QA/QC Engineer

Boston, MA /
Deployment /
Full-time
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, we must ensure that quality is maintained during all stages of our projects, through to the successful deployment of our organisms and processes. Therefore, we’re seeking a QA/QC Engineer with chemical laboratory experience to help define product specification and maintain a Quality Management System.  Plus, you’ll ensure that Ginkgo, our customers, and our contract manufacturers have the necessary methods and processes in place, so that we maintain compliance across any required regulatory standard and consistently meet the defined product and process specifications.

Responsibilities

    • Develop, validate, and execute analytical methods, focusing primarily on accurate and precise quantitation
    • Perform QA/QC data collection, data integration, and data archiving, with the use of Ginkgo’s proprietary LIMS (laboratory information management system)
    • Lead incoming and outgoing tech transfers, including validation, interacting with customers and CMOs, and SOP generation 
    • Monitor, analyze, and characterize in-process and finished product samples
    • Support the analysis of pilot and commercial scale fermentation and downstream processing, as well as the validation of process performance at key project stages during lab-scale development
    • Maintain analytical instruments and associated maintenance logs, troubleshooting instrument malfunctions as needed
    • Design and execute stability studies, provide stability assessments, and inform specification changes and investigations as appropriate
    • Support quality compliance in Ginkgo’s Clinical Laboratory, including developing SOPs and other guidance documents for quality assurance, and assisting senior QA members in document control and review, as needed

Desired Experience and Capabilities

    • BS in chemistry, chemical engineering, or related field with 1-6 years of industrial experience; OR Ph.D.
    • Hands-on experience in or working knowledge of analytical testing using GC, GCMS, HPLC, LCMS, FTIR, UV-Vis, and/or NMR
    • Ability to work well within a team in a fast-paced environment, and balance multiple projects simultaneously
    • Excellent communication, problem solving, and data analysis skills
    • Knowledge of technical and quality requirements in the manufacturing of biotech products, including familiarity with GMP, HACCP, or CLIA requirements a plus
    • Experience performing QC review (document verification and audit trail review) a plus


To learn more about Ginkgo, check out some recent press:
Ginkgo Bioworks Awarded $40MM NIH RADx-ATP Contract to Expand High Throughput SARS-CoV-2 Testing (PR Newswire)
Ginkgo Bioworks CEO on scaling up Covid-19 testing: ‘If we try, we can win’ (CNBC)
Ginkgo raises $70 million to ramp up COVID-19 testing for employers, universities (Boston Globe)
Ginkgo Bioworks Redirects Its Biotech Platform to Coronavirus (Wall Street Journal)
Ginkgo Bioworks Provides Support on Process Optimization to Moderna for COVID-19 Response (PRNewswire)
The Life Factory: Synthetic Organisms From This $1.4 Billion Startup Will Revolutionize Manufacturing (Forbes)
Synthetic Bio Pioneer Ginkgo Raises $290 Million in New Funding (Bloomberg)
Ginkgo Bioworks raises $350 million fund for biotech spinouts (Reuters)
Can This Company Convince You to Love GMOs? (The Atlantic)

We also feel that it’s important to point out the obvious here – there’s a serious lack of diversity in our industry, and that 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. Our culture promotes inclusion and embraces how rewarding it is to work with people from all walks of life.  

We’re developing a powerful biological engineering platform, we must remain mindful of the many ways our technology can – and will – impact people around the world. We care about how our platform is used, and having a diverse team to build it gives us the best chance that it’s something we’ll be proud of as it continues to grow. Therefore, it’s critical that we incorporate the diverse voices and visions of all those who play a role in the future of biology.

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