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Head of QA/QC: Ginkgo Bioworks – Boston, MA

Our mission is to make biology easier to engineer. Ginkgo is constructing, editing, and redesigning the living world in order to answer the globe’s growing challenges in health, energy, food, materials, and more. Our bioengineers make use of an in-house automated foundry for designing and building new organisms. Today, our foundry is developing over 40 different organisms to make different products across multiple industries.

To realize our dream of building a next-generation organism company, each of our organisms needs to be successfully deployed. And ensuring that the deployed product reproducibly meets specification is critical to Ginkgo’s success. We are seeking a Head of Quality Assurance/Quality Control to ensure Ginkgo, our customers, and our contract manufacturers have the necessary methods in place to guarantee we consistently meet the defined specifications.

The ideal candidate is a critical thinker who prioritizes quality assurance, and is able to interface with and incorporate information from multiple disciplines, both within Ginkgo and externally.

Responsibilities:

  • Manage a team of QA/QC Engineers in development and execution of analytical methods across a variety of projects
  • Provide technical expertise to a wide range of projects, including identification of new instruments for product analysis as needed
  • Incorporate interdisciplinary knowledge, specifically fermentation and process engineering, to ensure high quality method development
  • Liaise with project leads to ensure access to accurate & precise analytical methods for validation of process performance at key project stages during lab-scale development
  • Manage incoming and outgoing technology transfer of analytical methods to and from customers and CMOs, ensuring analytical alignment across sites
  • Develop and maintain documentation, and document change management, for all released assays
  • Work with internal and external regulatory teams to ensure regulatory requirements are captured in product specifications
  • Manage and execute stability testing of final product
  • Develop and issue certificates of analyses for final products, as needed
  • Travel up to 20% to customer and contract manufacturing sites

Desired Experience and Capabilities:

  • BS in chemistry, chemical engineering, or similar field with 10 years of industrial biotech experience, MS with 8 years of experience, or PhD with 5 years of experience
  • Strong background in analytical chemistry (process chemistry a plus)
  • Expertise in a wide range of analytical instruments including: HPLC, LCMS, GC-FID, GCMS, UV/Vis, FTIR, NMR
  • Knowledge of technical and quality requirements for the manufacturing of fermentation-derived materials across industries including food products, pharmaceuticals, polymers, flavors, and fragrances
  • Extensive management experience in the field of quality control and assurance
  • Familiarity with GMP, HACCP, and/or FDA regulations a plus

We also feel it’s important to point out the obvious here – there’s a serious lack of diversity in our industry and it needs to change. Our goal is to help drive that change. Ginkgo is deeply committed to diversity, equality, and inclusion in all of its practices, especially when it comes to growing our team. We hope to continue to build a company whose culture promotes inclusion and embraces how rewarding it is to work with engineers from all walks of life. Making biology easier to engineer is a tough nut to crack – we can’t afford to leave any talent untapped.

It is the policy of Ginkgo Bioworks to provide equal employment opportunities to all employees and employment applicants.

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Lio Tariman

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