DNA Script

DNA Script is a leading company in manufacturing de novo synthetic nucleic acids using enzymatic DNA synthesis (EDS) technology. The company aims at accelerating innovation in life science and technology through the decentralization of rapid, on demand and high-quality DNA synthesis. DNA Script's approach leverages nature's billions of years of evolution in synthesizing DNA to set a new standard for customizing nucleic acid synthesis thus accelerating discovery in genetics, genomics, and synthetic biology. Discovery disciplines with profound impacts upon humanity such as biopharma, translational genetics and even molecular information storage all start with synthetic DNA. The company has recently initiated the commercialization of its first EDS powered platform, the SYNTAX system.

To date, DNA Script has raised over $315M of financing, with leading investors such as Coatue Management, Fidelity Management and Research, Catalio Capital Management, Casdin Capital, LSP, Bpifrance Large Ventures, Danaher, Illumina Ventures, Agilent, Merck Ventures, Sofinnova Partners, Kurma Partners, T Rowe Price, Baillie Gifford and Eurazeo.

DNA Script also partners on technology and product development with leading organizations such as DARPA, IARPA, Moderna Therapeutics, GE Research, Illumina, the Broad Institute, Harvard University, Institut Pasteur and the French Department of Defense.

DNA Script has its research and manufacturing facilities headquartered in Paris, France, and is in the process of expanding its commercial and development teams in South San Francisco.

Opportunity and Challenges :

We are looking to assemble a team of best-in-class, innovative and passionately eager people. We want to gather their talents and skills to achieve one goal: unlock the power of “DNA-write.” We offer the opportunity of joining a dynamic, international, and highly skilled team in a pioneering startup. Our DNA On Demand platform not only has the potential to change the way the world makes and uses synthetic DNA, but also to accelerate the rate of discovery by delivering upon the promise of same-day results.

This is an opportunity to join a rapidly growing company and to have a large impact on developing a technology that will have far-reaching impacts across biological sciences.

The role

We are seeking a Senior Manager, Regulatory Affairs & Risk Management to provide support in developing and maintaining a strong regulatory & risk management culture at DNA Script (CE marked RUO products).

The Senior Manager, Regulatory Affairs & Risk Management will be responsible for leading and implementing a Regulatory Affairs strategy as well as developing and maintaining the Risk Management culture at DNA Script. Main activities also include the QR representation in new products development projects and project management.

The Senior Manager, Regulatory Affairs & Risk Management reports to the Quality & Regulatory Head.

Responsibilities

• Build, execute, and support a comprehensive long-term regulatory compliance strategy to meet global market requirements
• Ensure compliance to all current and future applicable regulations (REACH, RoHS, IEC 62304, EMC and Machinery Directives, ...) and manage Technical File
• Manage regulatory and risk management activities for assigned projects (mainly new products development), including QR representation on the core/project development teams

• Development of a Risk Management culture at DNA Script, establish and maintain product risk analyses
• Project management on structuring projects for the QR department (e.g. ISO 13485 certification project)
• Provide interpretation, leadership, guidance, and recommendations in assessing and resolving regulatory issues to ensure product quality and compliance
• Help on planning, architecting, implementation and continuous improvement of the Quality Management System

Essential

• Master or PhD in Chemistry, Biochemistry, Molecular Biology or related scientific discipline (Biomedical Engineering, or other related engineering field) or related field
• 8+ years of biopharmaceutical experience in quality & regulatory affairs and 4+ years in the regulatory affairs function in a biopharmaceutical company
• Deep knowledge of ISO 9001/13485, 21CFR820, or biotech manufacturing and a thorough knowledge and understanding of cGMP as well as REACH, RoHS, WEE, IEC 62304, EMC and Machinery Directives, ...
• Ability and interest in rolling up their sleeves to perform hands-on regulatory activities
• Independently motivated, excel at driving execution, detail oriented,
• Demonstrated leadership and excellent organizational skills to multi-task in a fast-paced environment
• Excellent written and verbal communication skills

Desirable

• Experience managing Regulatory Affairs for RUO products
• Experience as the lead of Risk Management
• Experience in project management, leading, mentoring, training, and working collaboratively with software and hardware development teams.

Miscellaneous

• Job located in South San Francisco, California
• Start date: As soon as possible.

Benefits:

• Health, Dental, Vision. Company pays 80% of premiums for employees and dependents. We have lots of plans available including HMOs, PPOs, HDHPs, etc.
• Life insurance
• 401(k) with 4% match
• Short and long-term disability insurance
• Other employee-funded plans including pre-tax commuter, HSA, and FSA
• EAP

Recruitment Process:

• Initial screening with the hiring manager
• Day interview at the office (or remote) with the manager, cofounders, HR and the rest of the team
• Reference Checks
• Timing: 2-3 weeks