Bioprocess Engineer

**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** **Main Responsibilities** - Work in a cross-functional Product Development team on reagent technical transfer from R&D to Manufacturing - Drive the transfer and scale-up of reagents (enzymes, buffers) from development to production in a regulated manufacturing environment - Design, size, develop, and/or source new production equipment and establish safe production processes - Develop and conduct controlled experiments (including DOEs) to optimize processes, address yield and quality issues, reduce costs, and drive implementation of solutions to meet production goals - Utilize process engineering methodologies, such as FMEA, SPC, gauge R&R, critical process parameters (CPP), or similar, to measure and improve process capability and robustness - Ensure that GLP/GMP practices are being followed in Product Development Laboratories and in Manufacturing - Author and/or reviewer of technical documents, such as engineering reports, test protocols, Batch Manufacturing Records, validation reports, or changes to existing documentation or processes - Analyze, trend, and monitor process parameters, and present reports to cross-functional teams **Qualifications and Education Requirements** - Master's degree within life science, bio-engineering or related fields - 5+ years of work experience with bioproduction required - Experience in a regulated and/or GMP or ISO environment required - Knowledge in transfer to manufacturing required - High level problem-solving and reasoning skills required - Excellent verbal/written communication skills with many stakeholders of diverse backgrounds and an ability to accomplish goals while working across departments is required - Mandatory: Fluent French speaker, good professional English **Preferred Skills and Abilities** - Ability to prioritize activities in a constantly changing, fast paced environment - Ability to learn new technologies/processes quickly and determine impacts to multiple operations-related business areas (Product Development, QA, Validation, Manufacturing) - Experience with statistics, statistical process control, statistical analysis software (e.g. JMP, Minitab), and DOE techniques preferred - Experience with product development processes and project management preferred - Analytical testing method validation and transfer experience preferred **Miscellaneous** - Job located in Kremlin Bicêtre - Start date: As soon as possible **Other Benefits**: - Product Dev mindset - GMP sensibility - Scale-up / automated production lines experience - Communication skills in French and in English (both are needed) **Recruitment Process** - Initial screening with the hiring manager n+1 - D