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

Job Description

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.

Special Notes

*Please note: This role is primarily located in Cambridge, however travel to our Boston office or other locations such as CDMO partners, workshops, offsite meetings etc., will be required.

Responsibilities

• 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.
• Support identification, screening and audit of CDMO while serving as point of contact and PIP as appropriate.
• Grow and mentor Ginkgo researchers working on Cell & Gene Therapy specific challenges.
• Assist with shaping Ginkgo’s overall direction as a company and support its evolving needs, as necessary.

Minimum Requirements

• 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. Or a BS/MS degree and 7+ years relevant 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.
• Experience with analytical techniques such as qPCR, hcDNA, HCP, SDS-Page, SEC, etc.
• 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.
• Ability to work in a cross functional, fast paced environment.

Preferred Capabilities and Experience

• Experience with upstream techniques such as vial thaw, seed train expansion, cell culture, transfection and harvest helpful but not required.
• Experience or understanding of HTS and high-throughput analytics desired but not required.
• Project management and/or management of CDMO and CRO partners is a plus.