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

The Quality Assurance (QA) Operation Specialist is responsible to provide QA support on operational areas involved in DNA Script Manufacturing activities. The QA Specialist reports to the Quality and Regulatory Group Leader.

Responsibilities

• Review and approve documentation (SOP, Work Instruction, Test Protocol, …)
• Review and approve Batch Manufacturing Records, Instrument Qualification report and other Quality-related records
• Recognizes ISO requirements and ensure compliance of Manufacturing and QC laboratories activities
• Conduct Quality walkthroughs in the laboratories
• Lead Quality Operational events (Nonconformance, CAPA, Change Control, …)
• Be the point of contact for team concerning quality-related topics, represent QA in meetings
• Work closely with various departments (including Product Development) to ensure new documentation or processes comply with Quality requirements
• Perform other duties as assigned

Qualifications and experience

Essential

• Bachelor's degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline (Biomedical Engineering, or other related engineering field) or related field, or equivalent combination of education and work-related experience
• Minimum 3 years of Quality Assurance experience
• Familiarity with ISO 9001, ISO 13485, 21CFR820, or biotech manufacturing and a thorough knowledge and understanding of cGMP
• Experience in the biotech/pharma industry
• Demonstrated leadership and strong organizational skills
• Attention to detail and problem solving
• Excellent written and verbal communication skills

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