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Project Leader, QC Method for Reagent Product Development

Permanent contract
Le Kremlin-Bicêtre
Salary: Not specified
No remote work

DNA Script
DNA Script

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Job description

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 candidate selected for this role will work in a new team within DNA Script’s Reagent 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 and QC. The candidate will be responsible of developing hands -on QC reagent tests, reagents guard banding tests, reagent packaging tests by mainly performing a variety of tests ranging from pH conductivity measurements, HPLC, qPCR,. To do so the candidate will also be performing enzymatic synthesis on a liquid handler, analyzing and documenting the results.

They will be collaborating with the R&D team, the manufacturing team and the QC team and will be directly involved in the reporting of DNA Script product performances and contribute to their improvement. The position will require a lot of transversal and interdisciplinary communication mostly with the manufacturing team and QC team in France and US and the R&D synthesis team.

The position will be based in the Paris Headquarters.

Responsibilities:

  • Provide strategic and technical leadership, in collaboration with the QC team in defining QC test methods for reagent, consumable, and kits
    • Propose, optimize and test QC methods
    • Determine standard QC methods characteristics such as linearity, LOD, LOQ, reproducibility
    • Involvement in determination of QC methods, significant range and threshold relevant to the QC product or process.
    • Ensure compliance with safety and quality standards compatible with ISO 13485
  • Establish performance specifications of incoming and outgoing material, establish analytical and functional tests required for qualifying raw material and finished goods
  • Conceive, develop, and validate new QC methods and specifications for buffer formulations, enzymes, nucleotide and other raw material
    • Develop analytical and functional acceptance criteria and QC metrics for all related DNA Script Product lines
    • Establish guardbanding experiments to provide Pass or fail criteria to QC
    • Train QC team to the new or improved QC methods.
  • Ensure good communication and efficient work between R&D analytics, Product dev reagent and QC
    • Translate R&D QC test methods in validated QC Test methods instructions
    • Write work instructions for test methods in collaboration with QC taking into account their analytical equipments with easy to implement QC methods for reagent analysis
    • Ensure specs are finalized for QC protocols, that test methods are finalized and ready for QC testing and validation.
  • Participation in inter site QC method verification and validation criteria and protocols
  • Engage in good laboratory/documentation practices, write Standard Operating Procedures (SOPs) and enforce their correct use.
  • Regularly present and report across all levels of the company.
  • Actively contribute to critical company milestones, with a willingness to work outside immediate area of expertise when required.

Experience:

  • Masters or Ph.D. in Molecular Biology, Biotechnology, Genetics or equivalent
  • At least 5 years of experience in developing/validating QC methods for life science reagents, diagnostic kits or cosmetics
  • Demonstrated success in optimizing QC methods for 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
  • Understanding of manufacturing processes and quality/safety regulations (ISO 13485, BPL/GLP BPF/GMP))
  • Fluent in French & Professional Level of English

Ideal Candidate will have:

  • 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

Contact

hiring@dnascript.co

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