thinking and cross-functional collaboration.

Here's What You’ll Do:

  • Drive the development of a robust and highly productive upstream process for the manufacturing of viral vectors (primarily focused around LVV and AAV) with the use of perfusion technology (ATF/TFDF).
  • Design and conduct process development studies based on with the use of statistical models for range defining and process characterization activities
  • Support technology transfer and scale-up production internally and to CMO facilities with the use of process knowledge based on PD capabilities and scales
  • Generate and manage data reports in an ELN system and support the verification of further datasets to ensure accuracy and QA compliance
  • Represent the process development function in internal cross-functional team forums to provide insight and direction based on PD knowledge and support communication with external forums (i.e. conferences, webinars) with PD knowledge and capabilities
  • Author, review, and approve protocols and reports for process development studies within the Veeva quality system

Requirements:

  • Degree in a biology, engineering, or a related field with a preference of advanced degrees (MS or PhD): PhD with 1-2 year of relevant experience; or a MS with 4-5 years of industrial experience, or BS with 6+ years of industrial experience
  • Biotech experience is strongly preferred including experience working in a process development/ R&D/cGMP environment
  • Relevant experience working with biologics required; experience with viral vectors preferred
  • Prior experience with cell culture development, including work with media and related raw material attributes
  • Prior experience with stir tank and fixed bed bioreactors is required
  • Prior experience with perfusion systems within bioreactor unit operations, including ATF, TFF, or TFDF operational knowledge
  • Strong understanding of DoE and statistical analysis, with experience in JMP or Minitab software for design and analysis
  • Capable of leading multiple projects with effective communicating and technical writing skills to support client and internal timelines

Why Join ElevateBio?

ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.

We aim to be the dominant engine inside the world’s greatest scientific advancements harnessing human cells and genes to alter disease.

Our Mission:
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.

Our Vision:
We seek to be the world’s most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.

ElevateBio 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. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.