Director, Reagents & Kits Development

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 Mission:

The candidate selected for this role will lead a new department within DNA Script’s Product Development organization responsible for all aspects of reagent, kit and consumable development from technology transfer from the R&D organization through to design transfer to Operations.

Responsibilities:

• Provide strategic leadership and technical direction in defining and achieving reagent, consumable, and kit development objectives

• Ensure that plans are in place and execute accordingly to clearly establish performance specifications of incoming and outgoing material, establish analytical and functional tests required for qualifying raw material and finished goods

• Drive reagent development and improvements to include buffer formulations, enzyme clone optimization, and nucleotide and other raw material refinement

• Create and implement processes for formulation optimization, guardbanding, and stability improvements including initial characterization, verification and validation for each element

• Translate feasibility-ready formulation instructions into scaled-up and formalized work instructions ready for handoff to Manufacturing Operations

• Define and/or design reagent storage, custom consumables, labeling and packaging design & materials

• Define and execute reagent, consumable, and kit verification and validation criteria and protocols

• Develop analytical and functional acceptance criteria and QC metrics for all related DNA Script Product lines

• Specify raw materials acceptance criteria and specifications

• Conceive, develop, and validate new QC methods and specifications

• Lead efforts with Manufacturing Operations to ensure specs are finalized, BOMs, SOPs/Work Instructions, QC protocols are finalized and ready for process validation.

• Develop content for Instructions for Use and/or User Guides and transfer to Technical Support

• Partner with Manufacturing on Alpha Builds for testing and Early Access programs

• Partner with Product Marketing and Sales to provide data as needed to ensure successful product launch

• Hire and mentor a successful development team

Experience:

• Masters or Ph.D. in Molecular Biology, Biotechnology, Genetics or equivalent

• At least 10 years of experience in developing life science reagents for the US and other key markets, with at least 5 years of leadership responsibility

• Demonstrated success in developing and optimizing molecular biology reagent kits, custom consumables, and/or assays

• In depth knowledge of molecular and analytical techniques such as DNA synthesis, NGS, qPCR, nucleic acid characterization, capillary electrophoresis, HPLC, and spectroscopic techniques

• Excellent organizational skills and attention to detail

• Excellent verbal and written communication skills

• Strong supervisory skills and a thoughtful and effective approach to department leadership

Ideal Candidate will have:

• Excellent project management skills with a proven ability to meet deadlines and drive to product launch

• Strong analytical and problem-solving skills

• Ability to prioritize tasks and to delegate them when appropriate

• Ability to function well in a high-paced and at times stressful environment

• Proficient with statistical analysis software

Miscellaneous

• Job located in Paris

• Frequent travel between global DNA Script sites

• Start date: asap

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