We are seeking a highly experienced and innovative Process Engineer to support process development activities for Codexis’ Enzyme Catalyzed Oligonucleotide (ECO) Synthesis® manufacturing platform, driving innovation and scalability from bench to GMP production. This role is pivotal in advancing sustainable oligonucleotide manufacturing technologies that disrupt traditional chemical synthesis methods and meet stringent quality and regulatory standards.
If any of the below describes you, we would love to meet you!
- Possess a passion for being part of the therapeutic community helping bring cutting edge treatments to patients in need.
- Enjoys collaboration across different functional groups to get a holistic understanding of process development along with aligning data with internal stakeholders.
- Enjoys problem solving by implementing engineering and analytical solutions.
Responsibilities
- Providing technical leadership in hands-on process development, applying advanced engineering principles to drive the design, build-out, and maturation of the ECO Synthesis® platform in close partnership with cross-functional development teams
- Leading the scale-up strategy for the ECO Synthesis® platform, ensuring process is robust, well-characterized, and ready for transition into a cGMP manufacturing environment.
- Championing laboratory safety, maintaining a clean and compliant workspace, conducting process hazard analyses and risk assessments, and ensuring safe working environment for all team members.
- Overseeing documentation quality, ensuring batch records, SOPs, and development reports meet GDP standards; providing mentorship and guidance to early-career engineers and scientists on documentation and experimental/statistical rigor.
- Leading the development and delivery of key technical work, including internal and external presentations, detailed technical reports, and comprehensive technology transfer packages for siRNA manufacturing processes.
- Owning the creation of engineering design tools, including mass and energy balances, process flow diagrams (PFDs), equipment specifications, and cost models to support scale-up, facility integration, and long-term platform deployment.
- Serving as primary technical liaison with external vendors, driving equipment selection, qualification, and support activities essential for effective process development and scale-up.
