Senior Production Engineer I - Boston, MA, United States - Ginkgo Bioworks

Description

Senior Downstream Production Engineer, AAV Bioprocessing and Development (DSP)

Ginkgo is looking for a highly motivated Senior Downstream Production Engineer, Cell and Gene Therapy to join the Foundry's expanding High-throughput Screening (HTS) team.

In this role, you will play a critical role to help establish, plan, develop and execute bioprocessing of AAV viral vectors.

The incumbent will be responsible for various aspects of development and production of recombinant Adeno Associated Virus (rAAV), streamlining the AAV production workflows, and defining the process improvements in alignment with the operational vision of Ginkgo Vector Core.

By adding your own expertise to an interdisciplinary team of bench scientists, computational biologists, data scientists, and software engineers, your role will be critical to developing world-changing methods for engineering biology.

This role is primarily located in Cambridge, however travel to our Boston office or other locations such as CDMO partners, workshops, offsite meetings etc., Provide technical leadership in the establishment of Downstream Production (DSP) cell and gene therapy within Ginkgo Bioworks.

Oversee early screening of AAV therapeutic candidates using quality by design and a DOE approach with purification unit operations.

Manage resources and oversee project planning across multiple teams and programs such as process development, vector engineering, and analytical development.

Provide technical/strategic guidance on viral vector development and manufacturing to insure project success.

Drive expansion of internal and external capabilities as needed which may include scoping, procurement and commissioning of CAPEX unit operations, both DSP and analytical in nature.

Coordinate efforts across interdisciplinary teams within Ginkgo's Foundry and 3rd party vendors.

PhD in Pharmaceutics, Biotechnology, Biomedical Engineering, Chemical Engineering, Biology or related field with a strong background in gene therapy-based drug product development and 3+ years industry experience.

Demonstrated experience with AAV purification techniques such as depth and sterile filtration, tangential flow filtration (TFF), AKTA column chromatography and CsCl, as well as lead formulation screening and stability testing in support of animal and TOX studies.

Track record of successfully leading the planning of large experiments using DOE and QBD approaches. Trending, interpretation and presenting of data to justify results and next steps required.

Experience with upstream techniques such as vial thaw, seed train expansion, cell culture, transfection and harvest helpful but not required.

Project management and/or management of CDMO and CRO partners is a plus.
Our mission is to make biology easier to engineer.

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