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Associate General Counsel, Regulatory

American Indian Science and Engineering Society

This is a Full-time position in Boston, GA posted December 11, 2020.

n n nn nn Description nn Our mission is to make biology easier to engineer.

Ginkgo is constructing, editing, and redesigning the living world to answer the globe’s growing challenges in health, energy, food, materials, and more.

Our bioengineers make use of an in-house automated foundry to respond to these challenges by designing and building new organisms and sequencing the natural world.

Today, our foundry is deeply engaged in responding to the COVID-19 pandemic by developing sequencing-based diagnostics, partnering with other diagnostics developers to build our Concentric test offerings and collaborating with vaccine developers.

We are also developing organisms to make products across multiple industries.n nOur Corporate Legal Team is focused on providing creative solutions for the groundbreaking endeavors that Ginkgo drives forward.

We strive for agility, efficiency, and collaboration in our work, and enthusiastic irreverence in our team-building activities.

As Associate General Counsel, Regulatory, you’ll be the primary liaison with our strategy team to provide regulatory advice for Ginkgo’s diagnostics and government initiatives.

You’ll also help to support our diagnostics portfolio that includes internally developed and partnered laboratory developed tests for COVID-19, as well as externally developed lateral flow assay tests for COVID-19.

Reporting directly to our General Counsel, your role will be critical to the success of our growing organization.n n Please note: n n
– We are interested in applicants that have experience in both diagnostics and government procurement projects, but we will consider those with expertise in either area.

n n
– We are looking for applicants with 8+ years of experience as regulatory counsel, but will consider candidates with less those for a senior counsel role.

n n Responsibilities Serve as the primary liaison with Ginkgo’s strategy team to provide regulatory advice for our diagnostics and government initiatives.

Support Ginkgo’s diagnostics portfolio that includes internally developed and partnered laboratory developed tests for COVID-19, as well as externally developed lateral flow assay tests for COVID-19.

n n Desired Experience and Capabilities 8+ years of experience as regulatory counsel J.D.

degree and current bar membership in good standing Ability to communicate effectively with internal contributors at all levels within the organization to establish guardrails around strategy and implementation of corporate endeavors Law firm and in-house experience preferred In-depth knowledge of laws associated with domestic and international distribution of medical devices and delivery of services by a CLIA (or international equivalent) laboratory, including knowledge of anti-kickback laws, false claims act, EKRA, FDCA and license, and permit and import/export requirements for distribution of medical devices Experience working with government agencies on procurement and research agreements, with a working knowledge of FAR and DFAR rules and guidelines Negotiation and deal experience with distributors, suppliers, and service providers in an insurance-reimbursed industry Strong understanding of the laws governing data privacy, particularly with respect to HIPAA, GDPR, and state laws protecting patient privacy Adaptable to changing priorities and business strategies Responsive and communicative Engaging proactively with multiple teams and stakeholders within the organization to align operations with applicable legal requirements Humble approach to allocation and delegation of work and responsibilities Efficient management of projects and requests from internal clients from various functional groups Real-time risk management capabilities in a landscape with shifting regulations and guidance Enthusiasm for working in a fast-paced and dynamic environment n nTo learn more about Ginkgo, check out some recent press:n n Ginkgo Bioworks CEO on scaling up Covid-19 testing: ‘If we try, we can win’ (CNBC) n n Ginkgo raises $70 million to ramp up COVID-19 testing for employers, universities (Boston Globe) n n Ginkgo Bioworks Redirects Its Biotech Platform to Coronavirus (Wall Street Journal) n n Ginkgo Bioworks Provides Support on Process Optimization to Moderna for COVID-19 Response (PRNewswire) n n The Life Factory: Synthetic Organisms From This $1.4 Billion Startup Will Revolutionize Manufacturing (Forbes) n n Synthetic Bio Pioneer Ginkgo Raises $290 Million in New Funding (Bloomberg) n n Ginkgo Bioworks raises $350 million fund for biotech spinouts (Reuters) n n Can This Company Convince You to Love GMOs?

(The Atlantic) n nWe 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.

n nWe’re developing a powerful biological engineering platform, so 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.n nIt is the policy of Ginkgo Bioworks to provide equal employment opportunities to all employees and employment applicants.

n n nn nn Job Information nn Job ID: 55394719 Position Title: Associate General Counsel, Regulatory nnPlease refer to the company’s website or job descriptions to learn more about them.nn n n

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